Tufts CSDD START II Research Report

Tufts CSDD START II Research Report
Tufts Center for the Study of Drug Development (CSDD) conducted an in-depth study on the clinical trial start-up process of biopharmaceutical and CRO companies in order to gather robust, quantitative insights into the selection process as a follow-up to the ground breaking 'START' (Start-up Time And Readiness Tracking) Study completed in 2012.

The new study, START II, focused on the end-to-end process of site identification through site initiation, on the challenges organizations are facing, and on new tools, technologies, and approaches being developed to overcome those challenges. The survey found wide variation between companies, indicating that company practices are highly inconsistent.

The study comprises data from 600 respondents from over 400 unique companies, 54% pharma and biotech 24% CROs with ~80% of respondents having more than 6 years in clinical development/clinical operations.

Areas examined in the research include:

  • Site selection practices and decision-making, study start up, and site feasibility
  • Implementation of specific tools and resources that impact cycle time, cost, and performance.
  • Factors contributing to poor site selection; improvements made to the site selection and start up processes.
  • Key performance metrics (e.g., cycle time) were gathered.