Can a Small Swiss Software Company Help Sponsors & CROs Better Manage the Protocol Deviation Process?

Can a Small Swiss Software Company Help Sponsors & CROs Better Manager the Protocol Deviation Process

In 2019, TrialSite reported on the Protocol Deviation Problem, in which these incidents cost the industry hundreds of millions of dollars per year, if not more, not to mention the lower quality and other ripple effects when changes are made to the protocol. A Switzerland-based company called Ethical GmbH, a software venture providing personalized software for clinical research committee management (e.g. IRBs and ethics committees), recently announced a new tool to purportedly “simplify the protocol deviation (PD) assessment and management process.” Called eDeviation®, the tool affords sponsors, CROs, and EC/IRBs to oversee, manage, and track all PDs, access and assess in a blinded and unblinded way, and track all of their operations and changes all in one web-based repository. This small venture, a spinoff of a boutique Italian information technology system integrator, develops software tools and offers consulting to help sponsors and CROs improve clinical research outcomes.

TrialSite breaks down this vendor, the overall tool suite, and this latest offering.

What is a protocol deviation?

As the vendor rightly shares, protocol deviations include changes, divergences, or de...

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