FDA Modernization Act 2.0: Accelerate Readiness with an Advanced LIMS Solution
In April 2025, clinical research reached a turning point, with advances reshaping both the science and the regulations that guide it. The FDA unveiled its Roadmap to Reducing Animal Testing in Preclinical Safety Studies, offering a phased strategy for integrating non-animal methods into drug development. Around the same time, the NIH announced the launch of […]
AI Enabled Content Generation for Clinical and Regulatory Documents
What is the current state of AI in clinical and regulatory content? In Part One of our three-part series, we assessed your organization’s AI readiness for automating regulatory and clinical trial document creation. In Part Two, we explored Structured Content Authoring, defining this essential building block to establish modular frameworks representing all the data associated with clinical […]