Remote Risk Based Monitoring
CRO Oversight and Central Monitoring Services
MANA RBM monitors provide central monitoring services for trials that have been contracted using traditional trial management approaches. This approach can also offer an initial foray into Risk-Based Monitoring. We complete a risk assessment,
design reports to allow oversight of critical data and processes, and deliver reports for sites and Sponsors on performance.
CRO oversight services allow Sponsors to have full visibility into all aspects of trial conduct, assuring complete oversight with documentation.CRO oversight works independently of ongoing trial conduct. It can be implemented at any time and using any EDC system, regardless of the study status. We identify issues that cannot be identified using traditional methods (SDV, SDR, Key Risk Indicators, Statistical modeling). You gain value (and insurance for your study) in every trial.
Our study-specific reports for CRO Oversight and Central Monitoring include:
- Subject Specific, proprietary tools such as the Subject Profile Analyzing Risk (SPAR), enabling rapid, focused review of critical data across cross-data sets and across time. We also develop additional study-specific reports based on trial
requirements. For instance, if the study requires ePRO assessments for efficacy, we have an entire suite of reports to evaluate every aspect of the issue—assuring your most important data is checked vigorously. If you have ever “lost”
a site due to poor data entry at a site that was not identified until after the study was closed, you know the importance of this type of review.
- Reports to evaluate site performance across sites. This allows us to identify systematic errors often missed using traditional review. In a recent trial, we found multiple data irregularities occurring across subjects
at a site. These errors were never identified earlier, despite traditional monitoring efforts.
- Site evaluation reports to evaluate site performance across many different aspects. These tools identify outlier sites and include both study-specific reports rather than simply generic reports.
- Operational reports to evaluate team performance to plans. This allows oversight on monitoring report frequency, issue and CAPA follow up, and deviations evaluation, to name a few.
We set up all technology and reporting systems for CROs or Sponsors interested in converting to Risk Based Monitoring and Remote Trial Management or we can provide full CRO services.
The MANA RBM team designs all technology systems to remotely conduct efficient management of all aspects of the trial. The proprietary tools we provide include:
- STAR (Site Tracker Analyzing Risk) database for clinical trial operations.
- This tool supports site selection, monitoring reports (including central monitoring, remote monitoring, onsite monitoring), management of IP, deviation collection, issues management including CAPAs, risk assessment, and medical review.
- Clinical database for direct data entry including subject source questions.
- Electronic Investigator Site Files (eISF) and electronic Trial Master Files (eTMF) including processes for converting paper documents to certified electronic source.
- Subject Profile Analyzing Risk (SPAR): custom multi-dataset visualization for subject review based on the protocol and risk assessment.
- Custom Reports for Site-specific status reports, central cross-site review, and reports to manage the trial with data merged across multiple databases.
The project team members complete both general and study specific training on the MANA Method for RBM and remote trial management.
MANA RBM’s CRO Services are competitively priced and deliver significantly more quality oversight of subject safety, critical efficacy measures, protocol compliance, investigational product management, and Good Clinical Practice than traditional