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Russian Article Business Briefings Apr 05

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Richard_Leach

Russian Clinical Trials (RCT) is a growing regional CRO located in St. Petersburg, Russia that focuses on patient recruitment and quality data by performing in-depth feasibility studies, using physician monitors, and pre-qualifying additional sites to ensure enrollment goals are met. RCT maintains a flat business model to control costs while prioritizing quality and has experienced continued growth through repeat business and referrals due to their expertise and regional focus providing confidence to clientele. RCT monitors understand investigator concerns and can address them proactively to add value and partnership to each clinical trial.

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Technology & Services Speed and Quality There can be no Compromise a report by Richard Leach Vice President, Business Development, Russian Clinical Trials, LLC For companies involved in clinical research, patient Although many of the studies they have worked on recruitment and quality of data are probably the two involve sites in St Petersburg and Moscow, they most discussed themes during team meetings. For also work with clinical sites in other cities across some project managers it is their mantra these two Russia, the Ukraine and Bulgaria. The table to the elements can determine the success or failure of a left provides population information for some of development programme. Though they are totally the most populous cities in the region. These cities separate in how teams deal with each issue, they are provide their population with large, centralised forever tied together; speed without quality is like a medical institutions dedicated to specific race car on a roundabout, and quality without speed therapeutic areas, with motivated investigators Richard Leach is Vice President is like a horse-drawn carriage on the autobahn. One practiced in clinical research. In addition, the and Head of Business Development for Russian Clinical Trials Global, a without the other can lead to frustration and prospective patients who are treated in these regional contract research aggravation or worse, failure. facilities are eager to have access to western organisation (CRO) located in St Petersburg, supporting clinical medicines and medical care available through research throughout Russia, the Table 1 clinical trials. The combination of a large Ukraine, and Bulgaria. Prior to centralised population base, motivated joining Russian Clinical Trials, Mr Leach was Director of Business Some of the Most Estimated investigators, and eager, compliant patients has Development for PharmaNet, Populated Cities Population made this region one of the worlds fastest growing responsible for developing corporate relationships with key Moscow 10,000,000 clinical research areas, providing consistent international accounts. Over his 15 St Petersburg 4,500,000 enrollment success. years in the pharmaceutical Kiev Ukraine 3,000,000 industry, he has had the pleasure of working with companies offering Novosibrisk 1,500,000 Qualified Sites and Quality Data international services as diverse as Ekaterinburg 1,500,000 centralised laboratory and Kharkov Ukraine 1,500,000 RCT has benefited significantly, due to the increased electrocardiogram (ECG) monitoring to regulatory support and project Sofia Bulgaria 1,200,000 interest in the area and because of their commitment management. Prior to his position All city populations have been rounded to the nearest 100,000 to quality and cost-effectiveness. In a world where at PharmaNet, Mr Leach held numerous positions with Covance many consider bigger to be better, RCT has Labs, Premier Research, and Recognising the inseparable characteristics of these maintained a flat business model, keeping overheads Quintiles Late Stage Development. two forces in research, many companies and to a minimum while keeping quality its number one project managers have looked to establish partners goal. By offering audit support for every trial and in countries where patient interest is high and the providing upfront, in-depth feasibility information as medical community is motivated and well a standard practice, they have successfully managed educated. An example of this approach is the their clients enrollment expectations while fulfilling continual growth of research in the EU countries their quality obligation. and the current trend toward development in Russia, India, South America and China. Each of Prior to every trial, RCT performs an in-depth these countries offer benefits in terms of patient feasibility study; collecting key information from the access and professional medical care. Only Russia, sites specific to the individual study. Information however, provides access to more than 144 million regarding therapeutic site experience, clinical trial prospective patients (over 14 million in both experience, competitive trials, International Moscow and St Petersburg alone), combined with Conference on Harmonisation of Technical a wealth of experienced investigators and a Requirements for Registration of Pharmaceuticals streamlined regulatory submission process. for Human Use Good Clinical Practice (ICH GCP) knowledge, electronic data capture (EDC) Enrollment experience, access, validation aspects of trial-specific equipment, and expected enrollment rates as they Russian Clinical Trials (RCT) is a growing relate to the trial, are collected and presented to the regional CRO located in St Petersburg Russia. client during the proposal process. If during study 1 BUSINESS BRIEFING: PHARMA OUTSOURCING 2005
Technology & Services start-up additional sites are needed, RCT is prepared address these concerns before they are verbalised, to address that need since they pre-qualify 20% more will be seen as a critical partner in the success of the sites then are needed for the trial, allowing for site, adding value to the programme as a whole. In flexibility and last-minute changes. addition, these monitors, due to their scientific background and experience, are better positioned Peer Monitoring to challenge CRF entries and have data corrected during the monitoring visit, saving both time The RCT process and project management model and effort. is focused on client-specific goals with an emphasis on quality. Over and above the process is the RCT continues to grow and expand as a result of experience and clinical knowledge of the repeat business and word-of-mouth referrals. Their individual monitor. Every project manager and expertise is exceptional and their regional focus instills monitor at RCT is a doctor that at one time or confidence within their client base. Their business another has treated patients and/or performed as an model was developed to keep costs under control, investigator. Having doctors as monitors in Russia while still providing their clients the professionalism is critical in establishing an atmosphere of trust and they deserve and the services they need most. RCT mutual respect. A monitor who understands the has the experience, flexibility and focus to keep their concerns of the investigators, and can work to clients happy long into the future. 2 BUSINESS BRIEFING: PHARMA OUTSOURCING 2005
General Information The recent growth in pharmaceutical development in the Russian Federation, Bulgaria, Romania and the Ukraine has attracted the attention of drug development companies all over the world. Pharmaceutical and Biotech companies along with numerous international clinical research organizations have seen the value and have invested heavily. Everyday new offices are opening and trials are being initiated. Though this growth can be attributed to many things from the globalization of research to increasingly friendly regulatory environments one key element continues to drive interest, Patient Availability. The Russian Federation, Bulgaria, Romania and the Ukraine represent a population in excess of 200 million people. In major cities like Moscow, St. Petersburg, Novosibirsk, Sofia, Kiev and Odessa there are numerous hospitals and scientific research centers that are highly-specialized offering hundreds of beds. Many of these centers are pathology specific and attract patients from the local area (over 70% of the population live in and around major population centers). City - Country Population Global Clinical Trials, LLC (GCT) is a Regional CRO with its headquarters located in Princeton, NJ and offices in Russia, Moscow Russia 10,000,000 Bulgaria, Romania and the Ukraine performing clinical research St. Petersburg - services across Eastern Europe. GCT is experienced supporting 4,500,000 Russia trials across all phases of research and therapeutic areas; working Kiev - Ukraine 3,000,000 with international clients from across the globe. Whether you are looking for full clinical support to include site selection, monitoring, Bucharest, Romania 2,100,000 project management, Regulatory, import/export, drug storage, and Sofia - Bulgaria 1,200,000 medical writing; or only interested in an individual service to All City populations have been rounded to the address an urgent need, you can count on GCT to handle your nearest 100,000 requirements professionally and completely. We offer a strong understanding of both local and international regulations as well as access to 1,000s of qualified sites in numerous therapeutic Church on the Blood. areas. The GCT data base identifies over 2,800 experienced sites St. Petersburg, Russia throughout the region by indication and experience. Our pre-qualification process includes a review of ICH/GCP as well as local law for each site, to determine if additional training is required. Our monitors and project managers are all certified clinicians experienced in clinical research. Their relationship with each of their sites is strong and based on mutual respect. As an organization, GCT maintains strong ongoing relationships with the investigators and officials in the Ministry of Health. These relationships help us to develop reliable feasibilities and stay abreast of the changes in governmental regulations and their impact on clinical research. Our expanded logistical services helps ensure smooth and timely receipt of study materials and can also coordinate the shipment and storage of laboratory and PK samples. As your In Country Advocate, GCT will represent your organization with the kind of professionalism and attention to detail you would expect from your own team, except with the regional knowledge and local experience that can only come from years of working within the Region. Please call us and discover the GCT Experience for yourself, you wont be disappointed. St. Petersburg, Russia Contact: Richard Leach Moscow, Russia Sofia, Bulgaria Phone: (609) 731-2225 Kiev, Ukraine Bucharest, Romania Princeton, USA
St. Petersburg, Russia Moscow, Russia Sofia, Bulgaria Kiev, Ukraine Bucharest, Romania Princeton, NJ USA Experience Across Multiple Therapeutic Areas CNS Oncology / Blood Disorders Alzheimers, Depression, Schizophrenia, Colon, Pancreatic, Prostate, and Breast Attention Deficit Disorder, Multiple Sclerosis, Cancers, Acute Myeloid Leukemia, Diabetic Neuropathic Pain Chemo Induced Nausea and Vomiting, Cardiovascular Ophthalmology Acute Peripheral Arterial Thrombosis, Hyper- Acute Macular Degeneration (WET and lipidemia, Congestive Heart Failure, Ischemia, DRY), Subfoveal Choroidal Myopia, Arteriosclerosis, Coronary Artery Disease Glaucoma, Diabetic Macular Edema Anti-Infectives Dermatology Community Acquired Pneumonia (CAP), AIDS ACNE, Psoriasis, Rosacea, Herpes HIV Induced Diarrhea, Hepatitis C, simplex Streptococcus pneumonia, Helicobacter pylori (H. pylori), Urinary Tract Infections Metabolic / Endocrinology Other Studies Type I and Type II Diabetes, Diabetic Foot Surgical Pain, Acute Viral Rhinitis, Ulcer, Rheumatoid Arthritis, Osteoporosis, Stomach Ulcers, Gastric Intestinal Gastroenterology, Diabetic Neuropathy Reflux Testimonials: Our organization didnt have experience working in this region of the world so our team was a little anxious. It wasnt long however before we realized our fears were unfounded. GCT handled everything professionally and completely. They expedited the regulatory process and handled the importation of study drug from beginning to end. GCT made our first experience in Russia a huge success. President, US Biotech This was our second time working with GCT and they impressed us even more the second time around. With the deadline looming for submission prior to summer holiday, GCT worked tirelessly to create the submission package and manage all the translations necessary for us to get approval on time. From that point on we knew we had a team that understood the value of time and could get the job done! Director, Clinical Operations, US Pharmaceutical Company The support GCT provided in helping us get started was incredible. We found the staff to be very customer friendly, and professional. Our project manager, a cardiologist himself, knew every detail about the protocol and the patient population. We found GCT dependable and extremely easy to work with. V.P. European Operations, Global CRO Phone: 609-731-2225 www.gctrials.com

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Russian Article Business Briefings Apr 05

  • 1. Technology & Services Speed and Quality There can be no Compromise a report by Richard Leach Vice President, Business Development, Russian Clinical Trials, LLC For companies involved in clinical research, patient Although many of the studies they have worked on recruitment and quality of data are probably the two involve sites in St Petersburg and Moscow, they most discussed themes during team meetings. For also work with clinical sites in other cities across some project managers it is their mantra these two Russia, the Ukraine and Bulgaria. The table to the elements can determine the success or failure of a left provides population information for some of development programme. Though they are totally the most populous cities in the region. These cities separate in how teams deal with each issue, they are provide their population with large, centralised forever tied together; speed without quality is like a medical institutions dedicated to specific race car on a roundabout, and quality without speed therapeutic areas, with motivated investigators Richard Leach is Vice President is like a horse-drawn carriage on the autobahn. One practiced in clinical research. In addition, the and Head of Business Development for Russian Clinical Trials Global, a without the other can lead to frustration and prospective patients who are treated in these regional contract research aggravation or worse, failure. facilities are eager to have access to western organisation (CRO) located in St Petersburg, supporting clinical medicines and medical care available through research throughout Russia, the Table 1 clinical trials. The combination of a large Ukraine, and Bulgaria. Prior to centralised population base, motivated joining Russian Clinical Trials, Mr Leach was Director of Business Some of the Most Estimated investigators, and eager, compliant patients has Development for PharmaNet, Populated Cities Population made this region one of the worlds fastest growing responsible for developing corporate relationships with key Moscow 10,000,000 clinical research areas, providing consistent international accounts. Over his 15 St Petersburg 4,500,000 enrollment success. years in the pharmaceutical Kiev Ukraine 3,000,000 industry, he has had the pleasure of working with companies offering Novosibrisk 1,500,000 Qualified Sites and Quality Data international services as diverse as Ekaterinburg 1,500,000 centralised laboratory and Kharkov Ukraine 1,500,000 RCT has benefited significantly, due to the increased electrocardiogram (ECG) monitoring to regulatory support and project Sofia Bulgaria 1,200,000 interest in the area and because of their commitment management. Prior to his position All city populations have been rounded to the nearest 100,000 to quality and cost-effectiveness. In a world where at PharmaNet, Mr Leach held numerous positions with Covance many consider bigger to be better, RCT has Labs, Premier Research, and Recognising the inseparable characteristics of these maintained a flat business model, keeping overheads Quintiles Late Stage Development. two forces in research, many companies and to a minimum while keeping quality its number one project managers have looked to establish partners goal. By offering audit support for every trial and in countries where patient interest is high and the providing upfront, in-depth feasibility information as medical community is motivated and well a standard practice, they have successfully managed educated. An example of this approach is the their clients enrollment expectations while fulfilling continual growth of research in the EU countries their quality obligation. and the current trend toward development in Russia, India, South America and China. Each of Prior to every trial, RCT performs an in-depth these countries offer benefits in terms of patient feasibility study; collecting key information from the access and professional medical care. Only Russia, sites specific to the individual study. Information however, provides access to more than 144 million regarding therapeutic site experience, clinical trial prospective patients (over 14 million in both experience, competitive trials, International Moscow and St Petersburg alone), combined with Conference on Harmonisation of Technical a wealth of experienced investigators and a Requirements for Registration of Pharmaceuticals streamlined regulatory submission process. for Human Use Good Clinical Practice (ICH GCP) knowledge, electronic data capture (EDC) Enrollment experience, access, validation aspects of trial-specific equipment, and expected enrollment rates as they Russian Clinical Trials (RCT) is a growing relate to the trial, are collected and presented to the regional CRO located in St Petersburg Russia. client during the proposal process. If during study 1 BUSINESS BRIEFING: PHARMA OUTSOURCING 2005
  • 2. Technology & Services start-up additional sites are needed, RCT is prepared address these concerns before they are verbalised, to address that need since they pre-qualify 20% more will be seen as a critical partner in the success of the sites then are needed for the trial, allowing for site, adding value to the programme as a whole. In flexibility and last-minute changes. addition, these monitors, due to their scientific background and experience, are better positioned Peer Monitoring to challenge CRF entries and have data corrected during the monitoring visit, saving both time The RCT process and project management model and effort. is focused on client-specific goals with an emphasis on quality. Over and above the process is the RCT continues to grow and expand as a result of experience and clinical knowledge of the repeat business and word-of-mouth referrals. Their individual monitor. Every project manager and expertise is exceptional and their regional focus instills monitor at RCT is a doctor that at one time or confidence within their client base. Their business another has treated patients and/or performed as an model was developed to keep costs under control, investigator. Having doctors as monitors in Russia while still providing their clients the professionalism is critical in establishing an atmosphere of trust and they deserve and the services they need most. RCT mutual respect. A monitor who understands the has the experience, flexibility and focus to keep their concerns of the investigators, and can work to clients happy long into the future. 2 BUSINESS BRIEFING: PHARMA OUTSOURCING 2005
  • 3. General Information The recent growth in pharmaceutical development in the Russian Federation, Bulgaria, Romania and the Ukraine has attracted the attention of drug development companies all over the world. Pharmaceutical and Biotech companies along with numerous international clinical research organizations have seen the value and have invested heavily. Everyday new offices are opening and trials are being initiated. Though this growth can be attributed to many things from the globalization of research to increasingly friendly regulatory environments one key element continues to drive interest, Patient Availability. The Russian Federation, Bulgaria, Romania and the Ukraine represent a population in excess of 200 million people. In major cities like Moscow, St. Petersburg, Novosibirsk, Sofia, Kiev and Odessa there are numerous hospitals and scientific research centers that are highly-specialized offering hundreds of beds. Many of these centers are pathology specific and attract patients from the local area (over 70% of the population live in and around major population centers). City - Country Population Global Clinical Trials, LLC (GCT) is a Regional CRO with its headquarters located in Princeton, NJ and offices in Russia, Moscow Russia 10,000,000 Bulgaria, Romania and the Ukraine performing clinical research St. Petersburg - services across Eastern Europe. GCT is experienced supporting 4,500,000 Russia trials across all phases of research and therapeutic areas; working Kiev - Ukraine 3,000,000 with international clients from across the globe. Whether you are looking for full clinical support to include site selection, monitoring, Bucharest, Romania 2,100,000 project management, Regulatory, import/export, drug storage, and Sofia - Bulgaria 1,200,000 medical writing; or only interested in an individual service to All City populations have been rounded to the address an urgent need, you can count on GCT to handle your nearest 100,000 requirements professionally and completely. We offer a strong understanding of both local and international regulations as well as access to 1,000s of qualified sites in numerous therapeutic Church on the Blood. areas. The GCT data base identifies over 2,800 experienced sites St. Petersburg, Russia throughout the region by indication and experience. Our pre-qualification process includes a review of ICH/GCP as well as local law for each site, to determine if additional training is required. Our monitors and project managers are all certified clinicians experienced in clinical research. Their relationship with each of their sites is strong and based on mutual respect. As an organization, GCT maintains strong ongoing relationships with the investigators and officials in the Ministry of Health. These relationships help us to develop reliable feasibilities and stay abreast of the changes in governmental regulations and their impact on clinical research. Our expanded logistical services helps ensure smooth and timely receipt of study materials and can also coordinate the shipment and storage of laboratory and PK samples. As your In Country Advocate, GCT will represent your organization with the kind of professionalism and attention to detail you would expect from your own team, except with the regional knowledge and local experience that can only come from years of working within the Region. Please call us and discover the GCT Experience for yourself, you wont be disappointed. St. Petersburg, Russia Contact: Richard Leach Moscow, Russia Sofia, Bulgaria Phone: (609) 731-2225 Kiev, Ukraine Bucharest, Romania Princeton, USA
  • 4. St. Petersburg, Russia Moscow, Russia Sofia, Bulgaria Kiev, Ukraine Bucharest, Romania Princeton, NJ USA Experience Across Multiple Therapeutic Areas CNS Oncology / Blood Disorders Alzheimers, Depression, Schizophrenia, Colon, Pancreatic, Prostate, and Breast Attention Deficit Disorder, Multiple Sclerosis, Cancers, Acute Myeloid Leukemia, Diabetic Neuropathic Pain Chemo Induced Nausea and Vomiting, Cardiovascular Ophthalmology Acute Peripheral Arterial Thrombosis, Hyper- Acute Macular Degeneration (WET and lipidemia, Congestive Heart Failure, Ischemia, DRY), Subfoveal Choroidal Myopia, Arteriosclerosis, Coronary Artery Disease Glaucoma, Diabetic Macular Edema Anti-Infectives Dermatology Community Acquired Pneumonia (CAP), AIDS ACNE, Psoriasis, Rosacea, Herpes HIV Induced Diarrhea, Hepatitis C, simplex Streptococcus pneumonia, Helicobacter pylori (H. pylori), Urinary Tract Infections Metabolic / Endocrinology Other Studies Type I and Type II Diabetes, Diabetic Foot Surgical Pain, Acute Viral Rhinitis, Ulcer, Rheumatoid Arthritis, Osteoporosis, Stomach Ulcers, Gastric Intestinal Gastroenterology, Diabetic Neuropathy Reflux Testimonials: Our organization didnt have experience working in this region of the world so our team was a little anxious. It wasnt long however before we realized our fears were unfounded. GCT handled everything professionally and completely. They expedited the regulatory process and handled the importation of study drug from beginning to end. GCT made our first experience in Russia a huge success. President, US Biotech This was our second time working with GCT and they impressed us even more the second time around. With the deadline looming for submission prior to summer holiday, GCT worked tirelessly to create the submission package and manage all the translations necessary for us to get approval on time. From that point on we knew we had a team that understood the value of time and could get the job done! Director, Clinical Operations, US Pharmaceutical Company The support GCT provided in helping us get started was incredible. We found the staff to be very customer friendly, and professional. Our project manager, a cardiologist himself, knew every detail about the protocol and the patient population. We found GCT dependable and extremely easy to work with. V.P. European Operations, Global CRO Phone: 609-731-2225 www.gctrials.com