Protocol to CRF specification, from three weeks to a few hours.
Clinical Trial Protocol Automation
Before
2 to 3 weeks
Now
A few hours
The challenge
A global pharma company set out to roughly double its annual trial volume without growing the team in proportion. Every trial began with a person reading an unstructured protocol and hand building CRF specifications, which bottlenecked study build.
What we built
A modular platform that ingests protocols in PDF or Word and extracts structured study specifications, then generates CRF specs with CDASH mapping, schedules of activities, edit checks and specification files ready to ingest into the client's electronic data capture platforms. A human stays in the loop with editable fields throughout.
How it runs
- IngestProtocol parsed for metadata, design logic and criteria
- GenerateCRF specs, visit schedules and edit checks drafted
- ExportSpecification files ready for the client's EDC platforms
The result
- Hours
- Protocol interpretation, from 3 weeks
- 5
- Automation modules
- 2x
- Trial capacity target
Built with
- Document AI
- CDISC and CDASH
- Human in the loop
Run this in Pharma & Life Sciences
The same Document AI build, scoped to your sources and your reporting lines.