Features

Industry Approaching Inflection Point in Consolidation Towards Large Health Systems

April 9, 2018

The clinical research business is approaching an inflection point similar to the shifts seen over the past 25 to 30 years, only now the trends are toward consolidation in larger health systems and their affiliates that can take a more patient-centric approach, according to Ken Getz, director of sponsored research programs at the Tufts University Center for the Study of Drug Development.

Electronic Storage of Work Correspondence – GCP Questions, FDA Answers

March 19, 2018

FDA regulations provide guidance for the handling and storage of electronic records, including email. The regulations do not, however, provide answers for every possible question. FDA’s Office of Good Clinical Practice responds to questions from the public interpreting FDA’s position, offering advice on how to proceed and pointing out key documents and resources that provide more guidance. The following question and OGCP answer regarding the electronic storage of correspondence comes from their website.