Clinical Studies

11
Mar

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 […]

Read More
30
Sep

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 […]

Read More
10
Aug

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 […]

Read More