by Kimberly | Mar 23, 2022 | Subscriber Articles
ICH E6 (R3) Guidelines for Good Clinical Practices (GCP) have been a work in progress to put forward changes to the previous R2 version. The overall purpose is to revise principles that account for ethical trial conduct, participant safety, and clinical trial...
by Kimberly | Aug 4, 2021 | Subscriber Articles
An FDA inspection can be triggered by a variety of factors with submission of an application for product approval as one of the most popular factors. With the increasing need to outsource to clinical research vendors, inspections of sponsor companies tend to focus...
by Kimberly | Jul 21, 2021 | Subscriber Articles
There has never been a better time to be in clinical research. From constant scientific innovation to being a part of a community of academic experts, there are seemingly endless opportunities to grow. While it all might seem exciting from the outside, organizations...
by Our Team | Jul 6, 2021 | Blog Articles, Subscriber Articles
By Afifa F. – 2K Clinical Consulting, Inc. There is a popular saying in quality management that if you do not have the process written down, then it probably didn’t happen. Just like any other business, Clinical trials must have a management system as...
