Challenge
An emerging biotech company wanted to evaluate whether an AI-powered approach could match or exceed traditional CRO quality while reducing timelines and costs for CSR authoring. As part of a Phase 1 trial, the team conducted a side-by-side comparison of Peer AI’s automated writing platform against their existing CRO process. Typically, outsourcing CSR drafting takes around three months (≈12 weeks) for a first draft. With tight timelines, the company needed to accelerate the writing process while maintaining their high bar for quality.
Source Documents & Inputs
Study Protocol
Statistical Analysis Plan (SAP)
Tables, Figures & Listings (TFLs)
Listings
Solution
The client partnered with Peer AI to author a Phase 1 CSR in a head-to-head comparison with their CRO’s output. The Peer AI platform ingested client’s source trial data (protocol, SAP, tables, listings, etc.) and auto-generated a full CSR draft, refined collaboratively with the team through regular review sessions.
Automated Draft Generation: Peer AI converted complex trial data into a complete, well-structured CSR aligned to the client’s template and style.
Collaborative Review: Client experts provided clinical insights and feedback in focused sessions, enabling fast, iterative refinement of the draft.
Quality Evaluation: Drafts were assessed against key quality dimensions (accuracy, completeness, and readability) to ensure outputs met internal standards.
Peer AI Outputs
Results & Impact
"Peer AI set a new benchmark for both speed and quality. The first draft was ready in only weeks, not months. The writing was structured, clear, and scientifically accurate. It’s rare to see that level of quality achieved so efficiently and it’s redefined our approach to document creation.”
Director of Clinical Operations, Emerging Biotech
Peer AI enabled a much faster drafting timeline without compromising quality:
83% faster to first draft: Peer AI delivered a CSR draft in 2 weeks (after initial ramp up time) vs 12 weeks for the CRO.
Improved completeness: Peer’s draft included all required sections (e.g. conclusions, antibody analysis) that were missing in the CRO’s version.
High clarity and quality: Internal reviewers described the Peer draft as “stronger writing” with “good flow,” while it matched the CRO on accuracy.
Maintained compliance: Both drafts adhered to ICH guidelines and required minimal rework for regulatory compliance.
Efficiency Gains:
Metric | Peer AI | CRO | Impact |
|---|---|---|---|
Timeline to first draft | 2 weeks (after initial ramp up) | 12 weeks | 83% faster delivery |
Peer AI Platform Performance and Quality:
Strengths | Details |
|---|---|
Writing Quality | Stronger writing with polished content and good flow |
Completeness | Included all required sections that CRO initially omitted |
Demographic Detail | Better demographic summary than CRO |
Overall Scores | Matched or exceeded CRO in most evaluation categories |
Source: Evaluations were completed by four independent client reviewers, including two Clinical Operations SMEs, one AI SME, and one Clinical Development SME.
