OrthoTrophix' Intra-Patient Randomization Design Supported by Advanced Cold-Chain Packaging

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 moderate

EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market

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 what

For the Clinical Supply Field – Some Brexit Answers, More Questions

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, and

How to Navigate Clinical Supply for Breakthrough-Designated Drugs

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 study

PART 3 OF 3: The QP Process Quiz for Clinical Supply Professionals

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:

PART 2 OF 3: The QP Role and Annex 16, Stability Data, and Audit Reports

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.

PART 1 of 3: Top Clinical Supply QP Questions Asked at the 2017 Sherpa Summer Seminar

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 to

Top Brexit Questions Asked by Clinical Supply Professionals at the 2017 Sherpa Summer Seminar

The results are in - based on our survey of San Diego's clinical supply community, there are a lot of concerns around Brexit's impact on clinical supply, as we  laid out in our previous overview of Brexit blog post. We've taken the top questions

Sherpa Summer Seminar Photos and Review

The 2017 Sherpa Summer Seminar brought San Diego's clinical supply community together for an afternoon of thoughtful discussion, and networking. Our expert panels answered the audience's specific questions on the QP process and the impact of

A Note to the Drug Development Community, From a Patient’s Perspective

The daily grind of getting a drug to clinical trial is grueling. When one is lost in the midst of seemingly never-ending paperwork, obstacles, and deadlines, the stress can pile on. Getting a drug to market is a marathon, not a sprint - but