The Industry funded IIT from the CRO perspective: Optimizing the interface between the industry and the Sponsor- Investigator. Presented by Ran Frenkel, CEO, Pharma Focus Israel at the First European Investigator Initiated Trials Conference in Barcelona, Spain.

1. The Industry Sponsored IIT from the CRO perspective: Optimizing the interface between the industry and the sponsor-investigator Ran Frenkel, RPh CEO PFC Pharma Focus Israel www.pharmafocus.co.il European Investigator Initiated Trials October 30-31, 2008 Barcelona Spain

4. The CR&D Position

5. The IIT Position IIT IIT

8. The “Leading Actors”

9. Industry Sponsored Trial

10. Industry-Sponsored IIT

11. The forces in IS-IIT

12. Marketing Authorization Holder (MAH)

27. Sponsor-Investigator

32. Industry Sponsored Trials Investigator Initiated Trial Sponsor Sponsor Investigator Project Director Project Director Medical Monitor/Advisor Medical Monitor/Advisor Pharmacovigilance Project Manager IMP Data Management & Biostatistics CRO Laboratory Project Manager Pharmacovigilance CRA Study Team Data Management & Biostatistics Patients Central Laboratory Study Sites Principal Investigator & Study Team Patients

33. Juggling the patchwork

40. Other facets of complexity

41. Contract Research Organization (CRO)

46. Contract setup of multicenter IIT Local CRO IMP Packaging & Labeling IMP Manufacturer Vendor A Vendor B CRO Site 3 Sponsor Investigator Site 1 Site 2 Site 4

47. Inv. Fees Legal, Insurance Inv. Meeting MON, MM, DM Site support IMP

55. Reaching the balance point