CHALLENGES IN GLOBAL
                  `

       CLINICAL DEVELOPMENT

                               Presented
          ...
Meeting Agenda
 – Tough times demand good decision making and efficient clinical
   development

 – Leveraging biometrics ...
• Case Studies



     TOUGH TIMES DEMAND GOOD
   DECISION MAKING AND EFFICIENT
       CLINICAL DEVELOPMENT


            ...
Tough Times > Smart Development
 – Decrease in Venture Capital investment
                                                ...
• Case Studies




     LEVERAGING BIOMETRICS TO
   OPTIMIZE CLINICAL DEVELOPMENT



                  ENSURING   ALL   GO...
EDC Systems and Risk Mitigation
• EDC is generally seen as a tool which:
    –   Collects data in ‘real time’
    –   Prov...
ATTENTION!
 The entire presentation is available to registered
                 attendees only!

   To view the rest of th...
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Leveraging Biometrics and Niche Global Expertise to Mitigate Risk, and Increase the Efficiency of Clinical Development Suleman Verjee, Ph.D., President and CEO, Versante International, LLC

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3rd Annual Challenges in Global Clinical Trials Conference, Jan. 28-29, 2010, San Diego, CA.

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Leveraging Biometrics and Niche Global Expertise to Mitigate Risk, and Increase the Efficiency of Clinical Development Suleman Verjee, Ph.D., President and CEO, Versante International, LLC

  1. 1. CHALLENGES IN GLOBAL ` CLINICAL DEVELOPMENT Presented January 28, 2010 ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET
  2. 2. Meeting Agenda – Tough times demand good decision making and efficient clinical development – Leveraging biometrics to optimize clinical development • EDC systems and risk mitigation • Overcoming Current Medical Practice Challenges by Leveraging Statistics • Experience can salvage a clinical program jeopardized by poor planning – Strategic Paradigm for Global Clinical Development by Emerging and Mid-Size Companies ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET
  3. 3. • Case Studies TOUGH TIMES DEMAND GOOD DECISION MAKING AND EFFICIENT CLINICAL DEVELOPMENT ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET
  4. 4. Tough Times > Smart Development – Decrease in Venture Capital investment “Venture – Patent expirations and potential loss of revenues Capital investment – Shorter development cycles are critical and fundraising – Strategic solutions to study challenges slowed – Successful study results considerably in 2009 and – Identify and harness market potential, capture the interest of Large Pharma and Venture Capital will continue in 2010.” – Respond to higher demands in risk management NVCA ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET
  5. 5. • Case Studies LEVERAGING BIOMETRICS TO OPTIMIZE CLINICAL DEVELOPMENT ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET
  6. 6. EDC Systems and Risk Mitigation • EDC is generally seen as a tool which: – Collects data in ‘real time’ – Provides cleaner data – Enables faster database locking – More expensive option compared to paper • Paper-based systems are problematic due to: – Meeting eligibility criteria ensure uniformity of subjects across study sites – Paper based systems cannot ensure that criteria have been met – Paper based systems allow for more protocol deviations – Allow for shipment of drug – IVRS or not – if entry criteria not met – Violation of an entry criterion could lead to unnecessary safety concerns ENSURING ALL GOOD DRUGS ARE EFFECTIVELY TAKEN TO MARKET
  7. 7. ATTENTION! The entire presentation is available to registered attendees only! To view the rest of this exciting presentation and many more! Please Register for the 3rd Annual Challenges in Global Clinical Trials Conference at www.gtcbio.com If you are already registered, please contact GTCbio for the full version.

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