As clinical trials become more complex and costly, it is more important than ever to ensure that the study’s randomization and trial supply management (RTSM) logic is fit-for-purpose and matches the protocol. No study sponsor can afford system errors that threaten patient safety, jeopardize study timelines, or call data integrity into question.
That’s what makes user acceptance testing (UAT) so vital. An effective UAT helps sponsors avoid costly errors and delays, and gain confidence that the software will perform as expected. An effective UAT also ensures you will be able to demonstrate the validation during an audit.
The question is: Who is best suited to conduct UAT for clinical trials? For many reasons, outsourcing UAT to a third-party provider is the most effective way to reduce jeopardizing your clinical trial, patients, and reputation.
How Study Sponsors Approach UAT
While every organization is unique, the sponsor company’s size tends to influence how it handles UAT.