ICH E6 (R3): Take A Holistic & Automated Approach To Defining, Protecting, And Monitoring Critical To Quality Factors

Experience peace of mind for sponsors and empower end-users with a seamless technological solution to systematically track Critical to Quality (CtQ) Factors throughout a study, eliminating the complexities of spreadsheets, disjointed systems, and manual tracking. Our fully integrated modular platform offers comprehensive tracking of CtQ Factors' lineage, starting from the ingestion of source data. This enables project teams to continuously monitor the completeness, integrity, and quality of CtQ Factors at the study, site, and patient levels throughout the entire trial.

By establishing a link between study risks, risk controls, and CtQ Factors within the platform, project teams gain a targeted dimension to prioritize data reviews and identify trends in real-time. Moreover, CtQ Factors remain prominently featured in all data review workflows, ensuring that medical monitors, data managers, and cross-functional reviewers stay attuned to the significance of their reviews.

Uncover how this approach ensures timely actions and escalations when needed, fostering a streamlined and proactive approach to trial management.