Pearl Pathways is a proud sponsor of the 2014-2015 Indiana Life Sciences Collaboration Conference Series, presented by the Kelley School’s Center for the Business of Life Sciences. This series provides the opportunity for various industry professionals to discuss...
After sixteen years FDA has released a new draft guidance with updated regulations concerning the obtainment of informed consent from clinical trial subjects. The guidance begins by reiterating the basic process for obtaining consent, beyond written documentation. FDA...
FDA has issued final guidance concerning the transfer of clinical studies between IRBs. According to Zachary Brennan on www.outsourcing-pharma.com, FDA says the transfer process “should be accomplished in a way that assures continuous IRB oversight with no lapse in...
We are pleased to announce that Pearl Pathway’s own Gretchen Bowker will be presenting a webinar on preparing for an FDA audit in December for the Society of Clinical Research Sites. Clinical research sites for biopharma and medical device companies are seeing a...
Alexander Gaffney from raps.org has just released an article on regulators releasing the latest guideline on electronically transmitting individual case safety reports (ICSR) from the International Conference on Harmonisation’s (ICH). ICH is a pharmaceutical...
