CRF Specification Builder
CDASH CompliantCreate protocol-driven CRF specifications with automated CDASH compliance and domain-specific validation rules — eliminating manual rework.
DataOrbix transforms fragmented clinical streams into a singular, high-fidelity source of truth. Precision data management for the next era of research.
DataOrbix is redefining how clinical teams design, govern, and accelerate research data — converging intelligent workflow automation, real-time data oversight, and AI-driven clinical insights into a single, audit-ready platform. Be among the first to experience next-generation CDISC-compliant CRF design and DORI-powered intelligence.
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Create protocol-driven CRF specifications with automated CDASH compliance and domain-specific validation rules — eliminating manual rework.
Map variables seamlessly between CDASH and SDTM with intelligent suggestions, automated validation, and complete traceability matrices.
Generate fully responsive eCRFs with real-time live preview, conditional logic execution, and comprehensive field validation.
Build complex skip patterns and field dependencies using a visual designer with automated rule testing and conflict detection.
Comprehensive audit trails, electronic signatures, and access controls designed for 21 CFR Part 11 and GxP compliance environments.
Powered by Data Orbix Reasoning Intelligence — DORI provides contextual guidance, automated suggestions, and intelligent compliance checks.
A structured, standards-first workflow that eliminates rework and accelerates regulatory submission timelines.
Import your clinical protocol and auto-extract parameters, visit schedules, and data requirements.
Choose from CDISC-compliant templates and standard libraries for your therapeutic area.
Configure domains, variables, and validation rules with automated CDASH compliance checks.
Create comprehensive CRF specifications with automated validation and compliance scoring.
Build interactive eCRFs with conditional logic, skip patterns, and live validation previews.
Add edit checks, finalize approval workflows, and deploy with complete audit trails and documentation.
Traceability from protocol to eCRF, with alignment to every major regulatory framework in clinical research.
Full compliance with CDISC standards including CDASH, SDTM, and ADaM for seamless regulatory submission — with automated gap detection and mapping verification built directly into the platform workflow.
Complete traceability matrix from protocol requirements through CRF specifications to final eCRF implementation.
Electronic records, signatures, and audit trails designed to support Part 11–compliant validation environments.
Pre-validated per GAMP 5 guidelines with complete documentation packages and testing protocols.
Hear what data managers, CDEs, and CRO teams say about DataOrbix in their workflows.
"DataOrbix cut our CRF specification build time by more than half. The automated CDASH mapping alone saves our team weeks of manual effort per study."
"The domain mapping verification module is outstanding. We caught SDTM inconsistencies before they reached the submission package — a game changer for our QA process."
"DORI's AI-driven suggestions during CRF configuration are incredibly accurate. It's like having a CDISC expert embedded directly in our workflow."
Streamline your clinical trial data design with enterprise-grade CDASH/SDTM mapping, dynamic eCRF rendering, and regulatory compliance — all in one unified platform.
Contact DataOrbix for enterprise pricing and implementation details
We build precision data infrastructure at the intersection of AI and clinical research. Join a founder-led team operating at the frontier — where the standards are high, the autonomy is real, and the work moves the needle on how the world runs clinical trials.
The Mission
Solving high-stakes data routing, regulatory compliance architecture, and clinical standards at a depth that pushes what's technically possible.
The Culture
A fast-paced, founder-led environment built on cutting-edge AI and data engineering tooling. We move fast, ship with precision, and trust our people to own their domain.
The Impact
Empowering global sponsors and CROs to run faster, safer, more compliant clinical trials. Your work reaches research teams across continents and therapeutic areas.
Design, build, and scale data pipelines and AI-driven modules that power our CDASH/SDTM mapping engine and clinical data intelligence layer. You'll work across Python, cloud infrastructure, and LLM orchestration frameworks in a high-trust, high-impact environment.
Own the product roadmap for our core CRF specification and domain mapping modules. You'll work closely with clinical data managers, sponsors, and our engineering team to translate complex regulatory requirements into elegant, high-utility features that ship on time.
Bridge clinical domain expertise with our AI-driven compliance engine. You'll validate CDISC standard mappings, contribute to our regulatory knowledge base, and guide the design of intelligent edit checks that protect data integrity across global trials.
Don't see your role? Send us your profile — we're always open to exceptional people.