FDA’s Transparency Roadmap: What It Means for Clinical Trial Disclosure
By James Greene Key Takeaways The US Food & Drug Administration (FDA) has put public release of Clinical Study Reports on its agenda. For US sponsors, clinical document…
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What AI Drug Discovery Can Teach Us About Responsible AI Across the Clinical Development Pipeline
Artificial intelligence (AI) continues to create new possibilities across life sciences, and few areas make that clearer than drug discovery. At the recent MichBio 2026 Michigan Drug Discovery…
Helping Medical Writers Embrace AI Through Effective Change Management
Artificial intelligence (AI) is rapidly changing the way clinical and regulatory content is developed across the pharmaceutical and biotechnology industry. The AI medical writing market alone is expected…
FDA Flags Thousands of Missing Clinical Trial Results. Is Your Team Prepared?
The FDA recently contacted more than 2,200 sponsors and researchers connected to over 3,000 clinical trials that may be missing required results reporting on ClinicalTrials.gov. In an FDA…
Experts Share Real-World Lessons to Applying AI in Medical Writing
In a recent joint session hosted by TrialAssure and MMS, medical writing professionals from the US and UK gathered to explore one of the most talked-about topics in…
How TrialAssure is Building Better DSURs with Purpose-Built Prompts, Smarter Sources, and a Proven Approach
Every submission tells a story, but Development Safety Update Reports (DSURs) require a special kind of narrative. They blend clinical development history, emerging safety data, and a forward-looking…
Is Now the Time for Pharma and Biotech to Act with AI or Should the Industry Wait for a Better Model?
The integration of artificial intelligence (AI) into pharmaceutical and biotechnology workflows has accelerated significantly in recent years. According to peer-reviewed research by the Tufts Center for the Study…
The First Step Toward Scalable Medical Writing AI
Teams in medical writing are being pulled in every direction. Internal experts see how much pressure that they are under to move faster, improve quality, and manage rising…
What Sponsors Gain by Embracing the Design for Transparency Concept
In many industries, Design for Quality (DfQ) has long been a guiding framework. It teaches us to build quality into the process rather than inspecting for it later.…
Why Internal GenAI Builds in Pharma Often Fall Short
The promise of building your own GenAI solution can be tempting. Full control. Custom features. Long-term savings. But in practice, most life sciences organizations find that internal builds…