With the ICH E6(R3) guideline set for approval by October 2024, sponsors face new requirements in risk management, RBQM, and data integrity. Stay compliant and efficient by downloading our free infographic that highlights the key differences between ICH E6(R2) and E6(R3).
The Importance of First-in-Human (FIH) Trials First-in-Human (FIH) clinical trials, also known as Phase 1 trials, are a pivotal stage in drug development. Conducted with a small group of healthy volunteers, these studies mark the first testing of a new drug in humans. [...]
In the ever-evolving landscape of clinical trial risk management, effective communication between various systems is crucial for streamlined operations and regulatory compliance. The MyRBQM Portal, a leading risk-based quality management (RBQM) tool, introduces advanced API integration capabilities tailored to clinical operations and risk management [...]
FDA Guidance: A Risk-Based Approach to Monitoring of Clinical Investigations (Q&A) The FDA has published a new guidance document titled "A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry," outlining their expectations for sponsors and clinical investigators regarding [...]
Explore the benefits of Cyntegrity's Subject Profiles module, a tool designed for clinical researchers to review and monitor subject data with ease. This innovative solution ensures data privacy, research integrity, and effective risk management in clinical trials.
Cyntegrity's latest version of the MyRBQM® Portal, V7.3.1, brings several improvements to enhance your user experience. With a focus on data security, the release includes security updates that predict and prepare for potential breaches.
MyRBQM Portal V7.0.0 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.
MyRBQM Portal V6.9.0 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.
