Clinical site initiation process remains lengthy and highly inefficient

New Tufts Center Report

During the past decade, site identification, site selection, and study start-up— collectively referred to as the study initiation process—have become priority improvement areas in the conduct of clinical trials. Despite implementation of new technology solutions and practices, the study initiation process remains highly inefficient with wide variation between companies.

This report summarizes key findings of a recent Tufts CSDD study, based on a global survey, the first to comprehensively benchmark site identification, site selection, and start-up cycle times for both repeat and new investigative sites for Phase II and III clinical studies. The findings indicate that the site initiation process has become increasingly challenging for sponsors and CROs looking to identify and engage more specialized investigators and patient sub-populations worldwide.

This article can be purchased through a subscription from the Center for the Study of Drug Development at Tufts University School of Medicine, Boston, USA.
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