Risk-Based Monitoring

Effectively Identify, Mitigate and Monitor Risk

Successful Risk-Based Monitoring (RBM) depends on an integrated approach to risk assessment and monitoring throughout the entire project lifecycle. Therefore, collaboration and communication are critical, and all parties must share an unwavering commitment to ensuring participant safety and data integrity.

Risk Based Monitoring

Execution – The Medpace Approach to RBM Includes:

  • Risk assessment: We conduct a holistic, cross-functional risk assessment at the study/program level and then take a deeper dive at the protocol and site levels
  • Identification of critical variables: Critical data is defined while considering issues such as the impact and likelihood of error, appropriate mitigation activities, and the degree to which potential errors would be detectable
  • Strategic execution:  A cross-functional team comprised of players from the Sponsor organization and Medpace craft tailored study plans, outlining expectations for full or targeted source data verification, site quality management, data trend review, on-site and centralized monitoring
  • Balance: Striking the appropriate balance between on-site and centralized monitoring activities, we execute a comprehensive approach to monitoring – continuously assessing results and risks, maintaining standards for patient safety and data quality, and adapting as necessary
  • Innovative technology and analytical capabilities: Medpace has developed and invested in the innovative technology, training and analytical tools to support RBM. Cross-functional coordination helps identify trends and initiate appropriate targeted monitoring activities, allowing us to demonstrate a superior ability to analyze data and identify potential or emerging critical quality and statistical risks

Experience Delivers Results

  • Therapeutic, operational and regulatory expertise: Risks can arise at any stage of a study from many quadrants; Medpace provides comprehensive cross-functional expertise to help you effectively identify, mitigate and monitor risk throughout the study duration
  • Strong site relationships: Partnering with a CRO with strong site alliances is always important, but the RBM paradigm raises the stakes. Both on-site and remote site communication play an equally important role in the monitoring process and require exceptionally strong site relationships based on ample training and trust