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Managing clinical trials outside of the US

Managing clinical trials outside of the US . John Potthoff , PhD President & CEO. Theorem Clinical Research. Global, full-service CRO 1000+ employees Planning and execution of clinical trials and regulatory applications Focused business units: Medical Device and Diagnostics

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Managing clinical trials outside of the US

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  1. Managing clinical trials outside of the US John Potthoff, PhD President & CEO

  2. Theorem Clinical Research • Global, full-service CRO • 1000+ employees • Planning and execution of clinical trials and regulatory applications • Focused business units: • Medical Device and Diagnostics • BioPharmaceutical Development • Clinical Analytics • Coverage of 44 countries

  3. Why conduct trials outside of the US?

  4. Where are trials conducted? Data as of 02 December 2012

  5. Actively Recruiting Studies (Data as of December 02, 2012)

  6. Focus on Asia Pacific Over 30% of new expenditures on healthcare worldwide are attributable to Asia.

  7. Why Asia for Clinical trials?

  8. Regulatory Authorities in Asia Pacific

  9. Asia Regulatory and Start-up Timelines Complicated and risk of delays *Note: China not to scale

  10. Data Collection in Asia Pacific *Some local trials conducted according to local minimal guidelines **Requires ability of CRO to process data in local languages

  11. Focus on China and India

  12. Drug Controller General of India (DCGI)

  13. Conclusions • Conducting clinical trials outside of the US is a necessary part of reaching a global audience • Conducting clinical trials outside of the US can be highly complex without local knowledge and experience • Several advantages to conducting trials outside of US: • Registration in multiple regions • Access to specific patient populations • Strategy to seek registration in cost advantaged locations

  14. John Potthoff, PhD President & CEO john.potthoff@theoremclinical.com 512-734-1715

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