Newsletter | August 19, 2025

08.19.25 -- 7 New MHRA Guidances To Help You With Decentralized Manufacturing

SPONSOR

Join us on September 24, 2025, for a free virtual expo tailored to clinical teams evaluating IRT/RTSM platforms. Get live 15-minute demos, real-time Q&A, and side-by-side comparisons from top vendors. Ideal for Clinical Ops, Trial Supply, Data Management, and Procurement professionals, this event helps accelerate vendor selection and streamline study planning.

FEATURED EDITORIAL

7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies

The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

INDUSTRY INSIGHTS

Data-Driven Adaptive Trials Enhance Safety, Progress, And Economics

By offering guidance on optimizing ROI from extensive data collections and various endpoints in clinical studies, learn how IRT technology can enhance the data-driven approach for sponsors.

Speed To Market – API Large-Scale Commercial Manufacturing

Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change

A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.

SOLUTIONS

Commercial Drug Sourcing For Clinical Trials