Commonly Overlooked Issues in CRO Selection — and How to Address Them

Outside of a well-written protocol, no other item is as critical to the success of an outsourced clinical trial as choosing the right contract research organization (CRO) to manage it. All too often, trial sponsors express strong dissatisfaction with their CRO’s performance — yet many of the complaints could have been avoided with some simple upfront planning. Therefore, it is important to know the common mistakes that occur during CRO selection and how to deal with them.

Join this webinar with clinical outsourcing experts to discover how to successfully identify and address common errors and overlooked items in the CRO selection process, including:

• How to ensure that the CRO is the best match for the sponsor’s study objectives, timelines and budget — while delivering the highest-quality data
• Why cultural fit with the sponsor’s organization and project team is just as important as the CRO’s functional capabilities
• How to craft a bid request to avoid key project team substitutions, unnecessary costs or mid-study change-orders
• How to compare CRO budgets to ensure a true apples-to-apples comparison, even when they have different specifications, line items and levels of detail
• How to ensure the sponsor has full visibility into the study at all times — avoiding potential problems and fulfilling oversight responsibilities
• Why it’s critical to assess a CRO’s proven problem-solving abilities and backup plans — since all clinical trials run into unforeseen challenges at some point
• How to ensure the CRO’s clinical research associates (CRAs) interact well with the study site person and properly represent the sponsor

The featured speaker will also help with “reading past the sales pitch,” to equip the sponsor with the hard questions needed to uncover the “real” CRO. As just one example, the common statement “We offer all of the services you require” does not mean that their services are all the same quality — and in fact key services are often subcontracted to third-party vendors, adding complexity and risk to a study. This webinar will not only save a sponsor time and money, but also the trouble of having to deal with frustrating results.

Speaker

Gerald L. Klein, MD, Principal, MedSurgPI

Dr. Klein has been the founder of an SMO, CRO, Medical Writing Company, Analytic Lab, GI Biotherapeutics company and a physician consulting company. During his career, he has also served as a CEO, CMO, SVP (Quintiles/IQVIA), VP of Clinical Research and Medical Affairs, and member of the board of directors of several companies. Dr. Klein has been a Clinical Professor of Medicine and Pediatrics (Division of Basic and Applied Immunology) at the University of California, Irvine. Dr. Klein currently serves as a Principal of MedSurgPI, a physician consulting company. He is an associate editor, editorial board member and reviewer for several medical journals. Dr. Klein has published numerous peer reviewed journals, white papers, medical blogs, a textbook chapter and a book on bronchial asthma.

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