During the configuration of an oncology study, TruLab identified a significant inconsistency between the protocol and lab manual. For this Day 8 visit, the protocol instructed collecting a single PK sample at pre-dose, while the lab manual and the associated kit had the collection at the 3-hour timepoint. This discrepancy highlighted a critical oversight that could have impacted the study’s findings and data integrity, and more importantly patient safety.

Resources

Privacy Policy

TruLab

110 N Corcoran Street

Durham, NC

27701