MANA RBM is dedicated to providing clinical trial conduct support specifically designed to meet 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.
Based in Denver, Colorado, MANA RBM has extensive experience in Clinical Development for Pharma, Biotech, and Device products—as Sponsors, CROs, and at the research site level. We deliver a unique, proprietary solution Sponsor Companies or CROs can easily and flexibly implement. In addition, MANA RBM can conduct your trials.
The MANA Method for Remote Trial Management delivers rapid, comprehensive review that exceeds simply reviewing Case Report Forms remotely. We are different than other Clinical Research Organizations. MANA RBM delivers focused processes to collect, manage, and analyze clinical, operational, and audit trail data as well as documents (i.e., subject source, site, and study related) 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. This includes all critical data identified during the Risk Assessment Process. Oversight is focused on those critical data elements and processes. The MANA Method includes review of data at the individual subject level, across subjects at a site, and across sites. Document review includes managing both the Trial Master File and Investigator Site Files remotely—assuring access and audit readiness.
Our monitor and data manager training was built on Blooms Taxonomy and proven education methods. MANA RBM uses these proprietary methods to help students move from remembering/understanding to the most important level for implementing and practicing the principles of RBM - applying, analyzing, and evaluating data. Our training program 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. Monitor training is separated into Site Monitor Training (which focuses on subject review and site support) and Central Monitor Training (focuses on trend analysis, statistical methodologies, and interpreting Site Performance).
MANA RBM delivers a proactive, supportive experience for the research sites—helping them conduct the study correctly. We provide immediate feedback on errors with a focus on critical data, processes, and comprehensive reports to help investigators better manage their research trials. This helps sites maintain protocol compliance and efficiently uses the clinical research sites' time to conduct the study. We strive to review data within one week of subject data entry, allowing sites to rapidly correct errors and minimize rework.
MANA RBM's business model is different too. Onsite monitoring visits are not our major revenue stream—unlike most Clinical Research Organizations (CROs). We focus onsite visits for training at the beginning of study start and as needed to support sites having issues that need to be supported. The remainder of the review is conducted remotely, aligning with the new regulatory requirements. Our unique, proprietary services and technology products enable us to manage all aspects of data and documents remotely.
is committed to efficiency and maximizing resources. We save greenhouse gasses by limiting travel and using electronic systems to eliminate overnight packages to obtain signatures. For a one year trial at 25 sites, we estimated conservatively that we saved 100,000 pages of paper (eTMF/eISF), eliminated 250 plane fares and/or car trips, and provided faster review, more comprehensive site support, and audit readiness than the traditional paper method of study conduct.