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Qps Ppt Presentation Sept 2009

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QPS Bio-Kinetic is a clinical research organization located in Springfield, Missouri that specializes in Phase I-IV clinical trials. It has a state-of-the-art facility with 240 beds across 5 study units. QPS Bio-Kinetic has over 15 years of experience conducting over 800 studies and has a dedicated, experienced staff with low turnover. Customers praise QPS Bio-Kinetic for its ability to reliably deliver high quality results on time and on budget.

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Qps Ppt Presentation Sept 2009
Introduction Quality Performance Service Quest Pharmaceutical Services and Bio-Kinetic Clinical Applications merged in early 2008 to form a company based on our mutual beliefs and practices on QUALITY, PERFORMANCE, and SERVICE.
Location Springfield, Missouri QPS Bio-Kinetic is located just 10 minutes from the Springfield-Branson Regional Airport
Quality Established Clinical Site Phase I IV Founded in 1994 Over 800 studies completed State-Of-The-Art Facility Five (5) Study Units on One Campus 240 Beds
Performance State-Of-The-Art Facility Separate secure pharmacy, retention area, examination rooms, dosing, and phlebotomy stations State-of-the-art refrigerated centrifuges High speed micro centrifuges
Performance State-Of-The-Art Facility Local clinical lab provides most results within 24 hours a day, 7 days a week Laminar flow hoods -70C and -20C freezers NIST calibrated temperature recording devices in refrigerators and freezers
Performance State-Of-The-Art Facility 24-hour security and monitoring systems Secure archive/ document storage FM 200 Gas fire suppression Automatic natural gas powered generators for power backup AEDs
Performance State-Of-The-Art Facility Fully equipped ECG and vital sign monitoring State-of-the-art self-interpreting electrocardiographs
Quality Clinical Staff Experience Four (4) Principle Investigators 損 Two (2) started in 1994 損 One (1) started in 2000 損 One (1) started 2005 Clinical Staff Experience 損 6+ years average length of employment 損 Less than 10% staff turnover rate 損 Leadership team averages over 15 years of experience managing clinical trials
Quality Audit Experience Twelve(12) FDA Audits 損 Ten (10) Clinical Sites 損 Two (2) IRBs 損 One 483 (September 2003) 損 16 Studies 損 August 2009
Service Population Specialties Healthy normal males Healthy normal females Healthy normal birth control free females Healthy postmenopausal women Healthy geriatric males and females Other select populations
Performance Rapid Recruitment 500,000 Metropolitan Area Population 40,000 College Student Population Over 3 hours from nearest Phase I units Large Database of High Quality Subjects 損 Less than 5% drop out rate 損 Over 20,000 registered subjects in database 損 Fill 80% of studies exclusively from database
Performance Rapid Recruitment Multi-tiered Outreach Effort 損 Direct Email & Mail Phone Calls 損 Internet Website Links from community websites Interviews
Performance Rapid Recruitment Multi-tiered Outreach Effort 損 Community Events Job Fair University Social Events Promotional Events Sponsorship 損 Mass Marketing Billboards & Buses TV & Radio Newspaper Ads 損 Referral Programs Participants Local Business
Quality Individualized Study Preparation Protocol Training 損 Initiation Visit 損 Protocol Review 損 Walk Through Meetings Dry Runs Protocol Training AE Preparation and Review Study Events Review 損 Weekly Staff Review Meeting Protocol Training GCP Training Review Study Preparation AE Preparation and Review 損 Custom Communication Plan
Service Administration Expertise: Oral Intravenous Intramuscular Intradermal Subcutaneous Buccal Transdermal cream, gel, patch Vaginal cream, gel, suppository Suppository Intranasal Intrauterine
Performance Study Integrity 損 Concise SOPs 損 Protocol Adaptable Processes 損 Continual Staff Training 損 On-Time Study Events 損 Accurate Sample Collection 損 Thorough Sample Reconciliation
Service Type of Study 2005 to 2009 QTC 14% BA 27% Vaccine QTC 5% Vaccine PD PD 4% Other Other 1% Steady State Steady State Food Effect 17% RDT BE 15% DDI Food BE Effect BA 10% DDI 5% RDT 2%
Performance Examples of Study Experience (between 2004 2009) 24 Vaccine Trials 損 1 Hepatitis B 損 1 Japanese Encephalitis 損 1 Yellow Fever 損 2 West Nile 損 4 Dengue Fever 損 5 Small Pox 損 10 Flu 41 Postmenopausal Studies 34 Geriatric Studies 19 Birth Control Studies 12 Cardiac Safety Studies
Performance Recent Examples of Performance Study 11708 損 1242 Subjects enrolled in 4 weeks Aged 40 to 90 80% over the age of 60 per protocol 損 16,160 Samples processed and shipped on time Study 11508 損 90 postmenopausal subjects recruited in 4 weeks 損 Conducted over holiday weekend on time 7 Studies in same compound 損 116 to 140 subjects each 損 All subjects na誰ve to compound 損 Returns out to 3 months 損 50/50 male/female 損 Single IM injection
Service Collaboration with Quintiles for TQTc Full service TQTc offering Ability to conduct large cohorts High throughput paperless system 24/7 monitoring by cardiologists ECG data management from initiation through submission to the FDA ECG Warehouse
Service QPS Bioanalysis Preclinical DMPK Clinical PK/PD Modeling Translational Medicine QPS Taiwan Quality You Expect Service You Trust Turnaround You Need
Service Commitment to Customer! Highly experienced staff works to obtain results quickly, on time and on budget Work with you to meet your objectives Minimize your costs Recruit and start your study fast and full We keep you updated every step of the way Your Success is Our Success!
Quality "At QPS Bio-Kinetic, you can expect the highest quality and reliable services for your Phase I studies. QPS Bio-Kinetic employs dedicated and experienced people to perform your studies. Sheela M. Associate Director, QA I have found [QPS] Bio-Kinetic to be a highly professional organization with the ability to be flexible and responsive to the needs of the clinical program. Nicholas P. Associate Director, Early Development QPS Bio-Kinetic has the most experience of any Phase I unit in the industry. They have highly-trained, long-term personnel who are not only technically expert but also understand the importance of your study. They have the equation for guaranteed success. I always recommend QPS Bio-Kinetic to my colleagues". Rick S. CEO
Quality Our company has placed studies at QPS Bio-Kinetic for over 10 years, including the key pharmacokinetic study assessing Drug X components, as well as many of our postmenopausal women, Drug Y pilot bioavailability studies, and all of our pivotal bioequivalence studies. One wouldn't normally think of Springfield, Missouri, as a major CRO site, but the types of subjects they continually enroll are just solid, middle-class citizens with excellent retention for a clinical study. For our pivotal Drug Y BE studies, we routinely enroll over 70 postmenopausal women subjects and no other site in this country or EU can enroll and dose them in one day, as can be done at QPS Bio-Kinetic. QPS Bio-Kinetic is planned as a site for all future Drug Y BE studies. Having served on the Drug Y team and been involved in many management presentations, there is simply no way we can make our timelines and meet our project objectives without using this site. Phil M. Assistant VP of Clinical Pharmacology
Quality When we look for clinical research sites, we prefer smaller organizations that understand the unique pressures of optimizing speed, quality and price we face as a small company. We demand they be trustworthy, can perform the protocol as directed, are able to communicate study progress and are focused on client service. I have worked with QPS Bio-Kinetic for many years, in particular for BE/BA, DDI and cardiac safety studies. Because of their experienced staff, training and detailed processes, I am confident I can count on qualified study participants, quality data and PK samples to be drawn on time. I trust QPS Bio-Kinetic to tell me when they dont have the capacity to perform my study according to my specifications or timeline. Based on their history of meeting my expectations and my trust in the QPS Bio-Kinetic staff, QPS Bio-Kinetic has become my first choice as a clinical site. Jim M. Senior Director, Clinical Development

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Qps Ppt Presentation Sept 2009

  • 2. Introduction Quality Performance Service Quest Pharmaceutical Services and Bio-Kinetic Clinical Applications merged in early 2008 to form a company based on our mutual beliefs and practices on QUALITY, PERFORMANCE, and SERVICE.
  • 3. Location Springfield, Missouri QPS Bio-Kinetic is located just 10 minutes from the Springfield-Branson Regional Airport
  • 4. Quality Established Clinical Site Phase I IV Founded in 1994 Over 800 studies completed State-Of-The-Art Facility Five (5) Study Units on One Campus 240 Beds
  • 5. Performance State-Of-The-Art Facility Separate secure pharmacy, retention area, examination rooms, dosing, and phlebotomy stations State-of-the-art refrigerated centrifuges High speed micro centrifuges
  • 6. Performance State-Of-The-Art Facility Local clinical lab provides most results within 24 hours a day, 7 days a week Laminar flow hoods -70C and -20C freezers NIST calibrated temperature recording devices in refrigerators and freezers
  • 7. Performance State-Of-The-Art Facility 24-hour security and monitoring systems Secure archive/ document storage FM 200 Gas fire suppression Automatic natural gas powered generators for power backup AEDs
  • 8. Performance State-Of-The-Art Facility Fully equipped ECG and vital sign monitoring State-of-the-art self-interpreting electrocardiographs
  • 9. Quality Clinical Staff Experience Four (4) Principle Investigators 損 Two (2) started in 1994 損 One (1) started in 2000 損 One (1) started 2005 Clinical Staff Experience 損 6+ years average length of employment 損 Less than 10% staff turnover rate 損 Leadership team averages over 15 years of experience managing clinical trials
  • 10. Quality Audit Experience Twelve(12) FDA Audits 損 Ten (10) Clinical Sites 損 Two (2) IRBs 損 One 483 (September 2003) 損 16 Studies 損 August 2009
  • 11. Service Population Specialties Healthy normal males Healthy normal females Healthy normal birth control free females Healthy postmenopausal women Healthy geriatric males and females Other select populations
  • 12. Performance Rapid Recruitment 500,000 Metropolitan Area Population 40,000 College Student Population Over 3 hours from nearest Phase I units Large Database of High Quality Subjects 損 Less than 5% drop out rate 損 Over 20,000 registered subjects in database 損 Fill 80% of studies exclusively from database
  • 13. Performance Rapid Recruitment Multi-tiered Outreach Effort 損 Direct Email & Mail Phone Calls 損 Internet Website Links from community websites Interviews
  • 14. Performance Rapid Recruitment Multi-tiered Outreach Effort 損 Community Events Job Fair University Social Events Promotional Events Sponsorship 損 Mass Marketing Billboards & Buses TV & Radio Newspaper Ads 損 Referral Programs Participants Local Business
  • 15. Quality Individualized Study Preparation Protocol Training 損 Initiation Visit 損 Protocol Review 損 Walk Through Meetings Dry Runs Protocol Training AE Preparation and Review Study Events Review 損 Weekly Staff Review Meeting Protocol Training GCP Training Review Study Preparation AE Preparation and Review 損 Custom Communication Plan
  • 16. Service Administration Expertise: Oral Intravenous Intramuscular Intradermal Subcutaneous Buccal Transdermal cream, gel, patch Vaginal cream, gel, suppository Suppository Intranasal Intrauterine
  • 17. Performance Study Integrity 損 Concise SOPs 損 Protocol Adaptable Processes 損 Continual Staff Training 損 On-Time Study Events 損 Accurate Sample Collection 損 Thorough Sample Reconciliation
  • 18. Service Type of Study 2005 to 2009 QTC 14% BA 27% Vaccine QTC 5% Vaccine PD PD 4% Other Other 1% Steady State Steady State Food Effect 17% RDT BE 15% DDI Food BE Effect BA 10% DDI 5% RDT 2%
  • 19. Performance Examples of Study Experience (between 2004 2009) 24 Vaccine Trials 損 1 Hepatitis B 損 1 Japanese Encephalitis 損 1 Yellow Fever 損 2 West Nile 損 4 Dengue Fever 損 5 Small Pox 損 10 Flu 41 Postmenopausal Studies 34 Geriatric Studies 19 Birth Control Studies 12 Cardiac Safety Studies
  • 20. Performance Recent Examples of Performance Study 11708 損 1242 Subjects enrolled in 4 weeks Aged 40 to 90 80% over the age of 60 per protocol 損 16,160 Samples processed and shipped on time Study 11508 損 90 postmenopausal subjects recruited in 4 weeks 損 Conducted over holiday weekend on time 7 Studies in same compound 損 116 to 140 subjects each 損 All subjects na誰ve to compound 損 Returns out to 3 months 損 50/50 male/female 損 Single IM injection
  • 21. Service Collaboration with Quintiles for TQTc Full service TQTc offering Ability to conduct large cohorts High throughput paperless system 24/7 monitoring by cardiologists ECG data management from initiation through submission to the FDA ECG Warehouse
  • 22. Service QPS Bioanalysis Preclinical DMPK Clinical PK/PD Modeling Translational Medicine QPS Taiwan Quality You Expect Service You Trust Turnaround You Need
  • 23. Service Commitment to Customer! Highly experienced staff works to obtain results quickly, on time and on budget Work with you to meet your objectives Minimize your costs Recruit and start your study fast and full We keep you updated every step of the way Your Success is Our Success!
  • 24. Quality "At QPS Bio-Kinetic, you can expect the highest quality and reliable services for your Phase I studies. QPS Bio-Kinetic employs dedicated and experienced people to perform your studies. Sheela M. Associate Director, QA I have found [QPS] Bio-Kinetic to be a highly professional organization with the ability to be flexible and responsive to the needs of the clinical program. Nicholas P. Associate Director, Early Development QPS Bio-Kinetic has the most experience of any Phase I unit in the industry. They have highly-trained, long-term personnel who are not only technically expert but also understand the importance of your study. They have the equation for guaranteed success. I always recommend QPS Bio-Kinetic to my colleagues". Rick S. CEO
  • 25. Quality Our company has placed studies at QPS Bio-Kinetic for over 10 years, including the key pharmacokinetic study assessing Drug X components, as well as many of our postmenopausal women, Drug Y pilot bioavailability studies, and all of our pivotal bioequivalence studies. One wouldn't normally think of Springfield, Missouri, as a major CRO site, but the types of subjects they continually enroll are just solid, middle-class citizens with excellent retention for a clinical study. For our pivotal Drug Y BE studies, we routinely enroll over 70 postmenopausal women subjects and no other site in this country or EU can enroll and dose them in one day, as can be done at QPS Bio-Kinetic. QPS Bio-Kinetic is planned as a site for all future Drug Y BE studies. Having served on the Drug Y team and been involved in many management presentations, there is simply no way we can make our timelines and meet our project objectives without using this site. Phil M. Assistant VP of Clinical Pharmacology
  • 26. Quality When we look for clinical research sites, we prefer smaller organizations that understand the unique pressures of optimizing speed, quality and price we face as a small company. We demand they be trustworthy, can perform the protocol as directed, are able to communicate study progress and are focused on client service. I have worked with QPS Bio-Kinetic for many years, in particular for BE/BA, DDI and cardiac safety studies. Because of their experienced staff, training and detailed processes, I am confident I can count on qualified study participants, quality data and PK samples to be drawn on time. I trust QPS Bio-Kinetic to tell me when they dont have the capacity to perform my study according to my specifications or timeline. Based on their history of meeting my expectations and my trust in the QPS Bio-Kinetic staff, QPS Bio-Kinetic has become my first choice as a clinical site. Jim M. Senior Director, Clinical Development