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Strategic outsourcing of clinical trials: An analysis of the Sponsor-CRO relationship with focus on growing markets of Asia. Presented by Dr. A.P.Netraranjn, PhD
Content ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reasons of outsourcing R&D: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Financial Aspect of strategic outsourcing  ,[object Object],[object Object]
Role of a CRO ,[object Object],[object Object]
Benefits of using a CRO ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Possible disadvantages of using a CRO ,[object Object],[object Object]
Services provided by CRO ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Increased technological expertise by CROs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Types of Sponsor-CRO relationship Licensing sponsor can earn revenue from a drug which it would not have developed of its own. CRO can have large profit if the drug is approved. CRO conducts drug research for its own products. Drug licensing Sponsor benefits from the value-added service. For eg Medidata solutions to various Sponsors; Covance’s access to Qualyst’s B-CLEAR system in 2006 for the  in vitro  assessment and  in vivo  prediction of critical pharmacokinetic properties. CRO enhances their relationship with the clients; may be able to bill for additional services. CRO offers a third party developed technology to clients. Technology partnership Sponsor pays lower upfront cost for developmental tasks performed by the CRO.For example, Quintiles entered into risk-sharing relationships in October 2009 with Eisai for Phase II Onco trials. CRO can have more than average profit if project is successful. CRO shares risk and reward with Sponsor on project-by-project basis. Risk sharing Sponsor can select vendors based on specific skills who are each expert in their domain. CRO obtains work which otherwise it may not have. Sponsor selects CROs on basis of specific capabilities. Functional service providers Sponsor reduces time to evaluate a vendor; obtains more favourable pricing from CROs. A close working relationship with CRO.For example, in 2001, Solvay Pharmaceuticals developed preferred provider relationship with Quintiles. Obtains more business from  Sponsor; save the bidding costs. Sponsor directs business to selected short listed CROs Preferred vendors Benefit to Sponsor Benefit to CRO Description Type
India & China: Emerging destinations for outsourcing clinical trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical trial scenario in India ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical trial scenario in China ,[object Object],[object Object],[object Object],[object Object],[object Object]
Government initiative for Clinical trails in China: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Factors responsible for concern to conduct clinical trials in China ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CRO presence in China ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
  Thank you ,[object Object]

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Strategic R&D Outsourcing

  • 1. Strategic outsourcing of clinical trials: An analysis of the Sponsor-CRO relationship with focus on growing markets of Asia. Presented by Dr. A.P.Netraranjn, PhD
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  • 10. Types of Sponsor-CRO relationship Licensing sponsor can earn revenue from a drug which it would not have developed of its own. CRO can have large profit if the drug is approved. CRO conducts drug research for its own products. Drug licensing Sponsor benefits from the value-added service. For eg Medidata solutions to various Sponsors; Covance’s access to Qualyst’s B-CLEAR system in 2006 for the in vitro assessment and in vivo prediction of critical pharmacokinetic properties. CRO enhances their relationship with the clients; may be able to bill for additional services. CRO offers a third party developed technology to clients. Technology partnership Sponsor pays lower upfront cost for developmental tasks performed by the CRO.For example, Quintiles entered into risk-sharing relationships in October 2009 with Eisai for Phase II Onco trials. CRO can have more than average profit if project is successful. CRO shares risk and reward with Sponsor on project-by-project basis. Risk sharing Sponsor can select vendors based on specific skills who are each expert in their domain. CRO obtains work which otherwise it may not have. Sponsor selects CROs on basis of specific capabilities. Functional service providers Sponsor reduces time to evaluate a vendor; obtains more favourable pricing from CROs. A close working relationship with CRO.For example, in 2001, Solvay Pharmaceuticals developed preferred provider relationship with Quintiles. Obtains more business from Sponsor; save the bidding costs. Sponsor directs business to selected short listed CROs Preferred vendors Benefit to Sponsor Benefit to CRO Description Type
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