Found 119 results in Expert Content

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.

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.