We designed new, patent pending methodology to specifically meet Regulatory Guidance for Risk Based Monitoring (RBM), eSource, and ICHE6(R2) Good Clinical Practice; not retrofitted practices from older, trial oversight approaches.
MANA RBM’s complete RBM technology solution incorporates Medrio and JReview which can be deployed for trials the Sponsor decides to run alone or in conjunction with MANA RBM’s RBM monitoring services (e.g., subject monitoring, central trend analysis, data management).
MANA RBM’s technology tool suite includes a comprehensive quality management system used to manage clinical trials. We also offer a proprietary Site Tracker Analyzing Risk (STAR) for managing site risks.
We use direct data entry or eSource to allow immediate, remote oversight of subjects and rapid correction of errors. MANA RBM focuses on high risk data and processes (not just analysis data) identified through our proprietary Risk Assessment service with full traceability to our oversight tools. Our proprietary RBM reports, hosted in JReview, facilitate comprehensive oversight, better quality, and cost savings.
MANA RBM developed its remote trial management approach to ensure all data and documents were available remotely for immediate review. These proven processes, including SOPs, Work Instructions, and Training are provided to Sponsors that want to run trials internally. Instead of months of discussion and continuing costs, Sponsors launch Risk Based Monitoring and comply with ICHE6(R2) within weeks.
When you have problems implementing, managing, and incorporating RBM into a comprehensive quality management system, contact THE RBM CRO – MANA RBM
Based in Denver, Colorado. For more information, please visit our website at MANARBM.com.