While much of the world remains on pause, drug development processes struggle to remain active and compliant, urging the need for alternate methods to keep things moving forward.
Now more than ever, it is important to leverage the tools already equipped to function in a remote society. While there is still much ground to be covered across the drug development process as a whole, certain regulatory aspects, such as the maintenance of trial master files, SOP refreshing, and remote auditing can be executed with relative ease. Below, is a snapshot of the regulatory aspects that you and your company can stay on top of with the help of MVG Consulting.
Trial Master Files (TMFs): The preparation of a TMF is essential prior to an FDA inspection. Prior to the outbreak of COVID-19 the use of eTMFs had already taken precedent over paper TMFs, and so the continuation of maintenance is well positioned to continue per usual. When given the proper access, a sponsor can review an eTMF in real time when they need to access various documents. A TMF should be contemporaneous and as up to date as possible, which is often not the case, as CROs struggle with upkeep and regular documentation uploads. It is important now, more than ever, to ensure that the right steps are taken to ensure your TMFs are up to date, and inspection ready.
Remote Auditing: No matter the current challenges that COVID-19 presents, the need for audits to ensure regulatory compliance remains paramount to the execution of clinical trials. Remote auditing eliminates the need for any face to face interaction through the use of electronic files, secure web portals, and videoconferencing, and can continue per usual with the help of a trusted parter.
An SOP refresh: ICH defines SOPs as “detailed written instructions to achieve uniformity of the performance of a specific function.” Most clinical research professionals find the task of writing SOPs to be insufferable, yet still necessary. Typically, other more pressing day to day tasks of getting a program up and running take precedent over writing SOPs, but now, with many of those formerly urgent tasks being delayed due to the effects of COVID-19, there is a perfect opportunity to take the extra time to complete tasks such as writing the SOPs.
Whether it be the maintenance of an eTMF, SOP refresh, or execution of a remote audit, MVG is well positioned to step in as a trusted partner to ensure that even in this uncertain time, progress can be made with your regulatory needs.
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.
