The ICH E6 Good Clinical Practice (GCP) Guideline, the current global standard for clinical trials, is estimated to have its public draft version of the third revision (known as “R3”) published this month, January of 2022.
The primary change that can be expected in the newest revision is the focus on quality by design (QbD) with specific new principles including:
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The input of quality into the scientific and operational design and conduct of clinical trials.
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Making clinical trial processes, measures, and approaches proportionate to the risks to participants and to the reliability of trial results.
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Describing clinical trials in a clear, concise, and operationally feasible protocol.
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Ensuring clinical trials are generating reliable results.
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The clear documentation of roles, tasks and responsibilities in clinical trials
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The manufacturing of investigational products used in a clinical trial in accordance with applicable Good Manufacturing Practice (GMP) standards and be storage, shipping, and handling in accordance with the product specifications and the trial protocol.
As the release date of this update approaches, companies must prepare for the changes that this revision will incur. As regulations are updated, so must the compliance infrastructure within companies. Quality assurance will be all the more important as the industry moves towards more technologically-driven clinical trials, allowing for trials to be more individually structured around their purpose and associated risk.
The time for companies to act and begin adapting is now, and MVG is uniquely positioned to be the expert partner you need to assure the utmost quality and compliance within your company. 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 amongst changing regulations.
Please click here to contact MVG to discuss any Clinical Quality Assurance needs at your organization.
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.
