Medidata RBQM – Your Path To Clinical Operations Excellence

Medidata RBQM (Risk-Based Quality Management) provides the technology and experience to transform your approach to clinical operations towards risk-based study execution models. Now you can continuously monitor data from anywhere, allowing you to innovate and optimize your approach to trial design, physical and virtual  interactions with sites, and holistic portfolio strategy. Medidata RBQM leverages our experience in data acquisition and aggregation to contextually surface real-time insights at the patient, study, and industry benchmark level, improving Clinical Operations decision making.

All the Medidata RBQM suite of solutions (Risk Management, Detect, Remote Source Review and Rave TSDV) work together to help you adhere to ICH E6 (R2) and ICH E8 (R1) recommendations for meeting RBQM requirements. Medidata RBQM is fully configurable and scalable, so you can confidently make adjustments and decide what the right clinical operations strategy is for your trial because you have the technology to support it.

Benefits of Medidata’s Risk-Based, Quality Approach to Clinical Operations

Plan for trial risks, move from insights to action, and foster intentional, high-value interactions with sites using Medidata RBQM.

• Enable trial virtualization
• Achieve real-time actionable insights
• Eliminate manual tracking and data reentry
• Reduce implementation and integration challenges