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Investigator Grants

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Working with Countries that are Difficult to Budget and Negotiate - Ying Jiang January 10, 2012

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Investigator Grants

  1. 1. Working with Countries that are Difficult to Budget and Negotiate (Investigator Grants)Ying Jiang, TTCDr. Alan Braverman, Independent ConsultantDr. Mitchell Katz, PurdueDr. Peter Carberry, Astellas January 10, 2012 | Philadelphia, PA
  2. 2. Countries of Interest• Poland• Brazil• Russia• Argentina• China• India• Japan
  3. 3. Question #1• Do you budget centrally for your global investigator budgets?
  4. 4. Question #2• Do you negotiate all of the investigator agreements or do you outsource it to CROs?
  5. 5. Question #3• How do you budget for emerging countries or countries that you have less experience with?
  6. 6. Question #4• How do you gather market intelligence? Country specific requirements and etc. • Are you prepared for to pay for ancillary items such as concomitant meds or even things like IV tubing or IV bags which may be considered a ‘given’ here?
  7. 7. Question #5• How do you ensure FMV and ensure your budgets stay competitive? • Do you have benchmarks?
  8. 8. Question #6• Multiple parties agreements: how do you dealwith the timing of CTA vs MOH/Ethics • For example: Poland needs a fully executed CTA to accompany the submission.
  9. 9. Question #7• Timelines: do the lower per patient costsmake up for the extended start-up times insome of these countries?
  10. 10. Thank You For Your Participation!TTC Corporate Headquarters TTC European4548 Market Street HeadquartersSuite M-20 136 Delaware RoadPhiladelphia, PA 19139 London, W9 2LL UK(215) 243-4103 (Tel) 44 (0)7792 145 831 (Tel)(215) 895-4001 (Fax) 44 (0)2086 584 033 (Fax) Visit our website @ www.ttc-llc.com