One of the most important and often under-resourced aspects of clinical trials is vendor selection, management and oversight. If vendor management isn’t a top priority, it should be, as the FDA places large significance on this area, as is evidenced by the most recent updates to the Bioresearch Monitoring (BIMO) Program.
The Bioresearch Monitoring (BIMO) Program was initiated by the FDA to monitor every aspect of FDA– regulated research through on-site inspection and data audits, specifically focusing on ensuring the quality and integrity of the data submitted to the FDA. The Compliance Program Guidance Manual (CPGM) for sponsors, an aspect of BIMO used as guidance for FDA inspections, was recently updated to include more stringent guidelines for vendor selection, management and oversight.
This update, released in September of 2021, included updates/additions in the following areas:
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Selection and Monitoring of Clinical Investigators
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Outsourced services
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Selection of Monitors
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Monitoring Procedures and Activities
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Data and Safety Monitoring Board/Data Monitoring Committee
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Progress Reporting
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Safety Oversight
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Data Collection and Handling
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Electronic Records and Electronic Signatures
These updates focus heavily on aspects of vendor management with added emphasis on technological innovation, specifically data capture and monitoring. This comes as no surprise as clinical trials are becoming more heavily dependent on technology and largely outsourced to vendors, which drives the need for more regulation in those areas.
If vendor management is a weakness within your study, now is the time to start prioritizing improvements. MVG is uniquely positioned to be the expert partner you need to assure the utmost quality and compliance when it comes to all aspects vendor management from selection to oversight, to running routine audits. Our clinical quality expertise and hands-on approach provides our clients with the assurance that the integrity of their clinical trials will be maintained, even when using a wide network of vendors.
If you are in need of clinical quality support, especially when it comes to vendor management and oversight, contact our team at MVG to discuss how we can help bring your projects into compliance with the updated regulations.
MVG Consulting Services specializes in helping small to medium sized biotechnology and pharmaceutical companies with their clinical development programs and we can provide start-up and virtual companies with the necessary resources to begin their clinical development program.
Services include:
- Clinical Research Consulting Services
- Clinical Trial Development
- Project Rescue
- Inspection Readiness
MVG provides highly qualified clinical research professionals who seamlessly become a part of your project team. Additionally, we provide virtual companies with an entire project team that encompasses all aspects of clinical development.
We invite you to fill out the form below to learn more about how MVG Consulting can help you with your clinical devleopment needs.
