Earlier this week, I posted a quote about preparation and failure. While it might seem like a trite adage courtesy of Benjamin Franklin, I believe preparation is a good idea for everything from rock climbing to filing taxes. And of course, careful planning is critical to a successful clinical trial. In two previous blogs [31-Jan-18, Risk Averse? and 8-Feb-2018, The Only Thing You Have to Fear Is…], I discussed risk assessment and risk management, including the concept of risk

A colleague and I were recently sharing QA ‘war stories.’ She was relating to me her encounter with a, ‘But why?’ person in the GCP operations world. These are the folks who demand you point to ‘the specific regulation that says we have to have SOPs.’ After many years working in clinical research and development, there is nothing I would like more than GCP regulations that provide as many clear-cut requirements as GLP and GMP regulations seem to do. But alas, wishing has not