A collaborative study by Tufts CSDD and CRIO uncovers a critical, understudied phase of study activation, and what sponsors, CROs, and sites can do about it.
Study start-up timelines are getting longer, not shorter. While the industry has invested heavily in contracting, site qualification, and IRB workflows, one significant bottleneck has gone largely unexamined: the process sites use to interpret protocols and build their source documents.
CRIO partnered with the Tufts Center for the Study of Drug Development to take a closer look. The result is a first-of-its-kind study surveying 209 investigative site professionals across site types, roles, and regions.
What the research covers:
- How long sites wait for the critical documents they need to start source prep (on average, nearly 6 weeks, and up to 20)
- Why cross-document inconsistencies create downstream risks for data quality and patient safety
- The real workload behind source preparation: 80%+ of sites report more than 21 hours for high-complexity studies
- Where source data is actually being captured today, and what that means for EHR-to-EDC integration
- What sites want from sponsors, CROs, and technology providers to improve the process