Life Science Leader Magazine Supplements

CRO Leadership Awards 2012

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Contract Research Organizations having visibility with the CRO, as well as the ability to interact with the CRO's senior management. I like to determine if there is transparency and trust in the potential partnership, as I am entrusting the execution of my company's clinical assets to the CRO. Engagement by the CRO's senior management team helps to ensure that my company is getting the right attention and service. Tokars: In my mind, accessibility is not simply ensuring that the CRO staff assigned to your project is available for a tele- conference or meetings to present suggested solutions to project challenges, but instead, to be a true partner, CROs need to allow sponsors transparency into their thought pro- cesses and internal deliberations. Talking through the chal- lenges, the history, and potential future remedies with high-level experts, often not intimately involved in the day-to-day operations of the trial, provides a 360-degree review of the problem and often results in discovering the best solution. WHAT METRIC DO YOU USE TO ASSESS PRODUCTIVITY AND HOW DO YOU WEIGHT THIS WHEN COMPARING DIFFERENT SIZES OF CROs? DiBiaso: While productivity and overall efficiency are critical compo- nents, the high rate of variability across sponsors and CROs i n terms of their respective development and operations mod- els makes true industrywide comparisons difficult. Fixed-unit prices, as part of the bidding and contract process, provide some comparative assessments. Functional metrics, such as workload monitoring of average-site-visits-per-monitor, active protocols, and active sites are but a few of the useful metrics when evaluat- ing a CRO by service offerings. It is essential to understand your own resource utilization and effectiveness measures so you have a basis of comparison when CROs cite their own productivity metrics. Gowen: During the CRO selection process, we evaluate their standards for timelines, turnover rates, meeting usage, i.e. updates vs. real work. An evolving approach during the execu- tion of the study is using earned value (EV) analysis to assess productivity at a high level. Calculating EV creates a relationship between tasks, project costs, and schedule. This provides one objective way of evaluating project health. WHAT IS YOUR APPROACH TO EVALUATING CROs FOR REGULATORY COMPLIANCE? Gowen: We solicit the CRO's prior audit and inspection history and the outcomes of those audits/inspections. The CRO's SOPs may also be requested and reviewed to ensure they have adequate processes and standards in place so that, when properly executed, their team adheres to the usual and customary practices. A post- selection CRO audit may identify areas of increased risk for regula- tory compliance. In early phase studies, audits can more easily be performed prior to, or as part of, CRO selection. Vetticaden: Prior to selecting a CRO, evaluate its overall experi- ence, track record, depth of knowledge, qualifica- tions, and experience of regulatory person- nel. Supplement this with a review of

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