Are you considering Direct-To-Patient Supply Strategies for your clinical trial?
If your answer is YES, remember to start conversations early.
Early conversations should include:Read More
Sean Baumstark is a captivating advocate and a real warrior who has been fighting Friedreich’s Ataxia, a rare, debilitating and life-shortening disease that attacks multiple systems in the body, since the age of 25. Sean will be sharing his storyRead More
Novel drug and trial design generate unique clinical supply management challenges. OrthoTrophix began a two-part, phase 2 clinical trial in February 2014. The first part tested the drug’s safety and efficacy in 27 patients with mild to moderateRead More
March 27, 2018
Change Your Perspective
EU Good Distribution Practice (GDP) require that sponsor companies have a thorough understanding of how clinical supplies are handled and temperature monitored.
For example, do your clinical sites know whatRead More
It is no secret that Brexit will have a large impact on the pharmaceutical industry come March 2019 when the UK exits the EU. Since the UK voted to leave the EU on June 23, 2016, questions have been raised on the logistics of the transition, andRead More
Clinical studies of breakthrough therapy-designated drugs present multiple clinical supply management issues, such as the need to adapt to rolling FDA recommendations regarding clinical study design, endpoints, and study size, even once the studyRead More
We've put together a fun little quiz for you to test your Qualified Person (QP) knowledge. If you haven't read our previous blog posts on the QP process, Top Clinical Supply QP Questions Asked At The 2017 Sherpa Summer Seminar and PART 2 OF 3:Read More
Following up on last week’s Top Clinical Supply QP Questions Asked At The 2017 Sherpa Summer Seminar blog post, below are additional scenarios that your clinical supply colleagues got answered by our expert QP panel at the Sherpa Summer Seminar.Read More
Any sponsor company planning clinical studies in Europe needs to be prepared for the QP process. Our first blog post outlining the QP processes proved to be one of our most popular blog posts to date. That and the tremendous response we got toRead More