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Maximizing 3 rd Party Vendor Relations For Medical Communications CBI 7 th Annual Forum on Dissemination of Scientific

Maximizing 3 rd Party Vendor Relations For Medical Communications CBI 7 th Annual Forum on Dissemination of Scientific Information May 25, 2010. Evan Demestihas, MD, RPh: Chief Executive Officer The Medical Affairs Company Principal. Executive Management & Medical Director

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Maximizing 3 rd Party Vendor Relations For Medical Communications CBI 7 th Annual Forum on Dissemination of Scientific

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  1. Maximizing 3rd Party Vendor Relations For Medical Communications CBI 7th Annual Forum on Dissemination of Scientific Information May 25, 2010

  2. Evan Demestihas, MD, RPh: Chief Executive Officer The Medical Affairs Company Principal. Executive Management & Medical Director Founded Science Oriented Solutions (SOS) the industry’s first Contract Medical Organization 1997-2008 25-year pharmaceutical industry veteran Sandoz, BMS, Solvay

  3. GOAL Optimize the relationship with the outsourced vendor to meet effective medical communications through compliant strategies

  4. Outsourcing:Delivering Value Through Efficiencies • Capitalizes on heavy-lifting and expedient program implementation while limiting burden to organization • Provides greater versatility & enhanced flexibility addressing internal challenges • Optimizes headcount limitations • Mitigates financial risk • Utilizes internal resources more effectively • Expands infrastructure & resources • Engages strategic insight and focused expertise

  5. New company with no medical communications department presence • Established company with fully functional medical communications department

  6. Assessment Steps / Needs Analysis • Current department assessment • Expected workload impact • Expected available resources • Outsourcing considerations

  7. Company A • New Company • Medical Communications & MSL outsourced • Limited home office personnel

  8. Company B • New Company • Launch only support to handle increased volume • Only consumer calls triage to vendor

  9. Company C • Established Company – big pharma device division • Internal headcount constraints • Overflow only support directed by client

  10. Company D • Generics Company • Rapidly expanding portfolio • Adverse Event only capture & processing • Decided not to build internal expertise in this area

  11. Vendor Assessment & Selection • Finding the right vendors • Screening call • RFP process: standardize criteria

  12. Typical RFP • Project specifications • Company background & experience summary • List relevant companies supported • Number of new clients added in the last year including volume/services provided • Experience and education of the professional & non-professional staff • Are they FT or freelancers / consultants • Overview of the operation • New program set-up; SOPs; staffing methodology • Describe management and QA process • Service level reports • Technology; validated? • Representative work samples (reports, SOPs) • Timeline • Detailed budge • References

  13. Vendor Assessment & Selection • Finding the right vendors • Screening call • RFP process: standardize criteria • Vendor presentations • Reference check • Site visits

  14. Vendor Training • Technical training • Corporate policies and procedures

  15. Medical Information Standard Operating Procedures • Customer Call Center • Call Center Operations • After Hours Coverage • Emergency Procedures • Medical Information • Medical Information Operations • Adverse Drug Reporting • Product Complaint Procedures • Training • Training & Development • SOPs • SOP Revisions • SOP Deviations and Change Requests

  16. Vendor Training • Technical training • Corporate policies and procedures • Ongoing

  17. Vendor Monitoring • Communication channels • Site visits • Audits

  18. Hallmarks of a Good Vendor • Reachable • Understanding • Responsive • Flexible • Quality • Value

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