For nearly a decade, MANA RBM has designed, tested, and published the results of the tools and processes we have developed to enable clinical trials to be run remotely. The processes and tools tool we developed to perform remote science-driven study oversight is called the MANA Method.
Conducting trials remotely is much more than just using an EDC system. You need to be able to collect and remotely review all data and documents from the trial—all of the things that you asked a monitor to do onsite. The MANA Method is designed and tested to deliver this comprehensive approach.
The MANA Method includes everything needed to implement remote trial management and oversight, whether you are a small or large company. This includes SOPs, Work Instructions, templates, and all the other tools you need.
We made the MANA Method flexible. It works seamlessly with multiple, different technology systems. Some of our tools are specifically designed for small companies with small budgets, while others are more automated, which work well for large, global trials.
MANA RBM proprietary databases and custom reports allow team members to review a synthesis of data from a myriad of trial databases to provide a comprehensive picture of each subject, each site, region, and the trial as a whole. 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.
The MANA Method ‘s remote document management approach includes electronic Investigator Site Files (eISF) for collection of regulatory documents and certified copies of subject source documents from sites. This approach aligns with all regulatory guidance and applicable laws such as 21 CFR Part 11. The documents are seamlessly integrated with the eTMF, allowing for rapid remote review and audit readiness from anywhere in the world. oversight assures documents flow seamlessly from the eISF to the eTMF, saving time and space for study sites and for Sponsors
The MANA Method delivers a proactive, supportive experience for the research sites—helping them conduct the study correctly. Site SOPs to support adoption of the electronic platform are available. Immediate feedback on errors with a focus on critical data, processes, and comprehensive reports to help investigators better manage their research trials saves time and prevents systematic errors. This helps sites maintain protocol compliance and efficiently uses the clinical research sites' time to conduct the study.
MANA RBM's business model is different too. We are a clinical trials institute and research laboratory, dedicated to delivering tools that the pharma, biotech, and device industry can use to conduct more efficient and effective clinical trials remotely. We realized early on that a comprehensive technology infrastructure was critical to implementing the remote trial management with science-driven oversight and risk-based monitoring. To allow the widest, most cost- effective adoption, we designed our processes and specifications to configure existing software systems such as your standard EDC.
MANA RBM’s oversight model is also different. We use science-driven oversight. That means that we specifically design our systems to collect the information we need to assure that the critical protocol processes are completed correctly (correct selection of subjects, correct randomization process, correct dosing and investigational product management, correct safety assessments, and of course, correct collection of the primary (and key secondary endpoints). We call these the errors that matter (ETM).
Science driven oversight using the MANA Method includes identification of systematic errors. This is a critical activity because systematic errors in the critical aspects of study conduct listed above will have the greatest effect on trial integrity.
The final step in completing a full remote trial management and science-driven oversight approach, REACHERTM (patent pending), is being released in 2020. It automatically identifies errors that matter and systematic errors with notifications sent directly to you. REACHERTM does the heavy lifting by identifying errors that occur across the myriad of databases that are part of every trial and does not require you to check every system in your trial—the analysis comes to you directly without any action on your part. REACHERTM also provides a full quality management system for your trial.
MANA RBM 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.