The three words that strike fear and frustration in clinical departments: Clinical Quality Assurance. “All they do is find nit-picky errors like a data correction that hasn’t been properly documented.”
Clinical trials often run for months or years. Personnel at the clinical site and Sponsor come and go. The documentation trail has to be the primary source of what occurred during the course of your trial.
Our CQA professionals are on your side. Led by a former FDA safety officer with over 30 years of experience directing global QA, they’re tough and assess what happened based upon the documentation. But their goal is the same as yours - that the documentation supports protocol compliance, relevant SOP, GCP adherence, and patient welfare ensuring the results will withstand regulatory scrutiny.
We have conducted site, sponsor, and vendor audits, inspection-readiness training, and fraud-detection training. Audits have been conducted during the course of the study, for-cause, upon completion, and even locked database and final study report audits.
Don’t lose sleep at night because you can’t control every aspect of the study. Give us a call to discuss your concerns, and how we can give you peace of mind.
Flexible. Scalable. Reliable. We’re your solution.