RISK BASED & CENTRAL MONITORING(RBM)
Nova Bio Solutions’s risk based monitoring (RBM) services deliver business insight by applying structured problem solving to your data. This approach combines “Industry Standard Concepts” and “Technologies” to focus on three crucial areas:
- Central monitoring core activities
- Clinical monitor/remote CRA support
- Web analytics training support
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), trends (e.g., increasing protocol deviation rates), and to focus on the most meaningful measurements for a study.
There may still be a need for on-site monitoring with centrally monitored trials, but the use of technology can make this a more focused and efficient endeavor 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 Nova Bio Solutions Deliverables for On-Site and Remote Monitoring:
- Real time review of “targeted” data for source data verification and review
- 100% review of informed consent forms (ICFs) for all subjects screened for the study
- Review of protocol deviations and violations
- Train investigator site personnel to ensure understanding of the protocol and all protocol-required procedures
- Resolution of monitoring queries at every visit when possible
- 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. Nova Bio Solutions 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
- Work as point of contact (POC) to provide support post training
- Gather requirements (i.e., navigation issues, report downloads, etc.)