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