Over the last decade, the life sciences industry has gone from running clinical trials on paper or, in many cases, in Excel, to leveraging comprehensive web-based systems, such as electronic data capture (EDC) and clinical trial management systems (CTMS). But, in more recent years, the widespread use of mobile technology has enabled even more innovative methods.
Technology affects many different aspects of clinical trials, from helping to recruit and keep patients engaged to capturing clinical and patient data, all the way to managing clinical sites and investigators. With the high costs and long timelines involved with conducting clinical trials, sponsors and clinical research organizations (CROs) are always seeking ways to trim the fat, so to speak. Turns out, the FDA wants a piece of it.
The FDA has issued a Request For Comments regarding the use of technology and other innovative methods in the conduct of clinical trials. Comments are due December 28, 2015.
Click here to read the FDA’s notice.
