Forge the path to evidence.
The AI-powered workbench for protocol design, regulatory intelligence,
and trial operations. From first draft to submission-ready.
Interactive workspace preview
CRUCIBLE transformed how we approach protocol design. What used to take weeks now takes days, with better compliance and fewer amendments.
Dr. Sarah Chen
VP Clinical Operations, Global Pharma
500+
Clinical Trials
50+
Countries
99.9%
Uptime
From protocol design to submission, our platform streamlines every phase
AI-assisted protocol authoring that understands ICH E6(R3), therapeutic area nuances, and your organization's templates. Generate first drafts in minutes, iterate with your team in real-time.
Stay ahead with automated ICH E6(R3) checks, CDISC mapping, and real-time regulatory updates. Built-in audit trails and 21 CFR Part 11 compliance at every layer.
Transform complex study designs into interactive flowcharts, timelines, and dependency maps. Visualize patient journeys, protocol amendments, and operational workflows.
Generate deterministic UAT test cases from Excel codebooks. Parses field metadata, range checks, and mandatory flags to produce categorized test suites with ADO export.
3-layer QA validation pipeline: field verification from codebook rules, AI scenario tests from study XML, and NCDR gap analysis.
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, 21 CFR Part 11, and audit trails at every layer. Compliance isn't an add-on—it's foundational.
Trained on CDISC libraries, regulatory guidelines, and real-world study data—not generic content.
AI-assisted protocol authoring that understands ICH E6(R3), therapeutic area nuances, and your organization's templates. Generate first drafts in minutes, iterate with your team in real-time.
A dynamic workspace where XML schemas become interactive forms, study structures become navigable graphs, and every element is connected to its source of truth.
EDC Systems
Medidata, Veeva
CTMS
Oracle, Parexel
Regulatory
FDA, EMA
eTMF
SharePoint, Box
Analytics
PowerBI, Tableau
Cloud Storage
AWS, Azure
Leading organizations rely on CRUCIBLE for compliant clinical research
ISO 27001
Certified
GDPR
Compliant
FDA 21 CFR
Part 11
SOC 2 Type II
Audited
Multi-layered security with zero-trust architecture, end-to-end encryption, and continuous monitoring
Every request validated, no implicit trust
AES-256 encryption at rest and in transit
Real-time threat detection and response
End-to-end encryption, multi-factor authentication, and role-based access control. SOC 2 Type II certified.
Optimized for speed with global CDN, smart caching, and instant search. Sub-second response times.
Multi-region deployment with 99.99% uptime SLA. Built to handle enterprise-scale clinical trials.
Every feature engineered with compliance in mind. Trusted by top pharmaceutical companies and CROs.
21 CFR Part 11
FDA Compliant
CDISC
Standards Native
ICH E6(R3)
GCP Compliant
ISO 27001
Security Certified
HIPAA
Privacy Protected
SOC 2 Type II
Audit Verified
Join teams accelerating clinical trials worldwide
85%
Faster protocol development
12K+
Studies completed
99.9%
Regulatory compliance
24/7
Expert support
Start your free trial today. No credit card required.