Challenge
A public biopharma client ($5B market cap) faced one of its toughest clinical writing projects: a six-part “Frankenstein” CSR, essentially four studies combined into one with multiple protocol amendments. Traditionally, producing a first draft took ~40 working days spread across five months, creating major bottlenecks.
"If they can write this CSR, they can write any kind of CSR."
Head of Medical Writing at Public Biopharma
Source Documents & Inputs
Study Protocol
Statistical Analysis Plan (SAP)
Tables, Figures & Listings (TFLs)
Topline Reports
Safety Review Meeting Notes
CSR Template
Style Guide
Solution
The client piloted Peer AI to test whether it could manage a CSR of this complexity.
Shell creation tailored to client’s format
Data mapping into the CSR template
First draft generation using Peer’s AI engine
Collaborative review with client’s writers providing feedback
Peer AI Outputs
Results & Impact
57% more efficient: reduced writing time from 40 to 17 working days.
80% faster: shortened total time to first draft from 5 months to 1 month.
Higher draft quality: outperformed CRO manual writers on clarity and completeness.
Proven reliability: successfully handled client’s most complex CSR, building confidence to scale further.
"Going from 40 days down to 17 days is a pretty compelling efficiency gain. What we got back was quite impressive. It was a better draft than the things I’ve seen come out of a CRO before.”
Head of Medical Writing at Public Biopharma
