FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an...
The Alliance for Clinical Research Excellence and Safety (ACRES), a growing global network created to improve the safety, quality, and efficiency of clinical research, has announced their initiative to construct an open information platform supporting clinical...
An interesting article by Zachary Brennan on outsourcing-pharma.com highlights the current status in the adoption of quality by design (QbD) methods for clinical research. According to the results of a survey presented at this year’s Avoca Quality Consortium Summit,...
Pamela Scherer Mcleod from darkdaily.com wrote a very interesting article on how next-gen gene sequencing is affecting clinical research. Gene testing of patients enrolled in advanced cancer clinical trials may be able to supplement or even replace traditional...
Check out this article (login registration is required) entitled “What could proposed changes to the Common Rule mean to sites, sponsors and IRBs” published in the Q2 2013 edition of the Society for Clinical Research Sites’ online journal, InSite. ...
Pharmalive.com’s Ed Silverman reports that in another attempt to stop the European Medicines Agency (EMA) from continuing with their new policy for trial data disclosure, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has openly...
