Are CROs Prepared For ICH E6 (R3)?

CROs have long been seen as the driving force behind the adoption of innovative clinical operations technology, but beyond just technology, opportunities for innovation are borne out of the realization that leading CROs are sitting on a wealth of actionable data and expertise, which can be leveraged into data-driven decision making on a large scale, from starting clinical trials through to execution.

ICH E6 (R3) reinforces this proactive stance and introduces the concepts of Quality by Design (QbD) and critical thinking. The guidance specifically calls for establishing a culture that supports critical thinking and open dialogue about quality that goes beyond reliance on tools and checklists.

Applying critical thinking during study startup is pivotal to improving study conduct overall. Proactive planning is essential to identifying what is needed to mitigate risk, ensure regulatory compliance, audit-readiness, and to avoid serious budget and timeline overages. As CROs fight to maintain market share and ensure long-term survival, those companies able to take these steps may be well-positioned to reap the rewards.

Key Learning Objectives:

• The intended purpose of ICH regulations—to implement industry best practices, and not to add additional burdens on clinical research staff
• What organizations stand to gain from adopting the updated guidelines, versus the compliance and other costs they’re likely to incur
• How by applying critical thinking to risk management, organizations can improve their operational efficiencies by minimizing duplicate quality-assurance steps
• Strategies for quick, relatively straightforward adoption of the new guidelines

Who Should Attend:

• Sponsor and CRO roles who are responsible for:
  • Site identification, feasibility assessment, selection, and activation
  • Clinical data management, collecting and evaluating trial metrics
  • Project management of studies, process optimization, and operational excellence