The AI-powered workbench for protocol design, regulatory intelligence, and trial operations. From first draft to validated ODM.
From protocol design to a validated study build, one workbench for every phase
AI-assisted protocol authoring that understands ICH E6(R3), therapeutic area nuances, and your organization's templates. Generate first drafts in minutes and iterate with your team.
Automated ICH E6(R3) checks and CDISC mapping while you design, so standards questions are answered where the work happens, not at submission.
Study designs become interactive forms, navigable graphs, and dependency maps, with every element connected to its source in the ODM.
Generate deterministic UAT test cases from Excel codebooks. Parses field metadata, range checks, and mandatory flags to produce categorized test suites with Azure DevOps export.
3-layer QA validation pipeline: field verification from codebook rules, AI scenario tests from study XML, and NCDR gap analysis.
Ask about ClinicalTrials.gov registries, PubMed literature, CDASH variables, or your own STRIDE study library, and get handed to the right tool when a conversation turns into a study.
Hand the study designer a brief, a protocol PDF, or an existing design to fork. It frames the shell, wires the forms and codelists, and keeps the output CDISC-clean.
A dynamic workspace where XML schemas become interactive forms, study structures become navigable graphs, and every element is connected to its source of truth.
CRUCIBLE is shaped by the practices that distinguish world-class clinical research organizations: relentless rigor, fast iteration, and a commitment to quality.
Every feature designed around actual clinical study workflows, not generic project management.
CDISC-native output that is validated before it ships. Nothing is exported that has not passed the validator.
Grounded in CDISC libraries, regulatory guidance, and your own STRIDE study library, not generic content.
SharePoint
Codebooks and study files
Azure DevOps
UAT test case export
Qualio
SOPs and controlled documents
STRIDE
Your study library
ClinicalTrials.gov and PubMed
Registry and literature search
SNOMED CT and ICD-10
Terminology lookups
The study designer speaks these natively, and validates against them before anything is exported.
CDISC ODM 2.0
Study structure
CDASH
Data collection
ICH E6(R3)
Guidance-aware
SNOMED CT
Clinical terms
ICD-10
Diagnosis codes
Single sign-on through Microsoft Entra ID, with workspace access limited to your organization's accounts.
Capabilities are granted per role, so each team member sees the tools and studies they are meant to.
Runs on Azure App Service, Azure Database for PostgreSQL, and Azure AI Foundry.
Crucible is available to 3PH Alliance and HRCRS teams. Sign in with your work account, or request access.