Innovation, redesigning processes to focus oversight on the high risk areas in clinical trials, and training are critical elements to achieve success in clinical research today. No process or technology is perfect. MANA RBM continually strives to improve processes and tools to fuel innovative solutions to your company’s clinical research needs as follows:
MANA RBM's innovative approaches align with the FDA, EMA, and ICH new guidance for overseeing the quality of trials. We have developed comprehensive processes, tools, and training materials to enable efficient adoption of the guidance.
Clinical trial operations require rigorous testing and innovation—just as our Sponsor companies innovate in its products, MANA RBM innovates its products and services continually for clinical research.
MANA RBM aggressively evaluates data and processes to identify and correct issues in your trial starting at Day 1. We embrace the Regulatory recommendations for rapid review and correction of issues—it protects research subjects and the integrity of the data and trial outcomes.
We evaluate, adopt, and use the latest technological solutions to perform more work remotely, faster, with fewer people, and in shorter timelines.
MANA RBM's Consultants respond to your requests and questions immediately—if only to let you know we are “on it”. We strive for 100% repeat business and delighted customers using methods as follows:
Proactive problem identification that starts at our Risk Assessment step in evaluating each protocol for high risk areas.
We develop plans for collecting the relevant data to evaluate these high risk areas.
We develop Data and Document Review Guidelines that integrate the activities of all study staff members across functional areas.
We build reports and data visualizations to enhance study data review in both completeness, timeliness, and efficiency.
Data collection and evaluation approaches that focus on identifying and correcting issues early in trial conduct.
Processes focused on remote trial management of data and documents, ensuring that the dollars allocated to monitoring trial quality are used for monitoring and not wasted on activities such as sitting in airports.
Our entire process is designed to minimize the use of fossil fuels and paper.
MANA RBM Consultants perform the majority of their work remotely using electronic data and documents to manage both the site and Sponsor documents. This means Sponsors save significant costs in paper, shipping, and storage costs while more efficiently using its resources.
Better use of space—When Sites maintain all documents electronically and monitoring visits are conducted remotely, Sites estimate they recover 25-30% of its space which then can be used for revenue generating activities. This makes sites more productive and profitable, factors important in completing studies more efficiently.
In accordance with the FDA guidance on Risk Based Monitoring, we use remote trial oversight and technology to do the bulk of our data monitoring as well as PI and Study Coordinator Monitoring Visits. We routinely visit sites at Study Initiation, Close Out, and “For Cause”. For a one year, 75 site study, instead of 650 on-site visits, we conduct approximately 225 onsite visits, saving approximately $425,000 in travel expenses including flights, driving, and hotels. There are additional savings on monitoring, but much of time that monitors were spending in airports is now dedicated to oversight of trial data and documents. An added advantage of monitors not spending time traveling is that monitors are more available to support sites and to focus on critical quality oversight.