Compliance with the rules and regulations related to clinical research is like working your way through a maze, and the federal agencies tasked with clinical research oversight can sound like alphabet soup to the uninitiated. Clinical research regulatory oversight…
EMA Offers Draft Guideline on Trial Master Files
The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the…
Google Offshoot Starts A 10,000-Person Study To Plumb Human Biology
It’s a realistic blueprint for how tech could change medicine. But it’s also an emblem of how long that transformation will take. Verily, formerly known as Google Life Sciences, plans to begin a long-awaited 10,000-person study to explore the biology of healthy people in…
