The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management. Combined with RBQM principles, sponsors can streamline trials, enhance safety, and align with regulations.
Clinical trial participants have the right to access their personal data, a principle emphasized in the ICH E6(R3) guidelines. Sponsors must ensure transparency and provide participants with their data in a clear and accessible format. Our Subject Profiles tool offers a streamlined solution, enabling sponsors to generate comprehensive reports efficiently, thereby meeting regulatory requirements and enhancing participant trust.
This article explains why sponsors should adopt RBQM principles early in trial planning, supported by regulatory recommendations, and highlights the benefits of early implementation compared to addressing these elements later in the monitoring plan—or not at all.
AI-Enhanced Subject Profiles Elevating Medical Monitoring in Clinical Trials Unified Subject Data Access All critical patient insights in one place AI-Powered Data Quality & Risk Detection Proactively identify data anomalies and risks Customizable Monitoring Flexibility [...]
This opinion piece by Keith Dorricott, MBB, addresses the challenges faced by the clinical trial industry in implementing QTLs and KRIs as required by ICH E6(R2). The article explores why KRIs have been easier to adopt than QTLs and wonders if the specific guidance provided by ICH E6(R2) is partly responsible.
