Clinical Studies

Clinical Study Monitoring - Lachman Consultants

Q&A Document On Clinical Study Monitoring Offers Additional Information

The monitoring of clinical studies is extremely important to protect the rights, welfare and safety of the study participants, and to assure the integrity of the study data submitted to the FDA and thus, ultimately the accuracy of FDA’s evaluation of submitted studies and subsequent approval decisions.  If you have been following the debarment notifications […]

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What Did We Learn from Conducting Clinical Trials During the Pandemic?

The MHRA Good Clinical Practice Symposium was a virtual event this year due to COVID‑19.  More than 800 individuals from over forty countries across the globe attended.  Throughout the three‑day event, speakers provided their perspectives on clinical trials from their roles as inspectors, assessors, and reviewers representing the MHRA, FDA, and Health Canada.  The agenda provided […]

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Ensuring Manufacturing Continuity for Essential Medicines

John Darby, M.Sc., Senior Director of Lachman Consultants, wrote a recent article for Contract Pharma applying the principles of Quality Risk Management to get medicines to market faster. Here is a brief excerpt from the article: “As vaccine development progresses globally to address the coronavirus pandemic, assurance of manufacturing capability to address supply needs is […]

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What Were These People Thinking?

A Department of Justice press release (here) announced a 19 count indictment against 9 individuals “with conspiracy to commit mail and wire fraud, mail fraud, wire fraud, aggravated identity theft, conspiracy to defraud the United States, and failure to maintain adequate records.”  Basically, the press release goes on to describe fraudulent activities relative to the […]

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