Clinical trial study build
Protocol intelligence builds your study, not the reverse
Concordare reads your protocol document and creates an EDC database build. Your clinical team reviews, not transcribes.
Platform capabilities
Three capabilities, one workflow
Protocol Parsing
AI reads your protocol PDF and identifies visit schedules, endpoint definitions, eligibility criteria, CRF requirements, and amendment history.
Database Generation
Parsed protocol content maps to CDISC CDASH domain patterns and becomes a complete study database build with forms, variables, edit checks, and domain structure.
Integration-Ready Export
Builds export in your target EDC's native format: Medidata Rave builder XML, Oracle InForm study designer, Veeva Vault EDC, or generic ODM XML.
Detailed protocol parsing
What Concordare extracts
Protocols share structural categories. Concordare consistently locates and extracts them across sponsor formatting conventions.
- Visit schedule: names, windows, and required or optional assessments per visit
- Endpoint definitions: primary and secondary endpoints, methods, and collection timepoints
- Eligibility criteria: inclusion and exclusion rules structured as logic
- CRF requirements: data fields, measurement units, and allowed value ranges
- Protocol amendments: version history recorded as build deltas, not full reparse
Study team review
After parsing, your clinical data manager checks each extracted element against the source protocol. Changes log as user overrides, not system rewrites.
Confidence scores per element
Each parsed element receives a confidence score. Low-confidence items appear first in the review queue, directing team attention where needed.
Source traceability
Each generated element links to its protocol section. Reviewers can open the source PDF at the exact page with one click.
Structured database generation
A build matching your EDC's structure
Generated builds are not generic schemas. They use CDISC CDASH domain patterns and reflect your target EDC's conventions.
CDASH domain mapping
Forms and variables map to CDASH domains (AE, CM, LB, VS, EX, DS, and custom) from protocol endpoint and assessment definitions. Concordare follows CDASH patterns without claiming CDISC certification.
Edit check framework
The protocol's data collection requirements generate standard checks for visit windows, allowed ranges, required fields, and cross-form logic.
Variable naming conventions
Variable names use your organization's standard or the CDASH default. Workspace-level conventions apply across every build.
Integration-ready exports
Formats matched to your EDC
Choose your target system at export. No reformatting is needed on your end.
Medidata Rave builder XML
Export study designs in Medidata Rave's native format. Load directly into Rave Global Library or your sponsor-specific environment.
Oracle InForm study designer
Export in Oracle InForm's study designer format with form and variable definitions, visit schedules, and edit check logic.
Generic ODM XML
CDISC Operational Data Model XML (ODM XML) supports unnamed systems and any ODM-compliant EDC or import tool.
Built for data integrity
Protocol documents, no patient data
Study build protocols contain no PHI. Concordare processes document content and schema structure only. Patient records, lab results, and subject identifiers never enter the workflow.
Start your first build
Request early access and upload your first protocol. We will provide an export-ready build estimate in 48 hours.