A Collaborative Approach to Risk Based Monitoring
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.
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 detectible
- Develop the study plans: A cross-functional team comprised of players from the Sponsor
organization and Medpace crafts a risk-based monitoring plan, outlining expectations for data review, on-site, and centralized monitoring
- Monitoring execution: Striking the appropriate balance between on-site and remote activities, we execute monitoring, while continuously assessing results and risks, and adapting the plan as necessary
The Medpace Difference for Risk Based Monitoring
Our Sponsors benefit from:
- 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 trusted relationships.
- Superior technology and analytical capabilities: Medpace has invested in the technology,
training and analytical tools to support RBM. Cross-functional
coordination helps identify trends and initiate appropriate targeted