Summary: Case Management Services provides end-to-end supply chain management and orchestration for autologous and allogeneic cell, gene and gene-modified therapies. Designed specifically to address the unique challenges associated with the safe and timely delivery of advanced therapies to patients.

Watch experts discuss country-specific considerations for clinical trial execution in the APAC region.

Summary: The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Selecting the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors successfully navigate these challenges.

Experts discuss integrated solutions in the pharmaceutical industry and the benefits and challenges of this approach. Is this the key to more aggressive development milestones?

In this Executive Summary, Catalent reviews which therapeutic areas are ripe for highly decentralized trials and which areas will be least resistant to this kind of change.

The role that comparator sourcing specialists play throughout the end-to-end clinical supply process

Create a reliable supply chain for autologous cell therapies that maintains compliance and ensures product safety and integrity.

On January 31, 2022, European Union (EU) member states became legally required to enforce the Clinical Trials Regulation (CTR) No. 536/201, intended to replace the Clinical Trials Directive (2001/20/EC), which had often been criticized.

Learn the differences in areas of expertise, focus and responsibilities between the Clinical Supply Manager, the Project Manager, and the Financial Project Analyst.

How an FPA can provide cost savings to sponsors.