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Risk-Based Monitoring

by Medical Director
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Risk-based Monitoring (RBM) is a lean approach to clinical trial monitoring driven by the current ICH E6(R2) Guideline for Good Clinical Practice. The purpose of risk-based monitoring is to help clinical research organizations predict and manage risk at an early stage, so that monitoring resources can be prioritized based on risk and need rather than the traditional 100% SDV approach. A well-implemented risk-based monitoring process should result in significant data quality, patient safety and monitoring cost benefits, and ultimately reduce time to market. Combining risk-based and centralized monitoring enables subject-level surveillance and improves patient safety. Targeted site support enhances CRA efficiency. And the combination yields measurable improvements in outcomes.

Identify study quality and patient safety issues earlier

Predictive analytics, artificial intelligence, and machine learning are enabling more precise decision making in clinical monitoring. See how centralized clinical monitoring from BBMCT can enhance study quality, add efficiency, and improve patient safety.

Mitigate risk, improve study quality

Clinical monitoring can account for up to 60% of study costs. BBMCT ‘s clinical monitoring solutions integrate technology, data, analytics, and expert knowledge to create flexible, customized solutions that can reduce the cost of trial oversight by up to 35% – all while improving operations. 

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British BioMedicine Clinical Trials (BBMCT) 

Execution – The BBMCT 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 BBMCT 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: BBMCT 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

More data, fewer issues

BBMCT’s Risk-Based Monitoring (RBM) is proven to drive faster access to high quality data. With predictive and advanced analytics, you can identify and address issues earlier, creating efficiencies and improving safety for patients. Additional benefits include

  • In-depth, subject-level data to ensure medical congruency
  • Consolidated data on a single, automated platform
  • Demonstrated effectiveness for nearly all therapeutic areas and phases

Experience Delivers Results

  • Therapeutic, operational and regulatory expertise: Risks can arise at any stage of a study from many quadrants; BBMCT 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.
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British BioMedicine Clinical Trials (BBMCT) 

Centralized meets risk-based

It takes both experience and technology to effectively maximize risk-based monitoring. Our centrally located clinical monitors continuously review and analyze data, including a subject-level review process, to deliver insights that identify and mitigate risks across sites and patients as well as the study itself.

Automation drives excellence

BBMCT’s centralized monitoring platform powers a more efficient approach to risk management by using automated workflows, resulting in 

  • Detailed transparency to trial status
  • Key risk indicator and trigger management
  • Enhanced data flow for increased compliance

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