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European Pharmaceutical Contractor

Room for Improvement



A presentation at the 1998 CRO Pricing and Contracts Agreements Conference focused on how pharmaceutical companies could improve their management of and relationships with CROs – from the perspective of the CRO. One member of the audience suggested that it would be a good idea to repeat the presentation in 10 years’ time and predicted that nothing would have changed. This article reports on the results of an interactive session led by Uwe Schneider, Global Head of Sourcing Management at Grünenthal, at the November 2011 Partnerships in Clinical Trials meeting, where the slides from the 1998 conference were presented, and the audience was asked to comment on each slide.

Method

The audience, which numbered about 100 (consisting mainly of sponsors), was provided with a hand-held voting tool on which one of four options (‘has greatly improved’, ‘has slightly improved’, ‘still the same challenges’ and ‘has become worse’) could be registered in confidence.

Results

The 1998 presentation focused on two key areas: CRO selection (including request for proposal, the decision making process and contract management); and cooperation (including study conduct and study closure). The first slide considered the request for proposal (RFP). The audience was then asked to give its opinion on whether the issues had improved, stayed the same or become worse.








Conclusion We should firstly be pleased that there is little opinion that things have got worse. But clearly there is much room for improvement, as perceived by both sponsors and CROs. We can draw lessons for sponsors as follows:

  • Outsourcing has become an even more complicated business
  • Project management experience is needed
  • The process will never become routine
  • Effort must be made on both sides
  • The CRO’s needs must be clearly understood
  • Open communication, commitment and trust is required
  • On a long-term basis outsourcing can only work as a partnership
We believe that the solution is simple: clinical research is a people business. Both CRO and sponsor (as well as investigator and patient) need to be motivated and, unless some of the diffi cult issues addressed 13 years ago are not resolved, better and faster clinical research will continue to be a challenge to all concerned.



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