Risk Based Monitoring

Is your company still conducting on-site visits for every location at four to eight week intervals?


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.

What is Risk Based Monitoring?


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.


Who Can Benefit from Risk Based Monitoring Solutions?

We are typically engaged by Life Sciences professionals who are responsible for clinical development and information technology and who may be:

  • Responsible for maintenance of existing clinical systems
  • Consolidating systems for improved cost-effectiveness
  • Looking for ways to upgrade clinical trial management systems
  • Struggling with inefficient legacy systems, unable to integrate data in a meaningful way
  • Currently distributing resources uniformly across clinical sites, with many on-site visits

How We Help With Risk Based Monitoring

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.

Our Team Can Help You:

  • Leverage deep domain expertise to define gaps at program and protocol levels and create a risk management plan to address them
  • Design user-friendly dashboards to access integrated data across systems and sites, with both centralized and on-site access for flexibility
  • Maximize use of existing data assets to concentrate resources where most needed
  • Facilitate multi-level views of data by country, study or program for 360° perspective
  • Apply Change Management expertise through training modules for successful implementation

We bring together deep domain expertise in Life Sciences, Technology and Business Process Management to provide your company with the following benefits:

  • Ensure human subject safety
  • Better data quality and better use of data
  • Improved compliance with regulations
  • Reduced risk profiles by better ability to identify and address struggling clinical sites
  • Potential to reduce costs (may allow reduction in costly site visits by shifting to more reliance on offsite data monitoring)
  • Maximum value and ROI from monitoring efforts
  • Eliminate unnecessary site visits, making every visit more valuable
Need Help Finding the Right Solution?

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.

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