The new ICH Good Clinical Practice requirements, effective July 2017, require a comprehensive quality approach including rapid, remote review of data and documents.
MANA RBM has developed, and refined over nearly a decade, products to support comprehensive, remote trial management.
MANA RBM offers innovative products to provide users with unsurpassed flexibility to capture the most important data to manage and oversee trial conduct, protocol compliance, IP management, and subject safety.
REACHERTM (patent pending) is the first and only automated analytic tool that:
- Automatically, in near real time, identifies the Errors that Matter that occur within and across all the databases, including audit trails, that are used in a clinical trial.
- Notifies you immediately when an urgent error such as a stopping rule or SUSAR is identified.
- Directs workflow for the entire study team, including research subjects without ever having to log into the system.
- Provides a comprehensive tool for trend and systematic error analysis
- Delivers a comprehensive quality management tool to perform and document all quality management activities for a trial.
REACHERTM is already integrated with the STARTM database described below.
Site Tracker Analyzing Risk (STAR)- STAR Database
MANA RBM’s proprietary STAR database provides Sponsors and CROs with a flexible tool customized to conduct your specific trial.
The STAR database captures critical, new data required for a total quality management approach including Risk Assessment, Issue Management, and CAPA oversight.
STAR enables electronic collection of documents traditionally maintained in paper at the research site (e.g., Delegation of Authority, Training Records), in Clinical Trial Management Systems (eMonitoring Reports and Monitoring Scheduling), and in trackers (Feasibility Questionnaires, Debarment Checks) for site selection and Medical Review.
Critical forms such as Deviations are also included with added levels of categorization to enable more efficient trending as part of central review.
Forms can be customized to protocol specifics (e.g., feasibility, training and delegation of authority). Access is also managed to enable granular access privileges to forms.
The STAR database provides a robust tool for managing an individual trial AND it provides a valuable resource for planning and implementing future trials including data on Investigator Feasibility Responses and actual study conduct performance data.
The following figure shows all aspects of the STAR database incorporated into MANA RBM Custom Reports for Remote Trial Oversight (MANA Method). All aspects of clinical trial management, except the clinical data and third party vendor data, are incorporated into the STAR database.
MANA RBM deploys the STAR database through Medrio. STAR is a powerful tool for all aspects of study conduct, including study Start Up.
MANA RBM synthesizes data to focus on the critical data. This allows the study team to identify and correct issues rapidly. The graphic below explains the types of study-specific and operational reports used for each trial.
Subject Profile Analyzing Risk (SPAR)
The current approaches to remote subject review using review of eCRF pages has many disadvantages and limitations. By looking at data by data set and by visit in the CRF alone, data and process errors affect subject safety are easily missed. Another limitation of current review approaches: all data are considered the same; equal time and effort is spent on every data point.
MANA RBM’s proprietary SPAR eliminates those problems and pioneers a new comprehensive approach to critical data review. It synthesizes data across multiple data sets and data sources, normalized to treatment day.
SPAR provides a unique data visualization of high-risk data elements and processes (e.g., those affecting subject safety, protocol compliance, and data integrity) identified during the Risk Assessment process. SPAR helps monitors, data managers, and medical monitors see the entire picture of a subject’s progress in the trial—allowing context across data sets within a visit and across visits.
Monitors, data managers, and medical monitors describe SPAR as invaluable in identifying trends not evident using traditional monitoring approaches.
MANA RBM deploys SPAR through J Review. For companies without access to J Review, we provide a hosted solution to import all relevant data, SPAR, and to deliver any other custom reports needed to manage High Risk Data Elements and Processes.
Electronic Trial Master Files (eTMF)/Electronic Investigator Site Files (eISF)
While the industry has focused primarily on data to implement Risk Based Monitoring (RBM) and total quality management, documents represent a critical component for compliance. While developing a complete remote trial management approach, MANA RBM created a rapidly deployable, cost-effective, flexible eTMF/eISF solution based on the DIA reference model. MANA RBM can manage this solution or train your internal staff to do it.
Our robust tool allows access control to be maintained for subject source. It also includes a process for converting any paper document into a certified electronic source document as defined in 21 CFR Part 11.
MANA RBM’s eTMF/eISF solution includes specifications, work instructions including instructions for generating certified electronic copies, and customizable archives to support separating subject source documents from the Sponsor’s eTMF.