WCG has introduced an integrated solution to meet the ICH E8 R1 requirements and enhance clinical trial predictability.

Dubbed 360 Protocol Assessment, the solution has been designed to help sponsors with an operational risk and feasibility assessment of the protocol from the perspective of multi-functional stakeholders.

This reduces the number of protocol modifications, as well as indicating major risks and mitigations while planning the trial.

The tool also offers a comprehensive outlook of a sponsor’s trial protocol to enable quality by design.

WCG’s quality, operations, and diversity, as well as inclusion subject matter specialists along with investigators, sites and patient advocacy groups, identify possible risk areas to make sure that all major input from stakeholders is received.

The assessment features strategies to alleviate or manage the recognised risks to speed up the implementation of clinical trial.

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WCG Clinical Research Solutions president Terri Moench said: “Protocol amendments have long been a challenge for the drug development industry given their impact on clinical trial timelines and costs.

“According to a 2021 Tufts Center for the Study of Drug Development (CSDD) survey, nearly eight of 10 Phase II protocols and seven of 10 Phase III protocols have at least one substantial protocol amendment.

“Tufts CSDD estimates that sponsors are spending $7bn to $8bn annually to implement protocol amendments. Making the investment in a protocol optimisation solution like this a key to conducting faster, higher-quality clinical trials.”