This is part 1 on our conversation on optimizing clinical site selection and evaluation. In this episode Linda Peterson and Julie Sheidy provide some background on the process of site selection from both the sponsors or clinical research organizations (CROs) perspective and the site’s perspective. Key takeaways include: Site workload is important. Make sure the site has capacity for your study.Ensure the site has access to the patient population and that the population is willing to support the study.Make sure the site has the infrastructure to set run the study and identify any mismatches or pain points early.Establishing clear lines of communication and identifying roles and responsibilities early will make the evaluation process much faster.Set realistic expectations.Teaching is much more effective than telling. Take the time to help the site or the CRO understand the process or problem. Use checklists! 3:30 – What is the site selection process and what are sponsors looking for? 5:50 – How do you put together a site feasibility questionnaire and where do sponsors begin the selection process? 9:30 – What are the most rate-limiting steps of site selection? 14:30 – What happens if a site does not have the facilities or expertise you need to complete the study? Is it the sponsor’s responsibility or the site’s responsibility to secure that functionality or expertise? 16:25 – Recommendations for what to look for in a clinical site. How do sites evaluate studies they are bringing in? 19:00 – Why it is important to evaluate the community around the site during site selection and do sites search for studies? 20:00 – How do sites facilitate site selection and qualification? 22:00 – A protocol-based workload estimation tool. 24:30 – How do sponsors evaluate how busy sites are? Is it realistic for sponsors to try to evaluate sites workloads during site selection? 28:10 – Julie provides recommendations on how the sponsor or CRO can help with site selection from the site’s perspective. 32:30 – Tips for staying organized and productive during site selection, evaluation, and study startup. 35:00 – How can the sponsor motivate sites to move things forward? Abbreviations: CRO = Clinical Research Organization IRB = Institutional Review Board CRC = Clinical Research Coordinator CRA = Clinical Research Associate

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