After a site has been selected, efficient study startup involves six major categories of activities, which require coordination. They include:
- Contract and budget negotiations
- Regulatory document management
- Training, including investigator meeting and SIV
- Approval by internal committees (when required)
- Receipt of necessary hardware, equipment and access to software
- Receipt of study supplies
Only when all of the above steps have been completed is a site ready to enroll. Yet, when there is a CRO managing the day-to-day activities associated with study start-up, how do you, as a sponsor, identify roadblocks in any of these steps? How do you, as a sponsor, determine what is causing them and verify how well the CRO is resolving them?
For each step, what are the required times for dedicated research sites, large clinical practice sites, small clinical practice sites, and academic sites? For each relevant geographic region? For your therapeutic area?
If you are interested in having these metrics for your next study startup, contact me.
Ross H. Weaver, PharmD, MBA