How Effective Are Clinical Study Startup Regulations?

By Craig Morgan, Oracle Health Sciences

An operational approach to protocol amendments helps ensure document completeness and lineage

The clinical trials sector is highly regulated, and justifiably so. Biopharmaceuticals that patients need and depend on must be safe and effective, which is why international regulations for Good Clinical Practice and an array of regulatory guidances zone in on how clinical trials should be conducted. But study startup (SSU), one of the most complicated and challenging parts of the clinical trials process, has surprisingly few guidelines. With limited regulations focused on this early part of clinical trial execution, what does it mean to be compliant? It is a fair question at a time when SSU execution is singled out as needing improvement, particularly with the growing number of costly protocol amendments. Fortunately, cloud-based technology built to aggregate data from multiple sources can provide transparency into SSU status in real time, making compliance more achievable.