Best of July 2025: Top 5 Insights In Clinical Supply Chain & Logistics

#1 - EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?

On July 1, 2025, the EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials is slated to come into effect. Learn more about the guideline and it's impact.

#2 - Writing Effective Clinical Regulatory Documents For Gene Therapy Trials

Clinical medical writing for gene therapy regulatory documents diverges significantly from medical writing for more traditional therapies. These best practices will help ease the document preparation process and result in a high-quality submission. 

#3 - 4 Centralized Comparator Sourcing Models To Fortify Supply Chains

Comparator supply decisions are becoming increasingly critical to the success of clinical trials, yet they are often made too late. Explore how a team at Novartis developed four models for centralized sourcing of comparators to support their internal pipeline.

#4 - Impact Of Data Concerns In Neurological Clinical Trials: Why Quality Matters

This is Part 1 of a 3-part series demonstrating how robust data analytics can address the real-world implications of data quality issues that affect patients waiting for effective treatments.

#5 - The New Clinical Packaging Paradigm: Differentiation And Decentralization

The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?