When Protocol Amendments Meet RTSM: From Headache To High-Performance

By Marc Weinberg, MBA, Senior Director of RTSM

Protocol amendments are a standard part of the clinical trial process, they can be disruptive but often necessary ^[1]. Regardless of the trial stage, therapeutic area, or industry and the rigor of protocol design, there are likely going to be adjustments made to the protocol – and that’s not a bad thing. However, your ability to minimize the disruption caused by mid-study changes will depend on the agility of your study’s partners and the technology in play. Manual solutions for tracking randomization and trial supply likely won’t be able to properly keep up with study designs or unanticipated changes. An RTSM solution is adaptive and flexible, and it can help you uncover the best ways to handle protocol amendments.