RESOURCES
Working notes on clinical trial transparency since 2012 — disclosure, anonymization, and AI-assisted writing, by the people who do the work.
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…
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…
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…
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…
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…
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…
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…
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…
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.…
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…
