Several mini-reports were produced from the comprehensive START II research report, including this one, focusing on areas of particular interest for stakeholders requiring further analysis of the research data.
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 this mini-report include:
- Centralized function regional split
- Average overall cycle times: Dedicated vs. non-dedicated functional group
- Repeat site cycle times for centralized vs. localized (non-dedicated) functions
- New site cycle times for centralized vs. localized functions
- Does having a centralized funcation impact the percentage of sites not activated
- And more...
The research was funded by goBalto, the industry leader in study startup.