IQVIA’s Innovative UAT Services
Independent UAT of IRT and eCOA services are necessary as many critical issues have been identified related to incorrect medications or dosages being assigned to subjects, during UAT.
Conflict of interest is eliminated by not allowing third party vendors (TPVs) to write their own test scripts for IRT and eCOA systems. We have found that TPVs sometimes write test scripts that skirt known system and/or programming issues – we document and report everything we find.
The cost of fixing defects while an IRT or eCOA system is in production can be significant. The system may have to be locked for days (or longer) to resolve missed issues. This can result in missed screening/enrollment opportunities and drug shipment or randomization assignments, possibly for ongoing trial subjects, leading to the trial potentially having to be paused or delayed, causing inconvenience to patients and investigative sites, as well as Sponsor goals.
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