In late August 2011, the FDA has issued a Draft Guidance (http://1.usa.gov/rjmVrh) to assist sponsors and clinical investigations in developing risk-based monitoring strategies. Shortly after, the EMA joined the FDA in advocating a risk-based approach for monitoring of clinical trials. I will not go into the details of the draft document but in brief, these

“The definition of insanity is doing the same thing over and over again and expecting different results” – Albert Einstein There are 60+ EDC solutions vendors on the market and maybe more. Some are big, some are small but they are all doing the same thing… the same way. So why are there so many