Contract Research Organizations
prior regulatory inspections, recently completed NDA (new drug application) or other submissions, whereby the CRO had primary responsibility for executing a pivotal Phase 3 trial. Conduct a tai- lored audit to address sponsor learnings from the review. Once an ongoing relationship with a CRO is established, a phased-in/ phased-out approach should be employed. For example, the sponsor should initially review CRO regulatory packages prior to submission. This may lead to iterative interactions, which can eventually be phased out as sponsor and CRO achieve alignment.
WHAT TRICKS OR RESOURCES HAVE YOU FOUND TO BE HIGHLY USEFUL IN THE CRO SELECTION PROCESS?
Peter Carberry, Astellas Pharma US: We have a two-step pro- cess that enables us to first identify an initial set of competent vendors through a request for information (RFI) process and then proceed to final selection through the RFP. Blinded to the vendors, we score the RFP responses against a comprehensive set of criteria that can be measured, at least semiquantitatively, and then weight appropriately. The scores are combined to give us a final result. The top candidate(s) are then invited to defend their proposals before we make a final decision.
DiBiaso: Regrettably, there are no tricks to alleviate the time and commitment required for a success- ful selection. The best approach is
invest-
ing time to educate the team so they understand their overall role
and primary goals. Functional representation needs to be sup- ported by their respective line leadership. This often requires significant alignment and input outside of the regular selection meetings. Executive leadership needs to provide clear and objec- tive guidance to the team. In some cases this can serve as an adjudicator for issues of disagreement, as well as to help the team when there is a challenge in reaching consensus.
WHAT ADVICE WOULD YOU GIVE TO THOSE INVOLVED IN THE CRO SELECTION PROCESS?
Carberry: It is really helpful for spon- sors to spend time defining and incorporating business require- ments and quantitative expecta- tions in the RFI documents prior to engaging in the
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