MANA RBM can design custom processes for adopting RBM including developing SOPs, training, and Change Management
MANA RBM provides support for organizations in designing and implementing customized RBM processes. MANA RBM will train your entire organization or project team in protocol and process-specific areas involving Risk-Based Monitoring and Remote Trial Monitoring. We lead and support your team through the risk assessment process (pre and post-protocol approval), design of technology systems, and protocol (or process) specific training on oversight and issue management.
When organizations successfully make widespread, process changes, a critical element involves incorporating and adopting a Change Management process. MANA RBM provides guidance and support to help organizations incorporate Change Management in its adoption process.
eClinical Technology Systems Selection and Set-up
- eClinical Trials technology has traditionally been the responsibility of different functional groups. Selecting or designing tools and implementing and delivering them on time for study start up has been a challenge for Clinical Research Teams.
- Each technology tool can significantly enhance access to data on study performance and subject safety. Teams must understand the key requirements each tool needs to achieve the goal of quality trial management.
- Once the correct tool has been selected, designing its implementation (i.e., what to collect, organize, and export) is an opportunity to optimize the trial process. This includes assuring inter-operability (e.g., transfer of key data from one system to the next without requiring transcription of data), common data standards, reporting across all systems, and on time delivery and testing of all systems.
- For instance, if the data collection tool is set up properly, monitors can remotely assess whether protocol and CGP compliance are being followed. This approach differs from the traditional collection of all GCP compliance data on paper that requires an onsite visit to review.
- When implementing a quality management approach to clinical trials, understanding how each of the technology tools can help to achieve an optimum benefit is critical. This includes understanding what data are considered “eSource” and who entered the data and when. Sponsors and CROs benefit from MANA RBM’s support in selecting and designing the software tools and defining who will review the data, the frequency of review, and the process for sharing findings.
- MANA RBM can help in selecting tools and designing processes that meet the overall strategy for clinical development using the principles of Quality by Design, Risk-Based Monitoring, and Remote Trial management.
1.) eClinical Data Collection: eSource/EDC Design for optimized remote monitoring
- MANA RBM helps organizations select and optimize its data collection tools. This includes setting up data collection to align with the FDA and EMA guidance listed below. MANA RBM focuses on all data needed to assure protocol compliance, GCP Compliance, and Investigational Product Management. Study oversight can be reviewed faster and remotely as opposed to traditional approaches.
- MANA RBM data collection approach includes the data needed for full quality oversight. This includes designing the configuration of the system for a specific trial and data collection requirement and testing of software. We focus on collecting all data needed to monitor the conduct of a trial including Issue management, electronic Monitoring Reports, electronic Delegation of Authority, training records and IP management; all data is maintained electronically. When data are carefully collected, reporting can enable more efficient quality oversight.
2.) eClinical Document Management: electronic Trial Master File/electronic Investigator Site Files
- MANA RBM has assisted the Pharmaceutical, Biotech, and Device industries in adopting eClinical Document Management Systems (e.g. electronic Trial Master Files (eTMF).
- MANA RBM also strongly recommends Sponsors adopt electronic Investigator Site Files (eISF). This tool significantly enhances remote site management and assures documents are reviewed quickly and that a full set of site documents are available at any time, from any location, to those with the required access privileges.
- Informed Consent errors are consistently one of the top findings from FDA Site Audits. Using an eISF can ensure informed consent errors are identified quickly and that the site has all subject informed consents available and complete.
- Special system requirements are needed for eISF systems to comply with regulatory requirements. MANA RBM helps companies select the right system for its requirements and price point. MANA RBM sets up the eISF system requirements, provides processes for using the eISF, archives the documents, and trains teams on its use.
- MANA RBM also provides additional tools to assure site documents are complete and correct throughout the trial and archived appropriately to maintain Personal Health Information. MANA RBM offers processes for converting any document to a certified electronic copy that can be reviewed and managed remotely, based on 21 CFR Part 11.
- MANA RBM can also provide an eTMF and eISF for Sponsors that want a solution for a single study without purchasing a system or going through the lengthy process for setup of a custom system. MANA RBM's eTMF and eISF are specifically set up to align with the DIA Reference model for electronic Trial Master Files.
3.) eClinical Reporting Tools and Data Visualizations
- MANA RBM helps Companies select a reporting system that works for them and then design the reports to support trial oversight.
- Adopting the FDA, EMA, and ICH guidance on Quality Trial Oversight requires access to robust reporting tools that incorporate data from many different electronic systems.
- In contrast to the data used for analysis, which is often converted to the CDISC (Clinical Data Interchange Standards Consortium) standard of SDTM (Standard Data Tabulation Model) that is required for regulatory submissions, the data needed for quality oversight is different as described below.
- To perform proper oversight, it is important to review data in context. This often requires data to be aggregated from different technology systems. MANA RBM uses eClinical Solutions data repository elluminate™️ to collect the data from the various electronic systems. MANA RBM's imports critical data such as audit trail data, queries, and deviations into its reporting suite (these data fields are not readily available when data is converted to SDTM format). Our reports are designed to “drill down” to better understand the data implications. We also use proprietary algorithms to enable rapid identification of outlier sites that require more oversight.
The Figure below shows how all the data are regularly imported into the repository and then used to provide reports that support Site Trial Conduct, Monitoring, and Central Oversight.
- MANA RBM created and offers innovative, proprietary eClinical Data Visualizations like the Subject Profile Analyzing Risk (SPAR). SPAR provides a solution for monitors that enhances the total oversight of each subject’s data while decreasing subject data monitoring time by more than 80%. It took monitors less than 30 minutes to learn how to use SPAR and users identified more issues faster than with traditional EDC review.
- SPAR synthesizes data across multiple different data collection systems including EDC/eSource, IVR, ePRO, labs, and other critical data items required for the trial. Contact us to learn how SPAR can work for you.
4.) Additional eClinical Tools:
- MANA RBM’s services also support the adoption or integration of eConsent into trials. This includes assuring the consent is correctly configured and GCP requirements are met. In addition, eConsent systems must be set up to manage changes in informed consent and the variability of approval across different Institutional Review Boards (IRB)/ International Ethics Committee (IEC).
- MANA RBM also offers services to assure data from the eConsent date of signature is imported into the data collection tool. This ensures the appropriate checks for start of study assessments occur the informed consent is signed.
- ePRO and eDiaries
- MANA RBM designs ePRO and eDiaries to collect the correct data and integrate it into reporting tools to ensure accurate completion of diaries and appropriate follow up. MANA RBM provides clients with many different solutions including Interactive Voice Response (IVR)/Interactive Web Response (IWR) systems, web diaries, text systems, and Bring Your Own Device (BYOD) systems.
- MANA RBM aligns the data collection system with the ePRO and eDiaries. We ensure the appropriate data is transferred into the EDC to eliminate transcription and satisfy the FDA’s guidance on ePROs and eSource.
Issue Management Systems
Implementing Risk-Based Monitoring and Total Quality Management for Clinical trials requires a method to identify issues across all team members in a trial. The tool must enable:
- Defining the scope,
- Capturing root cause analysis for major issues,
- Documenting Risk mitigation
- Confirming the outcome of the risk mitigation.
MANA RBM’s Issue Management Approach delivers on all of these components. This system can be implemented in a wide variety of data collection systems. It is already developed for the MedRio system and will soon be available for Medidata Rave.
Investigational Product (IP) Oversight
- A significant component of IP oversight can be accomplished remotely. MANA RBM works with Sponsors and CROs to synthesize data from a variety of sources to assure proper receipt, randomization, distribution, and return/destruction of IP.
- A key component of study oversight includes monitoring reports. Monitoring reports are designed to significantly decrease the amount of work required for notification of visits, documentation and approval of visits, and communication of findings with the PI. MANA RBM designed a suite of reports that are easily incorporated into any data collection tool. We focus on how best to analyze data from monitoring reports not just simply copying a paper monitoring report into your data collector (e.g., Electronic Data Collection/EDC).