Our Approach to Monitoring
Risk Access Data
Targeted Risk-Based Monitoring: focuses on certain data points, certain sites, and certain events that may have the most risk and argues that validating them will produce the best value for the time and resources invested. These areas of focus are usually defined before the trial begins.
Triggered Risk-Based Monitoring: occurs when certain events (like a large number of adverse events, deviations to protocol) trigger detailed monitoring of particular endpoints or sites.
Remote monitoring: allows pharma and CROs to remotely conduct monitoring activities that were previously conducted on-site. This includes delivering documents to a CRA via email, fax, or snail mail to satisfy monitors’ queries and conduct source document verification.
Centralized monitoring: usually performed from the data collected via CRFs through electronic data capture (EDC). Allows the identification of outliers or trends that may need attention from the sponsor or CRO to identify and mitigate problems with the trial.
Risk access data:
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.
Develop the study plans: A cross-functional team comprised of players from the Sponsor organization and 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