Establishing a Foundation for a Holistic RBQM Strategy
Ensuring patient safety is a critical objective across all clinical studies. To keep participants safe while keeping clinical trials on track, proactive monitoring and early detection of potential risk play key roles in the drug development process.
In recent years, the adoption of decentralized trial (DCT) models has created both opportunities and challenges in clinical development. While DCT models make trials more accessible and relieves patient burden, the volume and variety of study data collected adds greater complexity to trial management and monitoring processes.
One strategy to address the increasing complexity of trial monitoring is to evolve from Risk-based Monitoring (RBM) to Risk-based Quality Management (RBQM) — which is an end-to-end process that begins with protocol design and focuses on factors critical to quality throughout the trial lifecycle.
This white paper paper highlights why the industry is moving towards RBQM and how sponsors can build a scalable approach that protects trial participants, upholds study integrity, and increases operational efficiencies. Insights include:
- Drivers for RBQM adoption across clinical trials and the key elements of a risk-based approach
- How to get ahead of adoption challenges for a proactive approach to RBQM
- Benefits of taking a platform approach to enable a comprehensive RBQM strategy
To download the complete white paper and learn more, please fill out and submit the form on this page.