Blog
Updated GCP guideline for clinical trials
As covered in an article by Zachary Brennan in raps.org, the ICH has updated their GCP guideline with the goal to simplify and cut the cost of clinical trials. The aim is to create a more “unified standard for the regulatory authorities in the EU, Japan, US, Canada...
Obama nominates Robert Califf as FDA commissioner
With the previous resignation of Commissioner Margaret Hamburg, there has been talk that current deputy commissioner for medical products and tobacco, Robert Califf, may soon be the new US FDA commissioner. Concurrently, the US Senate is working to permanently...
Site Solutions Summit 2015
The SCRS is hosting the 10th annual Site Solutions Summit in Amelia Island, Florida from October 8-11. Diana Caldwell, Pearl Pathways' CEO and President, will act as a panelist on October 10th at 4:00pm for "The Truth of its Impact for Your Site." To register for the...
Comprehensive partnerships help medical device research move forward
FDA recommends that partnerships should be used to better monitor medical device performance once released. The article states knee replacements as an example of an area that uses multiple different medical devices, yet the performance information has not been...
New GCP guidelines announced
After nearly twenty years with the current Good Clinical Practice (GCP) guidelines, ICH is publishing an addendum that will change definitions, principles and responsibilities for the future. These changes include new requirements of compliance and risk, many of which...