Life Science Leader Magazine Supplements

CRO Leadership Awards 2013

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The role of clinical compliance within sponsor companies is relatively new, and it will ultimately be a critical one. loop so the sponsor is involved in sanctioning changes to the frequency and intensity of monitoring as it occurs. WHAT TO WATCH OUT FOR The process can be complicated by several factors, the first of which is to be mindful of how the CRO proposes the budget and scope. Research sites with infrastructure and highly skilled staff are crucial to fully realize the cost savings, but they are often not identified as such when the project budget is initially defined. The gulf between many sponsors and CROs having an open dialogue built on trust may prevent a collaborative approach that is essential to defining the budget because there are many variables that can give the vendors concern about scope issues once the project begins. I recognize there are companies out there trying a risk-based approach, and I applaud them for their willing- ness to update their procedures. But there won���t be widespread adoption until lessons learned by those who���ve tried it can be shared publicly to demonstrate how well it works to appease those who are too nervous to take the plunge. Risk-based monitoring is not a panacea and not a one-size-fitsall solution. However, CRAs can and should be teachers, problem solvers, and compliance managers, not data point verifiers and box checkers. INDUSTRY LEADER Industry Leader Goodbye to administrative burdens. Hello to technologyenabled study startup and grant payments. By leveraging our focused investments and expertise ��� including our proprietary CFS InSite��� Platform ��� you always have access to the most advanced resources. �� Unparalleled Visibility �� Scalable, Standardized Processes �� Sunshine Compliant Ask the Experts at CFS Clinical US Headquarters: (888) 650-1860 In the UK: 0131 202 6178 www.CFSClinical.com/LifeScienceLeader The CRO Leadership Awards 2013 33

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