MANA RBM provides clinical trial conduct support specifically designed to meet the FDA and EMA Guidance on Risk Based Monitoring (RBM) and Electronic Source finalized in 2015 and to deliver all aspects of the ICH E6 (R2) GCP requirements effective July 2017. MANA RBM uses its extensive experience in Clinical Development to deliver unique, proprietary products and services Sponsor Companies or CROs can easily and flexibly implement.
The MANA Method for Remote Trial Management delivers rapid, comprehensive review that exceeds simply reviewing Case Report Forms remotely. MANA RBM proprietary databases and custom reports allow team members to review a synthesis of data that provides a comprehensive picture of each subject and a comparison of protocol-specific efficacy and safety data across all subjects at a site and across sites.
MANA RBM training programs helps monitors and data managers move beyond simply checking to confirm data was reviewed to understanding which data findings are critical and how to analyze the impact of the finding and evaluate its scope.
MANA RBM delivers a proactive, supportive experience for the research sites. We provide immediate feedback on errors with a focus on critical data, processes, and comprehensive reports to help investigators better manage their research trials.
Based in Denver, Colorado. For more information, please visit our website at MANARBM.com.