By Lou Pasquale, Director of eTMF Technologies, IQVIA
Validating the features and functionality of an eTMF is both required by regulators and crucial to optimizing the management of a clinical trial. User acceptance testing (UAT), the phase of software validation during which real-world users operate a platform to ensure it can perform as expected in various scenarios, can represent significant time and investment for vendors and sponsors. Traditionally, this testing is performed either through in-house testing or by way of a third-party vendor. Although each of these models can provide valuable insights into a technology’s usability, both can also serve to compound the burden for a UAT protocol as both trials and the technologies supporting them grow more complex.
Crowdsource UAT is a validation model that enables testing via real, external users. An approach most often seen in the larger tech space, crowdsource UAT can offer several potential advantages for the clinical trial industry – with access to more users, crowdsourcing can often result in faster testing, as well as more reliable flagging of issues and bugs. This, coupled with the advantages users themselves can experience through the in-system training offered by testing, can help position organizations for a more streamlined, comprehensive UAT and technology deployment. As part of a push to realize the benefits of crowdsource UAT for clinical studies, IQVIA has launched a crowdsourcing model by building a bespoke, vendor-managed crowdsource eTMF tenant for use in system upgrade cycles.