際際滷shows by User: TrialJoin / http://www.slideshare.net/images/logo.gif 際際滷shows by User: TrialJoin / Wed, 20 Sep 2017 04:58:27 GMT 際際滷Share feed for 際際滷shows by User: TrialJoin What to Do When There Are Adverse Events and Serious Adverse Events /slideshow/what-to-do-when-there-are-adverse-events-and-serious-adverse-events/79963554 pwr11bxftf2je5yydtyh-signature-e886e8bb1fb45d964c5cb5ddc8d81a473bc1ce55b312edea44e5dddfa7800b5c-poli-170920045828
Clinical trials are experimental studies where the efficiency and safety of a new drug are being tested. For this reason, patients who decide to participate need to sign an informed consent form which states that theyre aware of the risks and benefits associated with the study drug or investigational product. With all this in mind, its expected that as some point, some patients will experience adverse events or even serious adverse events. At the site level, its important to know what to do when this happens. What do you do when a patient experiences an adverse event? What do you do when its a serious adverse event? Whose job is it to deal with these cases? Who should report this and to whom? What should the CRA do? What should the PI and coordinator do? All of these questions are crucial in case of such situations. ]]>
Clinical trials are experimental studies where the efficiency and safety of a new drug are being tested. For this reason, patients who decide to participate need to sign an informed consent form which states that theyre aware of the risks and benefits associated with the study drug or investigational product. With all this in mind, its expected that as some point, some patients will experience adverse events or even serious adverse events. At the site level, its important to know what to do when this happens. What do you do when a patient experiences an adverse event? What do you do when its a serious adverse event? Whose job is it to deal with these cases? Who should report this and to whom? What should the CRA do? What should the PI and coordinator do? All of these questions are crucial in case of such situations. ]]> Wed, 20 Sep 2017 04:58:27 GMT /slideshow/what-to-do-when-there-are-adverse-events-and-serious-adverse-events/79963554 TrialJoin@slideshare.net(TrialJoin) What to Do When There Are Adverse Events and Serious Adverse Events TrialJoin Clinical trials are experimental studies where the efficiency and safety of a new drug are being tested. For this reason, patients who decide to participate need to sign an informed consent form which states that theyre aware of the risks and benefits associated with the study drug or investigational product. With all this in mind, its expected that as some point, some patients will experience adverse events or even serious adverse events. At the site level, its important to know what to do when this happens. What do you do when a patient experiences an adverse event? What do you do when its a serious adverse event? Whose job is it to deal with these cases? Who should report this and to whom? What should the CRA do? What should the PI and coordinator do? All of these questions are crucial in case of such situations. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/pwr11bxftf2je5yydtyh-signature-e886e8bb1fb45d964c5cb5ddc8d81a473bc1ce55b312edea44e5dddfa7800b5c-poli-170920045828-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Clinical trials are experimental studies where the efficiency and safety of a new drug are being tested. For this reason, patients who decide to participate need to sign an informed consent form which states that theyre aware of the risks and benefits associated with the study drug or investigational product. With all this in mind, its expected that as some point, some patients will experience adverse events or even serious adverse events. At the site level, its important to know what to do when this happens. What do you do when a patient experiences an adverse event? What do you do when its a serious adverse event? Whose job is it to deal with these cases? Who should report this and to whom? What should the CRA do? What should the PI and coordinator do? All of these questions are crucial in case of such situations.
What to Do When There Are Adverse Events and Serious Adverse Events from TrialJoin
]]> 4130 4 https://cdn.slidesharecdn.com/ss_thumbnails/pwr11bxftf2je5yydtyh-signature-e886e8bb1fb45d964c5cb5ddc8d81a473bc1ce55b312edea44e5dddfa7800b5c-poli-170920045828-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 New Drug Application - How to Speed Up FDA Approval /slideshow/new-drug-application-how-to-speed-up-fda-approval-79963553/79963553 hzzq5ekgs42r9xf56v2d-signature-e886e8bb1fb45d964c5cb5ddc8d81a473bc1ce55b312edea44e5dddfa7800b5c-poli-170920045828
We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug. Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, whats the purpose of it all? What happens after the trials end? After a trial ends, the sponsor determines if it went well enough for him to be able to submit a New Drug Application to the FDA. An NDA is submitted in order for the FDA to approve the new investigational product on the market. So, here well discuss the ways in which the FDA reviews the NDA and ways in which you can increase your chances to get approved. ]]>
We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug. Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, whats the purpose of it all? What happens after the trials end? After a trial ends, the sponsor determines if it went well enough for him to be able to submit a New Drug Application to the FDA. An NDA is submitted in order for the FDA to approve the new investigational product on the market. So, here well discuss the ways in which the FDA reviews the NDA and ways in which you can increase your chances to get approved. ]]> Wed, 20 Sep 2017 04:58:27 GMT /slideshow/new-drug-application-how-to-speed-up-fda-approval-79963553/79963553 TrialJoin@slideshare.net(TrialJoin) New Drug Application - How to Speed Up FDA Approval TrialJoin We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug. Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, whats the purpose of it all? What happens after the trials end? After a trial ends, the sponsor determines if it went well enough for him to be able to submit a New Drug Application to the FDA. An NDA is submitted in order for the FDA to approve the new investigational product on the market. So, here well discuss the ways in which the FDA reviews the NDA and ways in which you can increase your chances to get approved. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/hzzq5ekgs42r9xf56v2d-signature-e886e8bb1fb45d964c5cb5ddc8d81a473bc1ce55b312edea44e5dddfa7800b5c-poli-170920045828-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug. Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, whats the purpose of it all? What happens after the trials end? After a trial ends, the sponsor determines if it went well enough for him to be able to submit a New Drug Application to the FDA. An NDA is submitted in order for the FDA to approve the new investigational product on the market. So, here well discuss the ways in which the FDA reviews the NDA and ways in which you can increase your chances to get approved.
New Drug Application - How to Speed Up FDA Approval from TrialJoin
]]> 890 8 https://cdn.slidesharecdn.com/ss_thumbnails/hzzq5ekgs42r9xf56v2d-signature-e886e8bb1fb45d964c5cb5ddc8d81a473bc1ce55b312edea44e5dddfa7800b5c-poli-170920045828-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Negotiating Clinical Research Budgets: Most Commonly Neglected Items /slideshow/negotiating-clinical-research-budgets-most-commonly-neglected-items-79963282/79963282 ai8ftfarkenonnikwdvw-signature-80ec0337a0b9f4cc73ce2714df731ea15327ff0c0758749c342f7e44ec3a190c-poli-170920044626
As a clinical research site trying to get a better budget for a study, you need to remember that every item of a budget is negotiable. Being a good negotiator will allow you to get more out of every study you conduct at your site. In this article, well teach you how to reach a win-win negotiation, as well as remind you of some of the most commonly neglected items in clinical trial budgets. Negotiating a budget is usually a long process and there are going to be many disagreements until you finally reach a mutually-beneficial deal, so continue reading and learning in order to achieve your goals and conduct a profitable study. ]]>
As a clinical research site trying to get a better budget for a study, you need to remember that every item of a budget is negotiable. Being a good negotiator will allow you to get more out of every study you conduct at your site. In this article, well teach you how to reach a win-win negotiation, as well as remind you of some of the most commonly neglected items in clinical trial budgets. Negotiating a budget is usually a long process and there are going to be many disagreements until you finally reach a mutually-beneficial deal, so continue reading and learning in order to achieve your goals and conduct a profitable study. ]]> Wed, 20 Sep 2017 04:46:26 GMT /slideshow/negotiating-clinical-research-budgets-most-commonly-neglected-items-79963282/79963282 TrialJoin@slideshare.net(TrialJoin) Negotiating Clinical Research Budgets: Most Commonly Neglected Items TrialJoin As a clinical research site trying to get a better budget for a study, you need to remember that every item of a budget is negotiable. Being a good negotiator will allow you to get more out of every study you conduct at your site. In this article, well teach you how to reach a win-win negotiation, as well as remind you of some of the most commonly neglected items in clinical trial budgets. Negotiating a budget is usually a long process and there are going to be many disagreements until you finally reach a mutually-beneficial deal, so continue reading and learning in order to achieve your goals and conduct a profitable study. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ai8ftfarkenonnikwdvw-signature-80ec0337a0b9f4cc73ce2714df731ea15327ff0c0758749c342f7e44ec3a190c-poli-170920044626-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> As a clinical research site trying to get a better budget for a study, you need to remember that every item of a budget is negotiable. Being a good negotiator will allow you to get more out of every study you conduct at your site. In this article, well teach you how to reach a win-win negotiation, as well as remind you of some of the most commonly neglected items in clinical trial budgets. Negotiating a budget is usually a long process and there are going to be many disagreements until you finally reach a mutually-beneficial deal, so continue reading and learning in order to achieve your goals and conduct a profitable study.
Negotiating Clinical Research Budgets: Most Commonly Neglected Items from TrialJoin
]]> 526 5 https://cdn.slidesharecdn.com/ss_thumbnails/ai8ftfarkenonnikwdvw-signature-80ec0337a0b9f4cc73ce2714df731ea15327ff0c0758749c342f7e44ec3a190c-poli-170920044626-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Most Common Clinical Research Site Worries and Complaints /slideshow/most-common-clinical-research-site-worries-and-complaints-79963076/79963076 1hqdnwphre611v3migd1-signature-11d858d5ec1d7fb154c2fd5ba8b844af2a4c78a3c8a225b55eb2848d769800c4-poli-170920043932
All clinical research sites, especially new ones whove just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible. There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. Weve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, well give you answers to all your questions. ]]>
All clinical research sites, especially new ones whove just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible. There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. Weve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, well give you answers to all your questions. ]]> Wed, 20 Sep 2017 04:39:32 GMT /slideshow/most-common-clinical-research-site-worries-and-complaints-79963076/79963076 TrialJoin@slideshare.net(TrialJoin) Most Common Clinical Research Site Worries and Complaints TrialJoin All clinical research sites, especially new ones whove just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible. There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. Weve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, well give you answers to all your questions. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/1hqdnwphre611v3migd1-signature-11d858d5ec1d7fb154c2fd5ba8b844af2a4c78a3c8a225b55eb2848d769800c4-poli-170920043932-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> All clinical research sites, especially new ones whove just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible. There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. Weve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, well give you answers to all your questions.
Most Common Clinical Research Site Worries and Complaints from TrialJoin
]]> 769 8 https://cdn.slidesharecdn.com/ss_thumbnails/1hqdnwphre611v3migd1-signature-11d858d5ec1d7fb154c2fd5ba8b844af2a4c78a3c8a225b55eb2848d769800c4-poli-170920043932-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Explaining the Different Types of Routine Monitoring Visits /TrialJoin/explaining-the-different-types-of-routine-monitoring-visits-79962839 lfkjlenor4opriesdcxd-signature-e6b28c193e48a8770a5efd296d193cc0984d3f7466f2940df6329af20699e000-poli-170920043209
In the clinical research industry, there are several types of basic monitoring visits that everyone involved in it should differentiate, especially CRAs (monitors). A CRA (clinical research associate) or a monitor is the person responsible for visiting a site in order to ensure that the clinical trial is being conducted properly. The CRAs tasks include on-site visits and ensuring compliance, subjects safety, data quality and integrity, etc. Although clinical trials belong in the medical field, a CRA doesnt have to be a doctor or a medical professional. Its enough if a CRA has a background in Life Sciences, past experience in clinical trials (most often as a coordinator), and the proper training. ]]>
In the clinical research industry, there are several types of basic monitoring visits that everyone involved in it should differentiate, especially CRAs (monitors). A CRA (clinical research associate) or a monitor is the person responsible for visiting a site in order to ensure that the clinical trial is being conducted properly. The CRAs tasks include on-site visits and ensuring compliance, subjects safety, data quality and integrity, etc. Although clinical trials belong in the medical field, a CRA doesnt have to be a doctor or a medical professional. Its enough if a CRA has a background in Life Sciences, past experience in clinical trials (most often as a coordinator), and the proper training. ]]> Wed, 20 Sep 2017 04:32:09 GMT /TrialJoin/explaining-the-different-types-of-routine-monitoring-visits-79962839 TrialJoin@slideshare.net(TrialJoin) Explaining the Different Types of Routine Monitoring Visits TrialJoin In the clinical research industry, there are several types of basic monitoring visits that everyone involved in it should differentiate, especially CRAs (monitors). A CRA (clinical research associate) or a monitor is the person responsible for visiting a site in order to ensure that the clinical trial is being conducted properly. The CRAs tasks include on-site visits and ensuring compliance, subjects safety, data quality and integrity, etc. Although clinical trials belong in the medical field, a CRA doesnt have to be a doctor or a medical professional. Its enough if a CRA has a background in Life Sciences, past experience in clinical trials (most often as a coordinator), and the proper training. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/lfkjlenor4opriesdcxd-signature-e6b28c193e48a8770a5efd296d193cc0984d3f7466f2940df6329af20699e000-poli-170920043209-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> In the clinical research industry, there are several types of basic monitoring visits that everyone involved in it should differentiate, especially CRAs (monitors). A CRA (clinical research associate) or a monitor is the person responsible for visiting a site in order to ensure that the clinical trial is being conducted properly. The CRAs tasks include on-site visits and ensuring compliance, subjects safety, data quality and integrity, etc. Although clinical trials belong in the medical field, a CRA doesnt have to be a doctor or a medical professional. Its enough if a CRA has a background in Life Sciences, past experience in clinical trials (most often as a coordinator), and the proper training.
Explaining the Different Types of Routine Monitoring Visits from TrialJoin
]]> 2272 6 https://cdn.slidesharecdn.com/ss_thumbnails/lfkjlenor4opriesdcxd-signature-e6b28c193e48a8770a5efd296d193cc0984d3f7466f2940df6329af20699e000-poli-170920043209-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Essentials for Setting up a New Clinical Research Center /TrialJoin/essentials-for-setting-up-a-new-clinical-research-center-79962649 fkmpivwiqbiqxvlcgxeu-signature-61efcfb4ac18ebf08718126d6764316600974eaa53e5f726edfc6698656ddb48-poli-170920042623
This one is for all the doctors and medical specialists who are interested in opening up their own research clinic. As a doctor whos interested in this option, we imagine that youve already seen a clinical research environment either by participating as a sub-investigator or a PI (principal investigator). If this is the case and youre already familiar with everything that clinical research entails, then youre in a good position to start your own clinical research center or research clinic. ]]>
This one is for all the doctors and medical specialists who are interested in opening up their own research clinic. As a doctor whos interested in this option, we imagine that youve already seen a clinical research environment either by participating as a sub-investigator or a PI (principal investigator). If this is the case and youre already familiar with everything that clinical research entails, then youre in a good position to start your own clinical research center or research clinic. ]]> Wed, 20 Sep 2017 04:26:23 GMT /TrialJoin/essentials-for-setting-up-a-new-clinical-research-center-79962649 TrialJoin@slideshare.net(TrialJoin) Essentials for Setting up a New Clinical Research Center TrialJoin This one is for all the doctors and medical specialists who are interested in opening up their own research clinic. As a doctor whos interested in this option, we imagine that youve already seen a clinical research environment either by participating as a sub-investigator or a PI (principal investigator). If this is the case and youre already familiar with everything that clinical research entails, then youre in a good position to start your own clinical research center or research clinic. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/fkmpivwiqbiqxvlcgxeu-signature-61efcfb4ac18ebf08718126d6764316600974eaa53e5f726edfc6698656ddb48-poli-170920042623-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> This one is for all the doctors and medical specialists who are interested in opening up their own research clinic. As a doctor whos interested in this option, we imagine that youve already seen a clinical research environment either by participating as a sub-investigator or a PI (principal investigator). If this is the case and youre already familiar with everything that clinical research entails, then youre in a good position to start your own clinical research center or research clinic.
Essentials for Setting up a New Clinical Research Center from TrialJoin
]]> 2281 8 https://cdn.slidesharecdn.com/ss_thumbnails/fkmpivwiqbiqxvlcgxeu-signature-61efcfb4ac18ebf08718126d6764316600974eaa53e5f726edfc6698656ddb48-poli-170920042623-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Essential Regulatory Documents in Clinical Trials /slideshow/essential-regulatory-documents-in-clinical-trials/79962461 i2c7ebszr5giioa9yfso-signature-01f6f3aede8fbbbec2fd98557c93a234fea2e874ae26e7cf2b3b8ca820812713-poli-170920042120
The term essential documents refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc. Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) thats provided to the site for that specific study. Filling out these documents and filing them properly is the sites and especially the PIs responsibility. Storing them properly is also the sites responsibility, not the CRAs. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site. ]]>
The term essential documents refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc. Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) thats provided to the site for that specific study. Filling out these documents and filing them properly is the sites and especially the PIs responsibility. Storing them properly is also the sites responsibility, not the CRAs. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site. ]]> Wed, 20 Sep 2017 04:21:20 GMT /slideshow/essential-regulatory-documents-in-clinical-trials/79962461 TrialJoin@slideshare.net(TrialJoin) Essential Regulatory Documents in Clinical Trials TrialJoin The term essential documents refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc. Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) thats provided to the site for that specific study. Filling out these documents and filing them properly is the sites and especially the PIs responsibility. Storing them properly is also the sites responsibility, not the CRAs. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/i2c7ebszr5giioa9yfso-signature-01f6f3aede8fbbbec2fd98557c93a234fea2e874ae26e7cf2b3b8ca820812713-poli-170920042120-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> The term essential documents refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc. Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) thats provided to the site for that specific study. Filling out these documents and filing them properly is the sites and especially the PIs responsibility. Storing them properly is also the sites responsibility, not the CRAs. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
Essential Regulatory Documents in Clinical Trials from TrialJoin
]]> 2479 6 https://cdn.slidesharecdn.com/ss_thumbnails/i2c7ebszr5giioa9yfso-signature-01f6f3aede8fbbbec2fd98557c93a234fea2e874ae26e7cf2b3b8ca820812713-poli-170920042120-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Clinical Project Manager: Leading Causes of Problem Solving Inefficiencies /slideshow/clinical-project-manager-leading-causes-of-problem-solving-inefficiencies-79962283/79962283 cnrk6ehvr8urt5nj695j-signature-4bbe2cae2787021b2bc6bf6696f0d56cdddce14b6943df1cd8235e2c72f97092-poli-170920041521
A Clinical Project Manager (CPM) job is a high-rank position in the research world that many CRAs and investigators are aiming to reach. Being a Clinical Project Manager entails careful thinking, planning, and managing all features of a trial or study. The CPMs role is to act as a middleman between the sponsor and the site. This means that he or she will be responsible for managing and leading CRAs and other site medical specialists such as PIs, sub-investigators, nurses, coordinators, etc. ]]>
A Clinical Project Manager (CPM) job is a high-rank position in the research world that many CRAs and investigators are aiming to reach. Being a Clinical Project Manager entails careful thinking, planning, and managing all features of a trial or study. The CPMs role is to act as a middleman between the sponsor and the site. This means that he or she will be responsible for managing and leading CRAs and other site medical specialists such as PIs, sub-investigators, nurses, coordinators, etc. ]]> Wed, 20 Sep 2017 04:15:21 GMT /slideshow/clinical-project-manager-leading-causes-of-problem-solving-inefficiencies-79962283/79962283 TrialJoin@slideshare.net(TrialJoin) Clinical Project Manager: Leading Causes of Problem Solving Inefficiencies TrialJoin A Clinical Project Manager (CPM) job is a high-rank position in the research world that many CRAs and investigators are aiming to reach. Being a Clinical Project Manager entails careful thinking, planning, and managing all features of a trial or study. The CPMs role is to act as a middleman between the sponsor and the site. This means that he or she will be responsible for managing and leading CRAs and other site medical specialists such as PIs, sub-investigators, nurses, coordinators, etc. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/cnrk6ehvr8urt5nj695j-signature-4bbe2cae2787021b2bc6bf6696f0d56cdddce14b6943df1cd8235e2c72f97092-poli-170920041521-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> A Clinical Project Manager (CPM) job is a high-rank position in the research world that many CRAs and investigators are aiming to reach. Being a Clinical Project Manager entails careful thinking, planning, and managing all features of a trial or study. The CPMs role is to act as a middleman between the sponsor and the site. This means that he or she will be responsible for managing and leading CRAs and other site medical specialists such as PIs, sub-investigators, nurses, coordinators, etc.
Clinical Project Manager: Leading Causes of Problem Solving Inefficiencies from TrialJoin
]]> 735 6 https://cdn.slidesharecdn.com/ss_thumbnails/cnrk6ehvr8urt5nj695j-signature-4bbe2cae2787021b2bc6bf6696f0d56cdddce14b6943df1cd8235e2c72f97092-poli-170920041521-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Financing - Investigator Payment Models & Best Budget Practices /slideshow/financing-investigator-payment-models-best-budget-practices-77513488/77513488 financing-investigatorpaymentmodelsbestbudgetpractices-170704203438
Aside from being a vital part to medical advancement, a clinical trial is a complex and expensive business which requires great planning and strategy. One big part of a successful trial are the finances. Financing clinical trials is a task that involves careful planning, anticipation, and negotiation of costs, budgets, and compensation to investigators. Taking into consideration the great number of items, procedures, protocols, subjects, and visits, it can be challenging to not miss or forget an item when you're preparing your budget. Managing to get the necessary budget that you need for covering all costs of conducting a trial requires careful anticipation and great negotiation skills. When negotiating your budget and explaining all the costs and expenses to sponsors, you have to take into consideration the costs for paying your investigators. In this article, we'll explain all the different payment models for investigators as well as give you some great tips and techniques to help you allocate and negotiate your budget in a better way. Doing this will help you work with a profit, while still being able to cover all your trial expenses. ]]>
Aside from being a vital part to medical advancement, a clinical trial is a complex and expensive business which requires great planning and strategy. One big part of a successful trial are the finances. Financing clinical trials is a task that involves careful planning, anticipation, and negotiation of costs, budgets, and compensation to investigators. Taking into consideration the great number of items, procedures, protocols, subjects, and visits, it can be challenging to not miss or forget an item when you're preparing your budget. Managing to get the necessary budget that you need for covering all costs of conducting a trial requires careful anticipation and great negotiation skills. When negotiating your budget and explaining all the costs and expenses to sponsors, you have to take into consideration the costs for paying your investigators. In this article, we'll explain all the different payment models for investigators as well as give you some great tips and techniques to help you allocate and negotiate your budget in a better way. Doing this will help you work with a profit, while still being able to cover all your trial expenses. ]]> Tue, 04 Jul 2017 20:34:38 GMT /slideshow/financing-investigator-payment-models-best-budget-practices-77513488/77513488 TrialJoin@slideshare.net(TrialJoin) Financing - Investigator Payment Models & Best Budget Practices TrialJoin Aside from being a vital part to medical advancement, a clinical trial is a complex and expensive business which requires great planning and strategy. One big part of a successful trial are the finances. Financing clinical trials is a task that involves careful planning, anticipation, and negotiation of costs, budgets, and compensation to investigators. Taking into consideration the great number of items, procedures, protocols, subjects, and visits, it can be challenging to not miss or forget an item when you're preparing your budget. Managing to get the necessary budget that you need for covering all costs of conducting a trial requires careful anticipation and great negotiation skills. When negotiating your budget and explaining all the costs and expenses to sponsors, you have to take into consideration the costs for paying your investigators. In this article, we'll explain all the different payment models for investigators as well as give you some great tips and techniques to help you allocate and negotiate your budget in a better way. Doing this will help you work with a profit, while still being able to cover all your trial expenses. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/financing-investigatorpaymentmodelsbestbudgetpractices-170704203438-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Aside from being a vital part to medical advancement, a clinical trial is a complex and expensive business which requires great planning and strategy. One big part of a successful trial are the finances. Financing clinical trials is a task that involves careful planning, anticipation, and negotiation of costs, budgets, and compensation to investigators. Taking into consideration the great number of items, procedures, protocols, subjects, and visits, it can be challenging to not miss or forget an item when you&#39;re preparing your budget. Managing to get the necessary budget that you need for covering all costs of conducting a trial requires careful anticipation and great negotiation skills. When negotiating your budget and explaining all the costs and expenses to sponsors, you have to take into consideration the costs for paying your investigators. In this article, we&#39;ll explain all the different payment models for investigators as well as give you some great tips and techniques to help you allocate and negotiate your budget in a better way. Doing this will help you work with a profit, while still being able to cover all your trial expenses.
Financing - Investigator Payment Models & Best Budget Practices from TrialJoin
]]> 486 4 https://cdn.slidesharecdn.com/ss_thumbnails/financing-investigatorpaymentmodelsbestbudgetpractices-170704203438-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Legal Compensation for Referring Doctors in Clinical Trials /slideshow/legal-compensation-for-referring-doctors-in-clinical-trials/77474486 legalcompensationforreferringdoctorsinclinicaltrials-170703194121
As we all know, the best way for clinical research sites to recruit patients is through patient referrals. These referrals usually come either from the PI (principal investigator) or more often from other referring physicians. Physicians who refer patients to your site can work independently or work as your sub-investigators. Now, when these physicians are your sub-Is youll have to find the proper way to compensate them. Many sites experience challenges related to sub-I compensation for referrals. The way in which you choose to compensate these sub-investigators for referring patients to you should be legal and it shouldnt interfere with Anti-Kickback Statute or the IRB. So, how can clinical research sites do this? How do we compensate sub-Is in a legal way? Were here to tell you that there are actually many ways in which this can be done. Below, well give you the best solutions to this common problem. ]]>
As we all know, the best way for clinical research sites to recruit patients is through patient referrals. These referrals usually come either from the PI (principal investigator) or more often from other referring physicians. Physicians who refer patients to your site can work independently or work as your sub-investigators. Now, when these physicians are your sub-Is youll have to find the proper way to compensate them. Many sites experience challenges related to sub-I compensation for referrals. The way in which you choose to compensate these sub-investigators for referring patients to you should be legal and it shouldnt interfere with Anti-Kickback Statute or the IRB. So, how can clinical research sites do this? How do we compensate sub-Is in a legal way? Were here to tell you that there are actually many ways in which this can be done. Below, well give you the best solutions to this common problem. ]]> Mon, 03 Jul 2017 19:41:21 GMT /slideshow/legal-compensation-for-referring-doctors-in-clinical-trials/77474486 TrialJoin@slideshare.net(TrialJoin) Legal Compensation for Referring Doctors in Clinical Trials TrialJoin As we all know, the best way for clinical research sites to recruit patients is through patient referrals. These referrals usually come either from the PI (principal investigator) or more often from other referring physicians. Physicians who refer patients to your site can work independently or work as your sub-investigators. Now, when these physicians are your sub-Is youll have to find the proper way to compensate them. Many sites experience challenges related to sub-I compensation for referrals. The way in which you choose to compensate these sub-investigators for referring patients to you should be legal and it shouldnt interfere with Anti-Kickback Statute or the IRB. So, how can clinical research sites do this? How do we compensate sub-Is in a legal way? Were here to tell you that there are actually many ways in which this can be done. Below, well give you the best solutions to this common problem. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/legalcompensationforreferringdoctorsinclinicaltrials-170703194121-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> As we all know, the best way for clinical research sites to recruit patients is through patient referrals. These referrals usually come either from the PI (principal investigator) or more often from other referring physicians. Physicians who refer patients to your site can work independently or work as your sub-investigators. Now, when these physicians are your sub-Is youll have to find the proper way to compensate them. Many sites experience challenges related to sub-I compensation for referrals. The way in which you choose to compensate these sub-investigators for referring patients to you should be legal and it shouldnt interfere with Anti-Kickback Statute or the IRB. So, how can clinical research sites do this? How do we compensate sub-Is in a legal way? Were here to tell you that there are actually many ways in which this can be done. Below, well give you the best solutions to this common problem.
Legal Compensation for Referring Doctors in Clinical Trials from TrialJoin
]]> 1464 12 https://cdn.slidesharecdn.com/ss_thumbnails/legalcompensationforreferringdoctorsinclinicaltrials-170703194121-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Explaining the Importance of Feasibility Questionnaires and Site Selection Visits /TrialJoin/explaining-the-importance-of-feasibility-questionnaires-and-site-selection-visits-77473929 explainingtheimportanceoffeasibilityquestionnairesandsiteselectionvisits-170703192352
No matter if youre reading this because you aspire to become a CRA, or youre a study coordinator, or maybe youre part of a research site, learning about feasibility surveys and questionnaires is important for everyone thats in any way involved in clinical trials. In this article, well try to explain to you why feasibility questionnaires and site selection visits are important and how they can affect the sponsors decision of awarding you the study. ]]>
No matter if youre reading this because you aspire to become a CRA, or youre a study coordinator, or maybe youre part of a research site, learning about feasibility surveys and questionnaires is important for everyone thats in any way involved in clinical trials. In this article, well try to explain to you why feasibility questionnaires and site selection visits are important and how they can affect the sponsors decision of awarding you the study. ]]> Mon, 03 Jul 2017 19:23:52 GMT /TrialJoin/explaining-the-importance-of-feasibility-questionnaires-and-site-selection-visits-77473929 TrialJoin@slideshare.net(TrialJoin) Explaining the Importance of Feasibility Questionnaires and Site Selection Visits TrialJoin No matter if youre reading this because you aspire to become a CRA, or youre a study coordinator, or maybe youre part of a research site, learning about feasibility surveys and questionnaires is important for everyone thats in any way involved in clinical trials. In this article, well try to explain to you why feasibility questionnaires and site selection visits are important and how they can affect the sponsors decision of awarding you the study. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/explainingtheimportanceoffeasibilityquestionnairesandsiteselectionvisits-170703192352-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> No matter if youre reading this because you aspire to become a CRA, or youre a study coordinator, or maybe youre part of a research site, learning about feasibility surveys and questionnaires is important for everyone thats in any way involved in clinical trials. In this article, well try to explain to you why feasibility questionnaires and site selection visits are important and how they can affect the sponsors decision of awarding you the study.
Explaining the Importance of Feasibility Questionnaires and Site Selection Visits from TrialJoin
]]> 418 6 https://cdn.slidesharecdn.com/ss_thumbnails/explainingtheimportanceoffeasibilityquestionnairesandsiteselectionvisits-170703192352-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Regulating the Workload of Your Clinical Research Coordinator (CRC) /slideshow/regulating-the-workload-of-your-clinical-research-coordinator-crc/77473532 regulatingtheworkloadofyourclinicalresearchcoordinatorcrc-170703191120
A CRC (clinical research coordinator) is one of the most important people regarding clinical trials. He/she is the person whos in charge of conducting the clinical trial, under the guidance of the PI (principal investigator). As the people responsible for coordinating all the activities on site, CRCs can sometimes carry a huge workload. This can quickly become a big problem not only for the CRC but also for everyone else involved in the study. Determining the right workload for your CRC is one of the most important actions that you (as a site owner or PI) should take. Ideally, a CRC should work 4 to 6 effective hours per day. However, you will notice that there will be periods of time when the CRC has to work more than 8 hours but also periods when he/she will be free most of the days. In this article, well help you find the right balance so that your CRC isnt too overworked or underworked. ]]>
A CRC (clinical research coordinator) is one of the most important people regarding clinical trials. He/she is the person whos in charge of conducting the clinical trial, under the guidance of the PI (principal investigator). As the people responsible for coordinating all the activities on site, CRCs can sometimes carry a huge workload. This can quickly become a big problem not only for the CRC but also for everyone else involved in the study. Determining the right workload for your CRC is one of the most important actions that you (as a site owner or PI) should take. Ideally, a CRC should work 4 to 6 effective hours per day. However, you will notice that there will be periods of time when the CRC has to work more than 8 hours but also periods when he/she will be free most of the days. In this article, well help you find the right balance so that your CRC isnt too overworked or underworked. ]]> Mon, 03 Jul 2017 19:11:20 GMT /slideshow/regulating-the-workload-of-your-clinical-research-coordinator-crc/77473532 TrialJoin@slideshare.net(TrialJoin) Regulating the Workload of Your Clinical Research Coordinator (CRC) TrialJoin A CRC (clinical research coordinator) is one of the most important people regarding clinical trials. He/she is the person whos in charge of conducting the clinical trial, under the guidance of the PI (principal investigator). As the people responsible for coordinating all the activities on site, CRCs can sometimes carry a huge workload. This can quickly become a big problem not only for the CRC but also for everyone else involved in the study. Determining the right workload for your CRC is one of the most important actions that you (as a site owner or PI) should take. Ideally, a CRC should work 4 to 6 effective hours per day. However, you will notice that there will be periods of time when the CRC has to work more than 8 hours but also periods when he/she will be free most of the days. In this article, well help you find the right balance so that your CRC isnt too overworked or underworked. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/regulatingtheworkloadofyourclinicalresearchcoordinatorcrc-170703191120-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> A CRC (clinical research coordinator) is one of the most important people regarding clinical trials. He/she is the person whos in charge of conducting the clinical trial, under the guidance of the PI (principal investigator). As the people responsible for coordinating all the activities on site, CRCs can sometimes carry a huge workload. This can quickly become a big problem not only for the CRC but also for everyone else involved in the study. Determining the right workload for your CRC is one of the most important actions that you (as a site owner or PI) should take. Ideally, a CRC should work 4 to 6 effective hours per day. However, you will notice that there will be periods of time when the CRC has to work more than 8 hours but also periods when he/she will be free most of the days. In this article, well help you find the right balance so that your CRC isnt too overworked or underworked.
Regulating the Workload of Your Clinical Research Coordinator (CRC) from TrialJoin
]]> 790 6 https://cdn.slidesharecdn.com/ss_thumbnails/regulatingtheworkloadofyourclinicalresearchcoordinatorcrc-170703191120-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to Know /slideshow/monitoring-plan-and-basic-monitoring-visits-everything-that-a-cra-needs-to-know-77472675/77472675 monitoringplanandbasicmonitoringvisitseverythingthatacraneedstoknow-170703183514
A monitor in a clinical trial is also called a CRA - clinical research associate. This person is a professional whos responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations, and good clinical practice. Whether you already are a CRA or youre trying to become one, the most important thing you should be aware of is the monitoring plan. You, as a CRA or a future CRA, should know what a monitoring plan is, what it serves for, and what it consists of. The second most important information for you are the monitoring visits. Below, well explain all the components of a monitoring plan, as well as which are the most basic and important monitoring visits. ]]>
A monitor in a clinical trial is also called a CRA - clinical research associate. This person is a professional whos responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations, and good clinical practice. Whether you already are a CRA or youre trying to become one, the most important thing you should be aware of is the monitoring plan. You, as a CRA or a future CRA, should know what a monitoring plan is, what it serves for, and what it consists of. The second most important information for you are the monitoring visits. Below, well explain all the components of a monitoring plan, as well as which are the most basic and important monitoring visits. ]]> Mon, 03 Jul 2017 18:35:14 GMT /slideshow/monitoring-plan-and-basic-monitoring-visits-everything-that-a-cra-needs-to-know-77472675/77472675 TrialJoin@slideshare.net(TrialJoin) Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to Know TrialJoin A monitor in a clinical trial is also called a CRA - clinical research associate. This person is a professional whos responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations, and good clinical practice. Whether you already are a CRA or youre trying to become one, the most important thing you should be aware of is the monitoring plan. You, as a CRA or a future CRA, should know what a monitoring plan is, what it serves for, and what it consists of. The second most important information for you are the monitoring visits. Below, well explain all the components of a monitoring plan, as well as which are the most basic and important monitoring visits. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/monitoringplanandbasicmonitoringvisitseverythingthatacraneedstoknow-170703183514-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> A monitor in a clinical trial is also called a CRA - clinical research associate. This person is a professional whos responsible for monitoring the clinical trial and making sure that everything is according to rules, regulations, and good clinical practice. Whether you already are a CRA or youre trying to become one, the most important thing you should be aware of is the monitoring plan. You, as a CRA or a future CRA, should know what a monitoring plan is, what it serves for, and what it consists of. The second most important information for you are the monitoring visits. Below, well explain all the components of a monitoring plan, as well as which are the most basic and important monitoring visits.
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to Know from TrialJoin
]]> 588 3 https://cdn.slidesharecdn.com/ss_thumbnails/monitoringplanandbasicmonitoringvisitseverythingthatacraneedstoknow-170703183514-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Differences Between Satellite Sites and Multi Site Research Clinics /slideshow/differences-between-satellite-sites-and-multi-site-research-clinics-77472306/77472306 differencesbetweensatellitesitesandmultisiteresearchclinics-170703182049
In the clinical research industry, there are two terms that we commonly encounter: satellite sites and multi sites. Although these two might sound the same, theyre not! The concept of a satellite site is much different than multi-site clinics. However, we can still see a large part the industry that is confusing these two terms. Below, well explain to you the difference between a satellite site and multi-site clinics. ]]>
In the clinical research industry, there are two terms that we commonly encounter: satellite sites and multi sites. Although these two might sound the same, theyre not! The concept of a satellite site is much different than multi-site clinics. However, we can still see a large part the industry that is confusing these two terms. Below, well explain to you the difference between a satellite site and multi-site clinics. ]]> Mon, 03 Jul 2017 18:20:49 GMT /slideshow/differences-between-satellite-sites-and-multi-site-research-clinics-77472306/77472306 TrialJoin@slideshare.net(TrialJoin) Differences Between Satellite Sites and Multi Site Research Clinics TrialJoin In the clinical research industry, there are two terms that we commonly encounter: satellite sites and multi sites. Although these two might sound the same, theyre not! The concept of a satellite site is much different than multi-site clinics. However, we can still see a large part the industry that is confusing these two terms. Below, well explain to you the difference between a satellite site and multi-site clinics. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/differencesbetweensatellitesitesandmultisiteresearchclinics-170703182049-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> In the clinical research industry, there are two terms that we commonly encounter: satellite sites and multi sites. Although these two might sound the same, theyre not! The concept of a satellite site is much different than multi-site clinics. However, we can still see a large part the industry that is confusing these two terms. Below, well explain to you the difference between a satellite site and multi-site clinics.
Differences Between Satellite Sites and Multi Site Research Clinics from TrialJoin
]]> 1418 4 https://cdn.slidesharecdn.com/ss_thumbnails/differencesbetweensatellitesitesandmultisiteresearchclinics-170703182049-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Standard of Care Costs vs Study-Related Costs /slideshow/standard-of-care-costs-vs-studyrelated-costs/75847836 n8v5lx8ktpwvpsitvajc-signature-f1ad6ae233ea58f3eadadfe83f0d9fa54a7b14dbf1b6752fc0c1c90eab017019-poli-170510105535
In order for a study to be conducted properly, the sponsor and the site have to negotiate a fair and mutually agreeable budget. When were talking about budgeting for a study, there are many separate items and things to be considered. One of the most intriguing points in a budget is the difference between Standard of Care costs and Research-Specific (study-related) costs. Clinical research is an area where its required that the sponsors disclose every dollar and every single amount which they pay to doctors they work with, and for this reason, calculating the standard of care costs is important when preparing the budget for a study. ]]>
In order for a study to be conducted properly, the sponsor and the site have to negotiate a fair and mutually agreeable budget. When were talking about budgeting for a study, there are many separate items and things to be considered. One of the most intriguing points in a budget is the difference between Standard of Care costs and Research-Specific (study-related) costs. Clinical research is an area where its required that the sponsors disclose every dollar and every single amount which they pay to doctors they work with, and for this reason, calculating the standard of care costs is important when preparing the budget for a study. ]]> Wed, 10 May 2017 10:55:35 GMT /slideshow/standard-of-care-costs-vs-studyrelated-costs/75847836 TrialJoin@slideshare.net(TrialJoin) Standard of Care Costs vs Study-Related Costs TrialJoin In order for a study to be conducted properly, the sponsor and the site have to negotiate a fair and mutually agreeable budget. When were talking about budgeting for a study, there are many separate items and things to be considered. One of the most intriguing points in a budget is the difference between Standard of Care costs and Research-Specific (study-related) costs. Clinical research is an area where its required that the sponsors disclose every dollar and every single amount which they pay to doctors they work with, and for this reason, calculating the standard of care costs is important when preparing the budget for a study. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/n8v5lx8ktpwvpsitvajc-signature-f1ad6ae233ea58f3eadadfe83f0d9fa54a7b14dbf1b6752fc0c1c90eab017019-poli-170510105535-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> In order for a study to be conducted properly, the sponsor and the site have to negotiate a fair and mutually agreeable budget. When were talking about budgeting for a study, there are many separate items and things to be considered. One of the most intriguing points in a budget is the difference between Standard of Care costs and Research-Specific (study-related) costs. Clinical research is an area where its required that the sponsors disclose every dollar and every single amount which they pay to doctors they work with, and for this reason, calculating the standard of care costs is important when preparing the budget for a study.
Standard of Care Costs vs Study-Related Costs from TrialJoin
]]> 463 7 https://cdn.slidesharecdn.com/ss_thumbnails/n8v5lx8ktpwvpsitvajc-signature-f1ad6ae233ea58f3eadadfe83f0d9fa54a7b14dbf1b6752fc0c1c90eab017019-poli-170510105535-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Resolving Sponsors Objections in Clinical Trials /slideshow/resolving-sponsors-objections-in-clinical-trials-75847790/75847790 emnbqakrfqc46w1awcav-signature-0ffffa29526140d5bb50575df59b04efaabdcf6cb1f68b424592f1771dfbb724-poli-170510105256
In the clinical research industry, sponsors are the ones who fund every trial. These sponsors or CROs can be pharma or bio companies which invest large amounts of money for conducting research. Sponsors will typically choose one or multiple research sites, depending on the size of the study and the required number of enrolled participants. One of the biggest concerns of all clinical research sites is being selected to conduct a study. Usually, after interested sites place a bid on a certain study, the sponsor will send a feasibility questionnaire to the sites he or she is interested in. After the sites fill out this feasibility report, the sponsor will choose one or multiple sites and go on a site selection visit. The site selection visit is the last step before youre officially given the study to conduct. For this reason, sites should be especially attentive, make sure that everything goes as planned on these visits, and ensure that everything that the sponsor is going to see at the site fits the feasibility questionnaire they filled out earlier. The site selection visit is basically a confirmation that what youve stated in the questionnaire is actually true in practice. However, no matter how much sites try to take care of every detail, sometimes the sponsor will still find an objection. When this happens, sites need to learn how to handle it properly and give the right answers. ]]>
In the clinical research industry, sponsors are the ones who fund every trial. These sponsors or CROs can be pharma or bio companies which invest large amounts of money for conducting research. Sponsors will typically choose one or multiple research sites, depending on the size of the study and the required number of enrolled participants. One of the biggest concerns of all clinical research sites is being selected to conduct a study. Usually, after interested sites place a bid on a certain study, the sponsor will send a feasibility questionnaire to the sites he or she is interested in. After the sites fill out this feasibility report, the sponsor will choose one or multiple sites and go on a site selection visit. The site selection visit is the last step before youre officially given the study to conduct. For this reason, sites should be especially attentive, make sure that everything goes as planned on these visits, and ensure that everything that the sponsor is going to see at the site fits the feasibility questionnaire they filled out earlier. The site selection visit is basically a confirmation that what youve stated in the questionnaire is actually true in practice. However, no matter how much sites try to take care of every detail, sometimes the sponsor will still find an objection. When this happens, sites need to learn how to handle it properly and give the right answers. ]]> Wed, 10 May 2017 10:52:56 GMT /slideshow/resolving-sponsors-objections-in-clinical-trials-75847790/75847790 TrialJoin@slideshare.net(TrialJoin) Resolving Sponsors Objections in Clinical Trials TrialJoin In the clinical research industry, sponsors are the ones who fund every trial. These sponsors or CROs can be pharma or bio companies which invest large amounts of money for conducting research. Sponsors will typically choose one or multiple research sites, depending on the size of the study and the required number of enrolled participants. One of the biggest concerns of all clinical research sites is being selected to conduct a study. Usually, after interested sites place a bid on a certain study, the sponsor will send a feasibility questionnaire to the sites he or she is interested in. After the sites fill out this feasibility report, the sponsor will choose one or multiple sites and go on a site selection visit. The site selection visit is the last step before youre officially given the study to conduct. For this reason, sites should be especially attentive, make sure that everything goes as planned on these visits, and ensure that everything that the sponsor is going to see at the site fits the feasibility questionnaire they filled out earlier. The site selection visit is basically a confirmation that what youve stated in the questionnaire is actually true in practice. However, no matter how much sites try to take care of every detail, sometimes the sponsor will still find an objection. When this happens, sites need to learn how to handle it properly and give the right answers. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/emnbqakrfqc46w1awcav-signature-0ffffa29526140d5bb50575df59b04efaabdcf6cb1f68b424592f1771dfbb724-poli-170510105256-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> In the clinical research industry, sponsors are the ones who fund every trial. These sponsors or CROs can be pharma or bio companies which invest large amounts of money for conducting research. Sponsors will typically choose one or multiple research sites, depending on the size of the study and the required number of enrolled participants. One of the biggest concerns of all clinical research sites is being selected to conduct a study. Usually, after interested sites place a bid on a certain study, the sponsor will send a feasibility questionnaire to the sites he or she is interested in. After the sites fill out this feasibility report, the sponsor will choose one or multiple sites and go on a site selection visit. The site selection visit is the last step before youre officially given the study to conduct. For this reason, sites should be especially attentive, make sure that everything goes as planned on these visits, and ensure that everything that the sponsor is going to see at the site fits the feasibility questionnaire they filled out earlier. The site selection visit is basically a confirmation that what youve stated in the questionnaire is actually true in practice. However, no matter how much sites try to take care of every detail, sometimes the sponsor will still find an objection. When this happens, sites need to learn how to handle it properly and give the right answers.
Resolving Sponsors Objections in Clinical Trials from TrialJoin
]]> 162 4 https://cdn.slidesharecdn.com/ss_thumbnails/emnbqakrfqc46w1awcav-signature-0ffffa29526140d5bb50575df59b04efaabdcf6cb1f68b424592f1771dfbb724-poli-170510105256-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Patient retention challenges and the best ways to solve them /slideshow/patient-retention-challenges-and-the-best-ways-to-solve-them-75847724/75847724 sqr5hc6gtp2tnvit6qo8-signature-314c39b08902e83b15c6a91962d3a959b37ae9cfb3115047d7d11cf46e18327e-poli-170510105019
As much as we want to say that patient problems stop with recruitment, this is usually not the case. In clinical research, many sites are able to recruit their necessary number of subjects, but then they start struggling to retain those patients until the end of the study. Patient retention is crucial for the development of a study and for producing good data and results in the end. However, there are cases when retention becomes a challenge. This can happen for many different reasons, some of which can be prevented by the site and some not. Seeing the high number of sites who face different problems with patient retention, well give you an idea of what are the most common challenges you might face and how to fix them as much as possible. ]]>
As much as we want to say that patient problems stop with recruitment, this is usually not the case. In clinical research, many sites are able to recruit their necessary number of subjects, but then they start struggling to retain those patients until the end of the study. Patient retention is crucial for the development of a study and for producing good data and results in the end. However, there are cases when retention becomes a challenge. This can happen for many different reasons, some of which can be prevented by the site and some not. Seeing the high number of sites who face different problems with patient retention, well give you an idea of what are the most common challenges you might face and how to fix them as much as possible. ]]> Wed, 10 May 2017 10:50:19 GMT /slideshow/patient-retention-challenges-and-the-best-ways-to-solve-them-75847724/75847724 TrialJoin@slideshare.net(TrialJoin) Patient retention challenges and the best ways to solve them TrialJoin As much as we want to say that patient problems stop with recruitment, this is usually not the case. In clinical research, many sites are able to recruit their necessary number of subjects, but then they start struggling to retain those patients until the end of the study. Patient retention is crucial for the development of a study and for producing good data and results in the end. However, there are cases when retention becomes a challenge. This can happen for many different reasons, some of which can be prevented by the site and some not. Seeing the high number of sites who face different problems with patient retention, well give you an idea of what are the most common challenges you might face and how to fix them as much as possible. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/sqr5hc6gtp2tnvit6qo8-signature-314c39b08902e83b15c6a91962d3a959b37ae9cfb3115047d7d11cf46e18327e-poli-170510105019-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> As much as we want to say that patient problems stop with recruitment, this is usually not the case. In clinical research, many sites are able to recruit their necessary number of subjects, but then they start struggling to retain those patients until the end of the study. Patient retention is crucial for the development of a study and for producing good data and results in the end. However, there are cases when retention becomes a challenge. This can happen for many different reasons, some of which can be prevented by the site and some not. Seeing the high number of sites who face different problems with patient retention, well give you an idea of what are the most common challenges you might face and how to fix them as much as possible.
Patient retention challenges and the best ways to solve them from TrialJoin
]]> 563 5 https://cdn.slidesharecdn.com/ss_thumbnails/sqr5hc6gtp2tnvit6qo8-signature-314c39b08902e83b15c6a91962d3a959b37ae9cfb3115047d7d11cf46e18327e-poli-170510105019-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Maintaining high levels of motivation and commitment of your clinical research team /slideshow/maintaining-high-levels-of-motivation-and-commitment-of-your-clinical-research-team-75847256/75847256 37zhfqkgtvadprdecybn-signature-0fa0f127e3905a0d73ad5be81cf7d236502dd161c06191da7c3aab1b40d1b1fe-poli-170510103320
Clinical research projects usually have longer duration periods, so its not surprising that your research team can start losing focus and motivation after some time. Maintaining high levels of motivation, engagement, and commitment from the PI, coordinator, and all other individuals involved in research is extremely important for a successful project. This means that you will need to maintain the engagement of each individual separately as well as the whole team. Bringing back this focus and attention can sometimes be a big challenge for CRAs, sponsors or CROs. Seeing how this problem is so common in the research community and how many people are constantly struggling with this question, weve decided to help you reach your best potential by showing you how to increase and maintain your teams motivation and engagement in your research. ]]>
Clinical research projects usually have longer duration periods, so its not surprising that your research team can start losing focus and motivation after some time. Maintaining high levels of motivation, engagement, and commitment from the PI, coordinator, and all other individuals involved in research is extremely important for a successful project. This means that you will need to maintain the engagement of each individual separately as well as the whole team. Bringing back this focus and attention can sometimes be a big challenge for CRAs, sponsors or CROs. Seeing how this problem is so common in the research community and how many people are constantly struggling with this question, weve decided to help you reach your best potential by showing you how to increase and maintain your teams motivation and engagement in your research. ]]> Wed, 10 May 2017 10:33:20 GMT /slideshow/maintaining-high-levels-of-motivation-and-commitment-of-your-clinical-research-team-75847256/75847256 TrialJoin@slideshare.net(TrialJoin) Maintaining high levels of motivation and commitment of your clinical research team TrialJoin Clinical research projects usually have longer duration periods, so its not surprising that your research team can start losing focus and motivation after some time. Maintaining high levels of motivation, engagement, and commitment from the PI, coordinator, and all other individuals involved in research is extremely important for a successful project. This means that you will need to maintain the engagement of each individual separately as well as the whole team. Bringing back this focus and attention can sometimes be a big challenge for CRAs, sponsors or CROs. Seeing how this problem is so common in the research community and how many people are constantly struggling with this question, weve decided to help you reach your best potential by showing you how to increase and maintain your teams motivation and engagement in your research. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/37zhfqkgtvadprdecybn-signature-0fa0f127e3905a0d73ad5be81cf7d236502dd161c06191da7c3aab1b40d1b1fe-poli-170510103320-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Clinical research projects usually have longer duration periods, so its not surprising that your research team can start losing focus and motivation after some time. Maintaining high levels of motivation, engagement, and commitment from the PI, coordinator, and all other individuals involved in research is extremely important for a successful project. This means that you will need to maintain the engagement of each individual separately as well as the whole team. Bringing back this focus and attention can sometimes be a big challenge for CRAs, sponsors or CROs. Seeing how this problem is so common in the research community and how many people are constantly struggling with this question, weve decided to help you reach your best potential by showing you how to increase and maintain your teams motivation and engagement in your research.
Maintaining high levels of motivation and commitment of your clinical research team from TrialJoin
]]> 212 5 https://cdn.slidesharecdn.com/ss_thumbnails/37zhfqkgtvadprdecybn-signature-0fa0f127e3905a0d73ad5be81cf7d236502dd161c06191da7c3aab1b40d1b1fe-poli-170510103320-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Increasing the quality of clinical research: best ways to solve the most common inefficiencies /slideshow/increasing-the-quality-of-clinical-research-best-ways-to-solve-the-most-common-inefficiencies-75847153/75847153 onkkypebtfhi8ecd7ms0-signature-925c64252c07fc0c2b520f03237ed6854a1292d6b2f36de7582dcdb2322a70e1-poli-170510103029
Like many other businesses, clinical research also has its imperfections and inefficiencies. Clinical research involves many different parties: research sites, sponsors, CROs, PIs, CRAs, CRCs, patient recruitment agencies, etc. All of these parties play a significant role in the clinical research field. As clinical research gets bigger and more evolved day by day, so does the need to fix the faulty areas. With the constant growing number of trials, the research industry urgently needs help! ]]>
Like many other businesses, clinical research also has its imperfections and inefficiencies. Clinical research involves many different parties: research sites, sponsors, CROs, PIs, CRAs, CRCs, patient recruitment agencies, etc. All of these parties play a significant role in the clinical research field. As clinical research gets bigger and more evolved day by day, so does the need to fix the faulty areas. With the constant growing number of trials, the research industry urgently needs help! ]]> Wed, 10 May 2017 10:30:29 GMT /slideshow/increasing-the-quality-of-clinical-research-best-ways-to-solve-the-most-common-inefficiencies-75847153/75847153 TrialJoin@slideshare.net(TrialJoin) Increasing the quality of clinical research: best ways to solve the most common inefficiencies TrialJoin Like many other businesses, clinical research also has its imperfections and inefficiencies. Clinical research involves many different parties: research sites, sponsors, CROs, PIs, CRAs, CRCs, patient recruitment agencies, etc. All of these parties play a significant role in the clinical research field. As clinical research gets bigger and more evolved day by day, so does the need to fix the faulty areas. With the constant growing number of trials, the research industry urgently needs help! <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/onkkypebtfhi8ecd7ms0-signature-925c64252c07fc0c2b520f03237ed6854a1292d6b2f36de7582dcdb2322a70e1-poli-170510103029-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Like many other businesses, clinical research also has its imperfections and inefficiencies. Clinical research involves many different parties: research sites, sponsors, CROs, PIs, CRAs, CRCs, patient recruitment agencies, etc. All of these parties play a significant role in the clinical research field. As clinical research gets bigger and more evolved day by day, so does the need to fix the faulty areas. With the constant growing number of trials, the research industry urgently needs help!
Increasing the quality of clinical research: best ways to solve the most common inefficiencies from TrialJoin
]]> 152 6 https://cdn.slidesharecdn.com/ss_thumbnails/onkkypebtfhi8ecd7ms0-signature-925c64252c07fc0c2b520f03237ed6854a1292d6b2f36de7582dcdb2322a70e1-poli-170510103029-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Helpful information for sponsors: How to best spend your resources and avoid unnecessary waste? /slideshow/helpful-information-for-sponsors-how-to-best-spend-your-resources-and-avoid-unnecessary-waste-75789812/75789812 4rznedvsx2vvbtmz0vja-signature-1e3e9207f7c0ec889805856303eeb8eb3f69c028d3ebfd9eca5e339acc2bc474-poli-170508191033
Conducting a clinical trial as a business is equally important as it is expensive. Saying that this business is important is actually an understatement, since clinical research is the stepping stone of all medical advancements and new treatments that can help millions of people worldwide. However, the importance of this business is proportional to its cost! Clinical research is a costly business, and this can be best seen in pharma sponsors. Pharmaceutical companies are usually the ones that sponsor researches for new treatments. Estimations for 2013 show us that the average cost per patient in a clinical trial (all phases, all therapeutic areas) is $36,500. When we take this average number as an example and consider the number of sites a sponsor might need for the study, plus the necessary number of recruited patients (considering that most will not meet the criteria), we can see why this business is so expensive. ]]>
Conducting a clinical trial as a business is equally important as it is expensive. Saying that this business is important is actually an understatement, since clinical research is the stepping stone of all medical advancements and new treatments that can help millions of people worldwide. However, the importance of this business is proportional to its cost! Clinical research is a costly business, and this can be best seen in pharma sponsors. Pharmaceutical companies are usually the ones that sponsor researches for new treatments. Estimations for 2013 show us that the average cost per patient in a clinical trial (all phases, all therapeutic areas) is $36,500. When we take this average number as an example and consider the number of sites a sponsor might need for the study, plus the necessary number of recruited patients (considering that most will not meet the criteria), we can see why this business is so expensive. ]]> Mon, 08 May 2017 19:10:33 GMT /slideshow/helpful-information-for-sponsors-how-to-best-spend-your-resources-and-avoid-unnecessary-waste-75789812/75789812 TrialJoin@slideshare.net(TrialJoin) Helpful information for sponsors: How to best spend your resources and avoid unnecessary waste? TrialJoin Conducting a clinical trial as a business is equally important as it is expensive. Saying that this business is important is actually an understatement, since clinical research is the stepping stone of all medical advancements and new treatments that can help millions of people worldwide. However, the importance of this business is proportional to its cost! Clinical research is a costly business, and this can be best seen in pharma sponsors. Pharmaceutical companies are usually the ones that sponsor researches for new treatments. Estimations for 2013 show us that the average cost per patient in a clinical trial (all phases, all therapeutic areas) is $36,500. When we take this average number as an example and consider the number of sites a sponsor might need for the study, plus the necessary number of recruited patients (considering that most will not meet the criteria), we can see why this business is so expensive. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/4rznedvsx2vvbtmz0vja-signature-1e3e9207f7c0ec889805856303eeb8eb3f69c028d3ebfd9eca5e339acc2bc474-poli-170508191033-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Conducting a clinical trial as a business is equally important as it is expensive. Saying that this business is important is actually an understatement, since clinical research is the stepping stone of all medical advancements and new treatments that can help millions of people worldwide. However, the importance of this business is proportional to its cost! Clinical research is a costly business, and this can be best seen in pharma sponsors. Pharmaceutical companies are usually the ones that sponsor researches for new treatments. Estimations for 2013 show us that the average cost per patient in a clinical trial (all phases, all therapeutic areas) is $36,500. When we take this average number as an example and consider the number of sites a sponsor might need for the study, plus the necessary number of recruited patients (considering that most will not meet the criteria), we can see why this business is so expensive.
Helpful information for sponsors: How to best spend your resources and avoid unnecessary waste? from TrialJoin
]]> 169 3 https://cdn.slidesharecdn.com/ss_thumbnails/4rznedvsx2vvbtmz0vja-signature-1e3e9207f7c0ec889805856303eeb8eb3f69c028d3ebfd9eca5e339acc2bc474-poli-170508191033-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 https://cdn.slidesharecdn.com/profile-photo-TrialJoin-48x48.jpg?cb=1523907707 trialjoin.com https://cdn.slidesharecdn.com/ss_thumbnails/pwr11bxftf2je5yydtyh-signature-e886e8bb1fb45d964c5cb5ddc8d81a473bc1ce55b312edea44e5dddfa7800b5c-poli-170920045828-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/what-to-do-when-there-are-adverse-events-and-serious-adverse-events/79963554 What to Do When There ... https://cdn.slidesharecdn.com/ss_thumbnails/hzzq5ekgs42r9xf56v2d-signature-e886e8bb1fb45d964c5cb5ddc8d81a473bc1ce55b312edea44e5dddfa7800b5c-poli-170920045828-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/new-drug-application-how-to-speed-up-fda-approval-79963553/79963553 New Drug Application -... https://cdn.slidesharecdn.com/ss_thumbnails/ai8ftfarkenonnikwdvw-signature-80ec0337a0b9f4cc73ce2714df731ea15327ff0c0758749c342f7e44ec3a190c-poli-170920044626-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/negotiating-clinical-research-budgets-most-commonly-neglected-items-79963282/79963282 Negotiating Clinical R...