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Perfecting Practices

Over the past decade, the focus on technology as a driver of performance improvement in clinical trials has been intense (1- 2). This is particularly true for study start-up, a widely recognised bottleneck encompassing the activities associated with site identification, feasibility assessment, selection, and activation required before the first patient can be enrolled in a study.

Practices intended to streamline study start-up timelines include the use of technology investments to expedite the collection of clinical data and to help sponsors/CROs better monitor clinical trial performance, but, despite many attempts at improvement within organisations, gains in end-to-end cycle time have not been made (3).

A comprehensive survey conducted by the Tufts Center for the Study of Drug Development determined that a mere 8% of sponsors and 14% of CROs are extremely satisfied with their study start-up processes (4). By comparison, approximately 40% are either somewhat or completely unsatisfied with those methods. Respondents reporting that they are extremely satisfied have cycle times 57.5% shorter than those claiming to be completely unsatisfied.

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Craig Morgan is a technology and life sciences management professional with more than 15 years of experience in the application of informatics and bioinformatics to drug discovery. He currently heads up the marketing and brand development functions at goBalto, working with sponsors, CROs, and sites to reduce cycle times and improve collaboration and oversight in clinical trials.
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