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.
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.
Interest in digital approaches to clinical protocols has grown steadily as sponsors, solution providers, sites, and regulators explore ways to make study planning and execution more efficient. Read the full article featuring Rob DiCicco from Clinical Leader here.
Regulatory divergence across major markets is creating strategic complexity that compounds geographic competitive pressures. Read the full article featuring Allison Cuff Shimooka from Citeline here.