Maximizing Site Readiness for ICH E6(R3)
The ICH E6(R3) guideline redefines expectations for clinical trial sites, emphasizing proactive planning, data accuracy, and risk monitoring to enhance participant safety and trial efficiency. Download our presentation for practical insights and strategies to ensure compliance and strengthen collaboration.
Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy
The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management.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.
ACDM Features RBQM Shift from ClinOps to Data Science
Speaking at the 2nd Annual ACDM Symposium on RBQM, our CEO highlighted how RBQM has evolved from supporting Clinical Operations to becoming an integrated approach to data management.
Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease
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.