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.

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.

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.

How demand-led supply and DTP distribution can shape a DCT.

How shortening the timeline from development to clinic can be achieved through parallel processing versus using a task/time compression approach.

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

Learn how early collaboration with an integrated solutions provider can help to mitigate supply challenges.