Webinar Wrap-Up: Are CROs prepared for ICH E6 (R3)?

The intention of the International Council for Harmonisation (ICH) guidelines is to implement industry best practices — not to add additional burdens on clinical research staff. The most recent ICH E6 (R3) guidelines take a proactive stance towards improving the quality of clinical trials by introducing the concepts of quality by design (QbD) and critical thinking.

Making sure CROs are prepared for the next iteration of these regulations was the topic of a recent webinar sponsored by Oracle, featuring FHI Clinical’s own Rob King, Chief Operating Officer. Joining Rob was a roster of heavy hitters from other health organizations including Sheelagh Aird, Senior Director, Data Operations, PHASTAR; Christina Larsen, Director, Data Management Innovation, IQVIA; Kirill S. Soldatov, Director Process Improvement, PSI CRO; Erika Stevens, Principal Consultant from Recherche Transformation Rapide; and Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences.

Together, the panel strategized and discussed topics such as:

As a follow-up to the webinar, we asked Rob for his feedback on how the transactional nature of most business relationships in clinical research align with the proposed principles of ICH E6 or ICH E8.
According to Rob, ICH E8 stresses the importance of QbD, while ICH GCP E6 stipulates a well-documented contractual relationship between the sponsor, CROs and any subcontractors involved. However, both of these principles are best served by the development of strategic partnerships rather than a transactional relationship.

“QbD requires an upfront strategy and development that can be a shared activity under a partnership. Considering the time constraints we place on ourselves as an industry, transactional relationships are usually just-in-time agreements, which don’t allow for adequate planning,” commented Rob. “The onus for quality planning falls to the sponsor in most cases and may not include timely or comprehensive alignment by the CROs or subcontractors.”

To learn more about improving the quality of clinical trials through QbD and critical thinking strategies, watch the panel discussion here:

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