Kestrel Therapeutics is a clinical-stage biotechnology company developing medicines for patients with intractable cancers driven by KRAS mutations. With a candidate advancing into a Phase 1 study in patients, Kestrel needed a full set of informed consent forms (ICFs) ready on a tight timeline. The team partnered with Peer AI to compress what is traditionally a months-long, multi-vendor authoring process into a single two-week sprint, without compromising on the standards that ICFs require.
Challenge
A trial timeline with real patient impact. Patients couldn't be enrolled until ICFs were finalized. Every week of authoring delay was another week patients were left waiting.
Six documents, one consistent voice. The project required one master ICF plus five variations, each 10 to 15 pages and each subject to the same ethics (IRB) and regulatory scrutiny. Authoring each document separately would have introduced inconsistencies and consumed dedicated cycles to reconcile.
A high bar that couldn't move. ICFs need to meet AMA 11th edition style, satisfy ICH GCP content requirements, and land at a 7th-to-8th-grade reading level, while accurately reflecting the protocol and the risks to participants. Any solution had to clear that bar on the first pass.
A traditional process built for a different pace. Kestrel's prior approach relied on external vendors at roughly 2 weeks per document. For 6 ICFs, that meant either months of sequential authoring or paying for multiple teams running in parallel.
The Approach
Kestrel chose Peer AI because the Peer AI platform uses agents to take a regulatory convention and generate a brand-new, Kestrel-specific ICF from the ground up. Compliance wasn't a post-hoc formatting pass. It shaped the document generation itself.
The engagement ran in three stages:
Source ingestion and setup. Peer AI's agents ingested Kestrel’s source documents (including ICF template, sponsor style guide, protocol) and generated the documents against the ICH GCP content requirements that ICFs are required to follow.
Master ICF generated from scratch. Peer AI's document agents generated a Kestrel-specific master ICF directly from the source material, written to AMA 11th edition style and completed in approximately 4 hours on the platform. Kestrel reviewed and signed off on the master.
Five ICF variations from the approved master. With the master locked, each of the five ICF variations was generated on the platform in approximately 4 hours, with consistency across the set, and a 7th-to-8th-grade reading level held across every document, guaranteed by the shared master rather than re-litigated across parallel writing teams.
Results
The full set of 6 ICFs was delivered in 24 hours of work over a two week period.
Efficiency
~95% time savings per document. Each ICF, which previously took roughly 2 weeks of vendor time, was completed in approximately 4 hours on the Peer AI platform.
Project completed in 2 weeks. A scope that historically would have required multiple months of sequential authoring, or multiple vendor teams running in parallel, was delivered as a single coordinated workstream.
Quality
Peer AI evaluates every output against a defined quality framework spanning accuracy, completeness, readability, consistency, and source traceability. On the Kestrel ICFs, that framework translated into outputs Kestrel's team could review the same way they would review human-written documents, with no need for a separate "AI quality" pass. The team reported that the documents were comparable to human authoring on every dimension that mattered.
Customer Quote
"What impressed me was that these weren't generic templates dressed up for Kestrel. The master ICF was built from our source material, in our voice, to the standards we hold. We were extremely pleased with what came back, and with how quickly. That pace helped us move into enrollment on time"
Tammy Pasqualini
Senior Director Clinical Development Operations, Kestrel Therapeutics
Looking Ahead: From molecule to medicine
With the ICF package delivered on time, Kestrel was positioned to keep its clinical timeline on track. Peer AI's mission is to accelerate the regulatory path from molecule to medicine, so life-saving therapies reach the patients who need them sooner. Engagements like Kestrel's are what that mission looks like in practice: removing weeks of authoring delay so patients don't have to wait.
