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In “Some Quality Food for Thought,” Beaufort’s John Wilson questions why quality improvements in clinical research are so slow to come about. Wilson suggests that the industry commit to systematic, practical and measurable applications of basic principles and he cites four areas that often … Continue reading
In this Spring 2012 International Clinical Trials article, Beaufort’s John Wilson argues that clinical trial sponsors can reduce the total cost of quality by implementing a third-party quality oversight program. Read the entire issue here.
In this article from the May 2012 issue of the Journal of Clinical Research Best Practices, Beaufort’s John Wilson argues that clinical research can benefit from QBD. Pharmaceutical manufacturing established a risk-based approach to quality more than a decade ago, … Continue reading
In the pharmaceutical industry, quality by design (QbD) has long been applied to manufacturing. Incorporating good manufacturing practices (GMP) into the production process is expected and required by the Food and Drug Administration (FDA). Yet, rarely are QbD practices adopted … Continue reading
Today’s clinical trials require quality oversight for one simple reason: sponsors are ultimately responsible for the integrity of the data generated by their third-party vendors. This is most evident in recent FDA warning letters issued to top-quality pharmaceutical firms for … Continue reading
“Third-party quality oversight: designing an optimal programme” was published in the August 2011 issue of Scrip Regulatory Affairs (see www.scripregulatoryaffairs.com).
Quality oversight of clinical trials gains traction as sponsors are held accountable by the FDA NORFOLK, Va., July 20, 2011—Clinical research organization (CRO) Beaufort, LLC, has added quality oversight to its services for clients in the pharmaceutical, diagnostics, and medical … Continue reading