A Stepwise Approach To Data-driven Study Start-up

By Ashley Davidson and Brian Bialkowski

COVID-19 has highlighted the urgent need for greater efficiency and streamlined approaches in clinical drug development. Study start-up is an area that’s time and resource-intensive and has been predominantly managed through hundreds of spreadsheets and manual methods for the last 15+ years.

Study start-up is an area that could greatly benefit from automation, as start-up activities account for 61% of total clinical trial cycle times. With site initiation averaging 31.4 weeks and site contracts taking up to 13 weeks to execute, it’s not surprising that nearly 40% of sponsors and CROs are dissatisfied with current site initiation processes.