Bottleneck #4: Database Lock and Submission

Database lock is when Agile Clinical Development shines in full — when every strategic decision and adaption you make culminates into one tight, complete package, usually within a day or two of receiving the trial’s last CRF.

Where typical database locks can take months to complete while backlogged data is reconciled, our Agile approach lets us clean and verify as we go, so that you can submit to the FDA and get the results you depend on as quickly as possible.

Featured Case Study: Phase II, Oncology

Challenge: Three months prior to the study’s scheduled end date, our sponsor needed to accelerate database lock by six weeks, a goal that had been dismissed as unfeasible by one the industry’s largest CROs, with whom they were conducting a sister study.

Solution: With the aggressive new goal in mind, our team compiled an exact snapshot of the study’s current status, which we weighed against the site and monitor performance trends assembled throughout the course of the trial. Armed with a precise analysis of the requirements needed to lock the database early, we meticulously re-allocated our monitoring resources and worked closely with sites in pursuit of the accelerated timeline.

Results: Our sponsor’s trial not only met its new database lock deadline — it actually locked three days early — nearly two months ahead of the original schedule.

For more information on how we can help you with your next trial, please contact us.