I’ll be in DC to run the inaugural Trial Master Files Summit, January 19-20 at the Weston Arlington Gateway. Launch events are always exciting – this one should have about 75 people in the room. The focus of this conference is to uncover the best way for pharma companies to have clinical trials managers file their documentations so that they are prepared for FDA inspections. Click here if you want to see a full agenda. Click here to join me!
Voluntary associations taking initiative and collaborating
Several clinical trial leaders from big pharma and related consultants and vendors will speak about the work they have been doing to establish industry standards for preparing clinical trial documentation for FDA inspection. I’m curious to hear whether there is much discrepancy between what the scientists running the trials think is necessary to prove safety and efficacy from their scientific viewpoint versus what they must show the government inspectors.
Government regulation and scientific progress
My libertarian inclinations are always tempered by an understanding that people rely on government agencies like the FDA for safety, whether that is ideal or not. But it is still disenheartening that companies must dedicate so much human capital to organizing their clinical trial documents in a way that is designed to accommodate the FDA, which doesn’t even offer specific guidance as to what they will need.
Fortunately, I’ve secured Ann Meeker O’Connel from CDER to review what kinds of documentation will satisfy FDA inspectors.
Old businesses and new technologies
Other topics include pharmaceutical companies upgrading to electronic trial master files. It takes a long time to integrate technology into a large multi-national corporation, so it will be interesting to see how they approach this task – technology changes quickly, so corporate tech departments have to anticipate how their company will use the technology years down the road. But as outsourcing becomes standard and cloud computing comes of age, pharma companies are gradually going electronic with their filing. Only a small number of companies are completely electronic, so this is an important topic.