The study build process
Turn a protocol PDF into an EDC build
Four steps. The first three finish within 48 hours. The fourth is your team's review, completed in days, not weeks.
Getting started
Upload your protocol
Add your protocol PDF to the Concordare workspace, either as a new study or a new version of an existing one.
- PDFs up to 300 pages are supported. Longer protocols are accepted on request.
- Every upload creates a versioned record. For amendments, Concordare automatically identifies the prior version.
- Protocol documents contain no patient data. PHI never enters the processing pipeline.
- An email confirms upload and provides a build job ID for tracking.
Automated extraction
Parse and structure protocol elements
Concordare reads the protocol and extracts the structural elements required for the EDC build. Parsing finishes within hours of upload.
- Visit schedule: Extracts all visits, windows, and required assessments.
- Endpoint definitions: Captures primary, secondary, and exploratory endpoints and timepoints.
- Eligibility criteria: Converts inclusion and exclusion criteria into a reviewable structure.
- CRF requirements: Derives fields, units, ranges, and edit check logic from protocol text.
- Confidence scoring: Scores every extracted element and flags low-confidence items for priority review.
Study team review
Review, do not transcribe
The Concordare review interface places each parsed element beside its source section. Your clinical data manager verifies, edits, and approves it.
- Flagged items lead the queue, sorted by confidence score.
- Every element links to its source protocol page. One click opens that section.
- User overrides record every edit. Their history remains in the audit trail.
- Reviews that took 4-6 weeks now take 1-2 days for most standard protocols.
EDC-ready output
Export to your EDC system
After team approval, export the full study design package in your target EDC's native format.
- Medidata Rave: Rave Global Library XML with forms, variables, and checks.
- Oracle InForm: InForm study designer export with visit schedules.
- Veeva Vault EDC: Vault-compatible study design data.
- Generic ODM XML: CDISC-compatible for ODM-supporting system.
- The export includes a traceability report that connects each generated element to its protocol source.
Common questions
Frequently asked questions
Most protocols parse within 4-8 hours after upload. Complex protocols with adaptive designs or long appendices can take up to 16 hours. An email confirms completion and notifies you that the review queue is ready.
Concordare compares the new version with the approved prior build and creates a delta. The queue shows only changed elements. Unchanged elements carry forward without another review. For a standard amendment, this is typically 10-30% of the full build.
Concordare is trained on protocols from many sponsors and CROs, and most standard formats parse cleanly. Highly non-standard protocols, such as unusual section order, non-English text, or scanned PDFs, may generate more flagged items. During early access, our team reviews first builds to calibrate the system to your organization's protocol format.
The review interface allows multiple users. CDM team members can review separate domains, such as visit schedule and endpoints or labs and vital signs. Every override records the user ID and timestamp for the audit trail.
Concordare builds the EDC database structure. It does not review protocol design, validate the clinical study design, or replace clinical data manager judgment. Your team reviews and approves the structured starting point before EDC load. Concordare does not manage patient data, study conduct, or post-build data collection.
See it on your protocol
Request access and submit your first protocol. We will return a build estimate within 48 hours so you can assess fit before a full build.