Case study · Pharma sponsor
A mid-size sponsor freed $280,000 a year from drafting
Protocol amendments and regulatory drafting were eating weeks the team did not have.
A protocol amendment never stays in one place. It ripples through a dozen documents, and every one needs a draft, a review, and a sign-off. Medical writers were starting from blank pages at the end of long days, and reviewer time was the bottleneck sitting behind all of it.
We moved the drafting and the first-pass review onto an Agentic OS. The agent produces the draft and pulls the references, and the writer edits and owns the final text.
The numbers, over the first year
- Faster amendment turnaround: $80,000 recovered
- Medical writer hours reclaimed: $150,000
- Reviewer time freed: $50,000
$280,000 in year one on a $25,000 build, close to $790,000 over three years.
Mid-size sponsor. $280,000 first-year saving. $25,000 build. About $790,000 over three years.
Built for regulated work
Everything ran under the controls a regulated team needs. A named person signs, the work leaves an audit trail, and we evaluated the workflow against 21 CFR Part 11 before building it. The full posture is on our trust and security page, and an AI Audit is where the same engagement would start.
15 min. 5-day written diagnosis. No deck.