Found 91 results in Expert Content

Summary: This webinar addresses key challenges in the development, manufacturing and supply chain logistics for autologous and allogeneic cell therapies.

In this Executive Summary, learn best practices and the necessary proactive steps that need to be taken to build a solid clinical supply plan.

Summary: This webinar focuses on understanding your knowns and unknowns, best practices for mitigating risk and addressing the specific drug supply challenges commonly associated with adaptive, decentralized, platform and other complex trial designs.

Summary: This webinar focuses on best practices in the pre-award phase to build a functional relationship with your clinical supply partner, solidify a compelling strategy and drive alignment for success.

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.