Medical Writing
Faster regulatory drafting, no compromise
A top-10 global biopharma company needed regulatory and medical documents drafted faster, with no loss of quality or compliance. We combined a trusted-source knowledge base and AI drafting copilots with medical writers who review and sign off every output.
At a glance
- Client: A top-10 global biopharma company
- Documents: Regulatory and medical documents, such as clinical study report sections
- Team: Gen AI drafting tools from Alethic Insights, with HealthMinds medical writers
- Result: >60% less drafting effort; ~30% faster time to submission
- Area: Enterprise Engagement, Medical Writing
The challenge
The client's writing teams had a long queue of regulatory and medical documents, each with a fixed submission date. Writers spent most of their time on the first draft: finding the right source, copying approved text and checking it again.
Hiring more writers was slow, and the client would not accept any drop in scientific quality or compliance. General AI tools were not an option either. Text without a clear source cannot go into a regulatory document.
Our approach
We paired a controlled AI drafting set-up with expert medical writers. The tool drafts; people check and sign off.
- Trusted-source knowledge base: Only the client's approved sources (protocols, earlier reports, standard text and guidelines) were loaded into a secure knowledge base. The tool drafts from these sources and nothing else.
- Drafting copilot in the writer's document: A writer asks for a section, for example the purpose of the study. The copilot searches the sources, shows where each statement comes from and drafts the text in place.
- Writer review and sign-off: A medical writer checks every statement against its source, edits it and signs it off. No output moves forward without that sign-off.
- Tracked versions: Every draft and every change is recorded, so reviewers can see what changed and why.
What we delivered
- Secure knowledge base built on the client's approved sources
- AI drafting copilot set up for the client's document templates
- Source shown for every drafted statement
- Medical writer review and sign-off on every output
- Version history for each document
The result
>60% less drafting effort
~30% faster time to submission, with consistent quality.
Drafting that used to take months of manual work now starts from an expert-approved first draft produced in hours.