Study Build & Design · H1ST-AI-DBD-001
Protocol to CRF, ICF, SDTM & coding.
The problem this family owns
This is the repetitive, deadline-bound stretch of the trial where a small error gets expensive to fix later. A stretched team feels it here first.
The Database & Forms Design family puts a purpose-built agent on each of these. You stay in control of every output. The agents absorb the grind, not the judgment.
Where it fits
The study-build engine. Database & Forms Design interprets the protocol and generates the data-collection layer (eCRFs, validation rules, informed consent, SDTM annotations, and smart form components) so a study is ready to capture data in days, not months.
It sits in the Study Build & Design suite (turn a protocol into a ready-to-run study) and ships as 7 AI agents you can adopt one at a time or run as a complete workflow.
The agents
Each agent below removes a specific piece of that grind. Deploy the whole family as one workflow, or add the single agent that hurts most today and expand from there.
Digitizes any protocol and extracts its structure: objectives, eligibility, and the schedule of assessments.
Learn moreTurns a protocol into CDASH-compliant eCRFs with edit checks and validation rules.
Learn moreGenerates ICH-GCP-compliant informed consent forms at an 8th-grade reading level.
Learn moreTranslates informed consent into 30+ languages with back-translation verification.
Learn moreEdit CRFs, validations, and ICFs with natural-language instructions, like ChatGPT for study build.
Learn moreAuto-generates SDTM annotations and the annotated CRF, Pinnacle 21-clean.
Learn moreAI-prompted, accessible data-capture components: sliders and scales for subjective assessments.
Learn moreOne workflow, not point tools
Enabled together, the Database & Forms Design agents hand off in sequence. Each one's output feeds the next, so nothing gets re-keyed and nothing slips between the seams.
Digitizes any protocol and extracts its structure: objectives, eligibility, and the schedule of assessments.
Turns a protocol into CDASH-compliant eCRFs with edit checks and validation rules.
Generates ICH-GCP-compliant informed consent forms at an 8th-grade reading level.
Translates informed consent into 30+ languages with back-translation verification.
Edit CRFs, validations, and ICFs with natural-language instructions, like ChatGPT for study build.
Auto-generates SDTM annotations and the annotated CRF, Pinnacle 21-clean.
AI-prompted, accessible data-capture components: sliders and scales for subjective assessments.
Built for regulated trials
Every agent runs inside a validated, audit-ready platform aligned to the standards clinical teams and inspectors expect.
Electronic records and signatures with full audit trails, access controls, and validation.
Good Clinical Practice, including risk-based quality management and computerized-system expectations.
Standards-based data capture, tabulation, and analysis datasets that validate clean in Pinnacle 21.
PHI safeguards, de-identification, and role-based access across the platform, with a signed BAA for every healthcare entity we work with.
Breach-notification and enforced-security obligations that extend HIPAA to us as your business associate.
Lawful processing, data-subject rights, and EU data-residency support for global trials.
Security, availability, and confidentiality controls audited against Trust Services Criteria.
Certified information-security management system governing the whole platform.
AI management system for responsible, governed, and auditable use of AI.
Straight answers
Pulled from the questions teams ask most about the agents in this family, answered plainly, including where the honest answer is a limit.
No pitch, no pressure. Just a working walkthrough on your own workflow, with honest answers about where the limits are. Bring the study that worries you most.
