Life Science Leader Magazine Supplements

CRO Leadership Awards 2014

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2014 17 Innovative diagnostics and research solutions for discovery, clinic and bioprocess. Learn more at Achieve better models, candidates & markers with metabolomics. expertise, but it must be proven by achiev- ing approvals. Many of the metrics for trial execution will remain the same (e.g. recruitment tar- gets, enrollment by site, cost, data quality, etc.), while others will be more program- matic and strategic — metrics often used to assess an internal team's performance, such as trial outcome (primary, secondary, exploratory), timelines, efficiency, patient safety, and adherence to GCP. In your experience, what lessons have you witnessed being learned the hard way in executing clinical trials in an outsourced model, and what advice would you have on ways to avoid these hard lessons? First, various CROs are remarkably poor at costing out trials and preparing bids pertinent to your specific request. Bids for the same trial can vary dramati- cally between competing CROs due to a lack of understanding by the contracting people of what the RFP is actually asking. This can lead to selecting the wrong CRO based on the arbitrary nature of the bid- ding process. Another lesson I've wit- nessed includes selecting early indica- tions based on the ultimate commercial target without actually determining the right dose and testing the hypothesis that the therapeutic actually affects the patho- physiology relevant to the disease. The key advice here is to define and review the proposal in detail, drilling down to under- stand real costs, and defining the devel- opment strategy in a manner that builds success into the process. One final lesson I've seen is being tricked by the "experi- ence" of the CRO in conducting a given trial indication. It is only relevant if the experienced staff are on your team, not if they once worked for that CRO sometime in the past. Projects change constantly. I see a distinct difference between internally resourced studies and outsourced stud- ies in terms of how change is handled. Don't freak out over the resulting change orders; focus on managing the impact of the changes on the team, the investigators, and the patients. Change management has to be in every project leader's toolbox. Everyone knows that study amendments impact the cost and timelines, but if the quality of the study is maintained, you are still in business. Communication issues underlie many challenges that arise in an outsourced model. Lack of timely communication or failure to listen to legitimate requests from either party can seriously under- mine the relationship and introduce unnecessary delays or even compromise the outcome of the trial. Integration of the outsourced personnel into a cohesive team model, along with good up-front strategic planning, will help to mitigate many of these issues. Leadership on both sides can help by fostering a collaborative team environment. L 0 3 1 4 _ C R O _ R o u n d t a b l e _ F u t u r e 3 C . i n d d 6 0314_CRO_Roundtable_Future3C.indd 6 2 / 1 9 / 2 0 1 4 1 : 4 5 : 2 7 P M 2/19/2014 1:45:27 PM

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