Safety Blog: AI in Medical Writing: Disruption or Evolution?
As AI tools like ChatGPT become more embedded in medical writing workflows, one thing is clear: It’s not about AI versus Humans—it’s about how we intelligently integrate AI into high-stakes scientific communication.
In regulatory and publication writing, AI has the potential to accelerate timelines, enhance consistency, and reduce manual load, all while preserving the integrity of content rooted in scientific evidence.
Across the document lifecycle, here’s how AI is already adding value:
- Literature Planning & Evidence Mapping
AI supports rapid scanning of scientific databases, extraction of key data points, and synthesis of literature—streamlining early-stage research and gap analysis. - Drafting & Content Development
From initial scaffolding of CTD modules, CSRs (Clinical Study Reports), IBs (Investigator’s Brochures), to first drafts of plain language summaries or abstracts—AI can transform structured inputs into coherent, compliant outputs. - Language, Tone & Style Harmonization
AI enables real-time grammar refinement, terminology checks, and format alignment with AMA/ICMJE/ICH standards, reducing back-and-forth editorial cycles. - Reference Management
Automated citation generation, duplicate removal, and formatting tailored to journal or agency requirements improves operational efficiency. - QC & Compliance Checks
AI can flag deviations from regulatory templates (e.g., EMA/US FDA guidance), identify content inconsistencies, and support internal review cycles—saving hours in revisions. - Submission Readiness
From cover letters to author forms, AI tools can assist in preparing supporting documentation aligned with journal or regulatory platform needs.
But let’s not overlook what AI cannot replace:
- Clinical reasoning
AI can analyze patterns, but it lacks the ability to interpret nuanced clinical scenarios, co-morbidities, or physician decision-making rooted in real-world variability and patient-specific factors. - Regulatory interpretation
Guidelines from agencies like the FDA, EMA, or CDSCO are rarely black-and-white. Applying them requires contextual judgment, experience with evolving precedents, and an understanding of both the letter and spirit of the regulation. - Deep therapeutic understanding
AI cannot fully grasp disease heterogeneity, unmet needs, or the shifting competitive and clinical landscapes that shape how data are interpreted, positioned, and communicated across therapeutic areas. - Strategic messaging for diverse stakeholders
Crafting messages that resonate with clinicians, regulators, payers, and patients involves not just wordsmithing—but tailoring the why these matters to each audience. This requires empathy, insight, and scientific intuition that AI lacks.
At Fortrea, we believe AI is not a shortcut—it’s a force multiplier when combined with the clinical insight, writing expertise, and ethical judgment of trained medical writers.The future of medical writing is not AI versus human. It’s AI-powered human expertise.
Contact us to explore solutions to advance your medical writing needs