Uniformly applying resources across clinical sites does not yield the best value. Risk Based Monitoring offers an opportunity to improve patient safety, efficiency and valid clinical trial outcomes while meeting critical regulatory compliance mandates.
If your organization is not integrating the data held in IVRS, EDC, CTMS and other systems to create a unified picture, they are missing an opportunity. Your company’s clinical data assets can feed into a custom dashboard, allowing it to be monitored from a centralized location and supplemented by more strategic (and potentially less frequent) site visits. Our Risk Based Monitoring model will deliver significantly improved value for your company’s efforts.
Risk Based Monitoring is a powerful, technology-based approach that maximizes the use of your company’s data, allowing you to make smarter decisions about where to focus resources. A risk-based approach is no less vigilant in its oversight of clinical studies. Centralized monitoring can better detect data anomalies, resulting in better data quality and integrity. Data discrepancies indicate more attention is needed. This allows more resources to be directed at the clinical sites that pose the highest risk for trial outcomes, data integrity and human subject protection.
We are typically engaged by Life Sciences professionals who are responsible for clinical development and information technology and who may be:
Our industry experts will guide you in making a strong business case for the benefits of Risk Based Monitoring, including regulatory compliance, better use of resources and greater value from your company’s investment.
We bring together deep domain expertise in Life Sciences, Technology and Business Process Management to provide your company with the following benefits:
Request a free consultation with one of Paragon's leading industry advisors to discuss the best solution for your organization's unique challenges and goals.