H1ST-AI-DBD-001 · Task 1.1
Study build shouldn't swallow your timeline
The weeks you lose to form building — and the conformance risk baked in when they're rushed — don't have to define your build. The CRF Designer Agent generates Case Report Forms directly from the protocol, CDASH-compliant with edit checks and validation logic built in, cutting manual design effort by up to 70% while keeping downstream SDTM conformance clean from the start.
The grind you know
You know CRF design and edit-check programming are where the calendar disappears — weeks of painstaking form building and rule writing while everyone waits on the database. And you know the real cost isn't just time: one small conformance slip here quietly follows the data all the way to SDTM mapping and submission, where it's far more expensive to fix.
Part of the Database & Forms Design family
Protocol to CRF, ICF, SDTM & coding.
The weeks you lose to form building — and the conformance risk baked in when they're rushed — don't have to define your build. The CRF Designer Agent generates Case Report Forms directly from the protocol, CDASH-compliant with edit checks and validation logic built in, cutting manual design effort by up to 70% while keeping downstream SDTM conformance clean from the start.
The structured protocol from Protocol Intelligence drives form generation.
CDASH-compliant eCRFs, validation rules, and edit-check test cases are produced together.
Data managers review and adjust — in plain language via the Conversational Forms agent if desired.
Capabilities
Builds eCRFs from the structured protocol with support for multiple EDC platforms, stored in ODM-XML-compatible JSON/XML.
Maps every field to CDISC CDASHIG v2.1, so forms are conformant by construction and downstream SDTM mapping is clean.
Produces range checks, cross-field validations, and conditional logic from protocol requirements, with 50+ pre-configured rule types.
Auto-generates test cases for edit checks so the build can be validated before go-live.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
Enrollment is ready to go but everyone is waiting on the database while forms get built by hand. Starting from the structured protocol, the agent generates the CDASH-compliant eCRF set with validation logic in place, so the build stops being the bottleneck.
You know the manual builds where a systolic BP field ships with no plausible-range check and lets a 999 through. The validation-rule generator derives range, cross-field, and conditional checks from the protocol using 50+ pre-configured rule types, so the guardrails are there by construction.
Before you unlock the study you need evidence the edit checks actually fire. The agent auto-generates a test-case suite for the edit checks, so you validate the build against real scenarios rather than discovering a broken check once live data is flowing.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Medidata Rave
EDC
Oracle Clinical
EDC
Veeva Vault
EDC
Gemini / Anthropic LLM
LLM
Who it's for
Digitizes any protocol and extracts its structure — objectives, eligibility, and the schedule of assessments.
Learn moreAuto-generates SDTM annotations and the annotated CRF, Pinnacle 21-clean.
Learn moreEdit CRFs, validations, and ICFs with natural-language instructions — like ChatGPT for study build.
Learn moreAI-prompted, accessible data-capture components — sliders and scales for subjective assessments.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
