Sep 30
Released at the start of 2025, the ICH-E6(R3) guideline is an updated international standard for how clinical trials should be designed, conducted, recorded, and reported. At its core, the guideline ensures that people who participate in clinical trials are kept safe and that the data collected is reliable and meaningful. This guideline is not a set of rigid rules, but rather it introduces clear principles that allow researchers and sponsors to make thoughtful, risk-based decisions tailored to each study’s specific needs.
Read the full article by The Medicine Maker here.
TransCelerate BioPharma has released its 2025 annual report, titled The Power of Forward, outlining a year defined by continued digital adoption, regulatory collaboration, and expansion of pragmatic approaches to clinical development. Read the full article featuring Janice Chang from Applied Clinical Trials here.
More than a decade ago, a group of pharma R&D heads gathered for an annual meeting focused on addressing common industry challenges. They had a running joke: With an average tenure of just three years, if they wanted to see each other at more than one of these gatherings, they’d better figure out how to…
Enthusiastic predictions from industry leaders for ongoing progress in obesity, oncology, immunology, neuroscience and more were supported by optimism for the potential of AI and other technological advances to enable breakthroughs in processes as well as pipelines. Read the full article featuring Rob DiCicco from Citeline here.