Veranex Risk Based Monitoring (RBM) services deliver business insight by applying structured problem solving to your data. This approach combines “Industry Standard Concepts” & “Technologies” to focus on three crucial areas:

  1. Central Monitoring Core Activities
  2. Clinical Monitor/ Remote CRA Support &
  3. Web Analytics Training Support

Central Monitoring Core Activities

A chief tenet of RBM is to evaluate your data and identify ‘risks’ using a remote, ‘centralized’ process rather than sending monitors to all your study sites. These processes employ statistical analyses to identify data problems, issues with sites (e.g., potential training issues that show up in the data, or data integrity) and trends (e.g., increasing protocol deviation rates) and to focus on the most meaningful measurements for a study.

Key Veranex Deliverables for Central Monitoring

  • Development of a Central Monitoring Plan
    • Based on Protocol review, eCRF review, Identification of Review categories & expert input
    • Document to include definition of risks indicators, risk categories (low, medium, high), monitoring approaches, action plans, roles/responsibilities/training, and communication pathway
  • Development of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs)/Study Level Thresholds
    • Identification of KRIs, Validation of KRIs & Biostats review of KRIs
    • Identification of QTLs/Study Level Thresholds
  • Apply tools and techniques to identify data trends & patterns, such as
    • Use of Visualization Approaches/Dashboards to provide study specific metrics and graphic illustrations
    • Use of Statistical modelling to evaluate critical data
  • Use Predictive, Machine Learning modelling to Time Series Forecasting
    • Calculate forecast of subjects at risk to proactively alert study personnel if triggers are exceeded
  • Preparation of Study Insight Report (SIR) /Monitoring Insight Report (MIR) (Development of training manuals- SIR/ MIR Training Manuals)
    • Interpretation of data and extraction of insights
      • SIR is a comprehensive report used to identify & categorize the study level risks in addition to the risk trend analysis
      • MIR is a site level report with identified issues and remediation tips
    • Training manuals developed and distributed based on study specific SIR/MIR reporting
    • Documentation released on a periodic basis to stakeholders
  • Report identified issues to PM/Sponsor/CRA
    • Compiled report of actionable issues for the PM/Sponsor/CRA
  • eTMF review
    • Filing of documentation for end of study audit

Clinical Monitor/ Remote CRA Support

There may still a need for on-site monitoring with centrally monitored trials, but the use of technology can make this a more focused and efficient endeavour than the traditional 100% SDV monitoring. With information from the monitoring reports, on-site reviews can respond to identified issues in a targeted manner.  For decentralized trials, where the need for patients to travel to specific study sites is reduced or eliminated, the use of technology for monitoring activities may also take the place of on-site visits for SDV.

Key Veranex Deliverables for On-Site and Remote Monitoring

  • Real time review of ‘targeted’ data for Source Data Verification & Review
    • Remote monitoring technology includes scanning source documents into a secure portal and the use of electronic source documents
    • Clinical monitors may cross verify the eDC data with eSource, performing 100% SDV remotely
  • 100% review of Informed Consent Forms (ICFs) for all subjects screened for the study
    • Including eConsent for decentralized trials
  • Review of protocol deviations and violations
    • Important for both on-site monitoring as well as remote monitoring where adherence to study visits may be more difficult in a decentralized trial
  • Train investigator site personnel to ensure understanding of the protocol and all protocol-required procedures.
    • Includes training in any and all remote technologies (e.g., ePROs)
  • Resolution of monitoring queries at every visit when possible.
    • Follow-up will be conducted, as needed, for any monitoring queries that remain outstanding at the conclusion of the visit.
  • Evaluate any IRB responses or questions to make sure they have been answered and/or followed up
  • Issuing queries where required into the platform
  • Follow up meetings with investigator to discuss findings/ observations

Web Analytics Training Support

Success with new Processes and Technology relies on good training and support! Veranex supports your organization to ensure questions get answered quickly, your users gain confidence, and you get the best possible results.

  • Training & First Layer of user support
    •  Navigation for Web Analytics
      • A walk-through session is provided to sponsors & study team
      • Aid in understanding different features available under different review categories
  • Work as Point of Contact (POC) to provide support post training
    • A dedicated resource to support users with questions after their training is important for the success of new technologies
  • Gather Requirements i.e., Navigation issues, Report downloads, etc.
    • Change requests to the technology for improvements and error reports