WCG, the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, today launched 360 Protocol Assessment™, an integrated, turn-key solution that addresses ICH E8 R1 expectations and improves clinical trial predictability by providing sponsors with an operational risk and feasibility assessment of the protocol through the lens of multi-functional stakeholders. This process decreases the number of required protocol amendments and highlights key risks and mitigations during the planning phase of the trial.
The 360 Protocol Assessment™ provides a holistic view of a sponsor’s protocol to ensure quality by design. WCG’s quality, operations, and diversity, equity and inclusion subject matter experts identify potential areas of risk in conjunction with its vast network of investigators, sites, and patient advocacy groups to ensure all key stakeholder input is received. The assessment incorporates strategies to proactively mitigate or manage the identified risks for faster clinical trial execution. Finally, through WCG Data Intelligence, the company provides deep insights into the competitive landscape of the protocol being reviewed that can be leveraged for site selection.
“Through this exciting new solution, WCG offers insight and pressure-test protocols for risk from the very beginning,” explains Christine Albano, general manager of Benchmarking and Analytics, WCG Research Solutions. “We can reduce uncertainty in study start-up activities, identify site readiness, flag any potential obstacles to patient recruitment, and take a more proactive approach to diversity and inclusion planning.”
“Protocol amendments have long been a challenge for the drug development industry given their impact on clinical trial timelines and costs,” adds Terri Moench, president, WCG Clinical Research Solutions. “According to a 2021 Tufts Center for the Study of Drug Development 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 $7 to $8 billion annually to implement protocol amendments. Making the investment in a protocol optimization solution like this is key to conducting faster, higher-quality clinical trials.”
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