There is a widespread movement towards configurable eClinical systems where companies take out-of-the-box software and meet specific requirements through configuration instead of custom coding. Benefits include faster implementations, higher quality implementations, streamlined updates and upgrades, lower total cost of ownership, and less reliance on vendors and software developers.

It’s important to educate clinical trial professionals on the differences and the impact to their trials. This directly impacts sponsor QA and validation teams as they begin to change their fundamental approach to system validation and User Acceptance Testing (UAT). The sponsor requirements for system validation (FDA reference) haven’t changed, but their approach has evolved.

To help companies understand this evolution, Poxy Clincal President Susan Vong spoke with Oracle to share her experience as the founder of IRT UAT Services company.