Blogs

Designing protocols to maintain a trial's validity while enabling seriously ill and informed participants to receive both SOC and investigational products will help to improve patient participation in oncology clinical trials.

Bio-pharmaceutical companies are continually tasked with gathering more safety information and responding to requirements more quickly. Recent examples of significant changes in reporting requirements include 2010/84/EU and Regulation Number 1235/2010 on pharmacovigilance, and the 2012 European Medicines Agency (EMA) new guidelines on good pharmacovigilance practices.