Advancements in AI-driven technologies, especially generative AI, are reshaping industries at a rapid pace. While prompt engineering—crafting inputs to guide AI—has been a focal point, context engineering is emerging as a critical approach for creating AI systems that truly understand complex domains. This distinction is especially important in AI-enabled medical writing, where precision, compliance, and clarity are paramount.  In this blog, we’ll explore the key differences

In 2025, several major pharmaceutical companies — including MSD (Merck), AstraZeneca, and Eli Lilly — have scaled back or cancelled planned investments in the UK. Decisions have ranged from pausing vaccine-manufacturing expansions to abandoning research center projects. 

Albert Einstein once said: “If you can’t explain it simply, you don’t understand it well enough.” Einstein’s words echo a principle at...

In clinical documentation, every word counts. One subtle yet powerful cognitive phenomenon that can shape how readers interpret and...

When I read McKinsey’s article, Rewiring Pharma’s Regulatory Submissions with AI and Zero-Based Design , I  couldn’t help but feel a mix...

The biotech industry is buzzing with excitement following the FDA’s announcement of its Commissioner's National Priority Voucher (CNPV)...

AI-enabled medical writing significantly streamlines the clinical documentation process, but common pitfalls can reduce its...

Recent research from Microsoft  offers one of the most comprehensive looks yet at how generative AI is already reshaping work activities...

Once Upon a Prompt  In academic and clinical research, time is a precious commodity—and so is clarity. With artificial intelligence...

As artificial intelligence becomes an increasingly powerful tool in regulatory and clinical writing, many professionals are eager to...

Using Speculative Fiction Techniques to Enhance Regulatory Submissions   Speculative fiction is a broad genre of literature that explores...

In the realm of communication, whether it is a casual conversation, a persuasive speech, or a clinical study report, our words carry more...

When you align your writing with both your strengths and the world’s needs, you create more than just content - you create impact.  In...

Discover how AI and structured content management are transforming regulatory submissions—boosting speed, consistency, and compliance in health authority interactions.

The FDA’s recent Evaluation of Labeling Submissions with AI (ELSA) pilot program has generated both curiosity and skepticism in the regulatory community. Early responses from reviewers using ELSA have been mixed, with some finding it helpful for catching inconsistencies or typos, while others found it redundant or disconnected from their workflows. While the effort is laudable, the ELSA pilot highlights deeper limitations in how general-purpose AI tools perform in complex, re

Integrating technology-assisted content reuse into medical writing can reduce stress for writers by preventing unnecessary rework and maintaining consistent document quality and compliance. This ensures timely delivery of important new therapies to the patients who need them. 

Safety narratives serve as a critical component of clinical trial documentation, providing a comprehensive account of a patient’s...

Instead of focusing on shrinking teams, medical writing leaders should use AI to expand their department’s scope and strategic value.

When implemented thoughtfully, AI can enhance job satisfaction, improve digital employee experience (DEx), and foster a great workplace culture.

Cancer unfolds when mitosis, or the process of cell reproduction, decides to break all the rules and go rogue. Despite significant strides in scientific understanding and cancer treatment, including use of artificial intelligence (AI) to accelerate cancer immunotherapy research, recent updates from the American Cancer Society cast a shadow on our optimistic journey.