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.
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.