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International Clinical Trials

Choosing a Winning Model





How you approach implementing functional service provision (FSP) within your company has a direct effect on how successful those FSP teams will be. A ‘sustainable quality’ approach starts with picking the right model and navigating several areas of focus to ensure its success: planning, training, cultural fit, staff retention, technology, communication, agility, sponsor participation, performance indicators, expectations management, etc.

There are four basic models: uncapped time and materials (T&M), capped T&M, fixed fee, and ring-fenced/ full-time equivalents (FTEs) − each with pros and cons based on trial requirements and real-world experience.

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About the author


Jo Marshall is the Director of FSP and UK Country Manager for CROS NT. Jo entered the industry as a clinical data manager for Searle and held global data management roles for Pharmacia and Pfizer before moving to a specialist biometrics consultancy and contributing to the growth of that company first as Associate Director, then Managing Director until its sale to CROS NT in 2013. Since being at CROS, she has supported a variety of initiatives including commercial, quality, efficiency, and product development, as well as operational department management for the statistical programming team. She holds an MSc in Clinical Data Management, is the treasurer for the Association for Clinical Data Management (ACDM), and chaired the ACDM conference organising committee for a number of years.


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