The Clinical Trials Unit: Defining, Staff Assessment and Scheduling Restructuring for Operational Efficiency

By FTI Consulting
Published: March 2016

By Erika Stevens, MA, Susan Autry, MBA, Christina Eberhart

Among the drivers for change is a decrease in research funding, a factor that triggers additional cost containment measures.1 Increased requirements imposed by regulatory authorities and Institutional Review Boards (IRBs), increases in the expertise required to plan and execute clinical studies and increased study site expenses are also significant factors. Changes in the structure of research organizations designed to decrease costs and improve efficiency are valuable mechanisms for coping with these factors.

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FTI Consulting Health Solutions’ Clinical Research and Compliance Practice—which includes some of the nation’s foremost authorities on research compliance and human research protections—is well positioned to assist research organizations in navigating and/or avoiding issues with research, enforcement and regulatory agencies. The Clinical Research and Compliance Practice provides a comprehensive array of healthcare related research and compliance support services.