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Clinical Trial Data Management Resources
Practical content for clinical data managers and CRO operations teams: whitepapers on CDISC automation, study build guides, and technical blog posts covering EDC and Phase I/II data workflow.
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Whitepapers & Guides
In-depth technical guides on CDISC SDTM automation, EDC configuration, and 21 CFR Part 11 readiness. Designed for clinical data managers evaluating automation tools.
Blog
Technical perspectives on query cycle time, data lock procedures, IWRS integration, and audit trail configuration. Written by CDMs for CDMs.
Technical Calls
Schedule a direct technical call with the Trialhelix team. Bring your protocol — we will walk through how our platform maps to your study build workflow.
Featured Whitepapers
Guides for CRO Data Teams
Reducing Query Cycle Time in Phase II EDC Configurations
Request guideCDISC SDTM Automation: A Practical Guide for Biotech CROs
Request guide21 CFR Part 11 Readiness Checklist for Phase I Studies
Request guideAll guides are provided to CRO and sponsor teams on request. Contact us or view all whitepapers.
Recent Blog Posts
Latest from the Trialhelix Team
CDISC SDTM Automation: Moving Beyond Manual SAS Programming in Phase I Trials
Manual SDTM mapping remains one of the largest time sinks in Phase I study closeout.
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What Drives Query Cycle Time in EDC Systems — and How to Reduce It
Query cycle time is a reliable leading indicator of study execution quality.
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Data Lock Best Practices for Phase II Trials: A Clinical Data Manager's Checklist
A clean first-pass data lock depends on preparation that begins at study build.
Read articleQuestions About Your Study Workflow?
We run direct technical calls with clinical data managers. Bring your specific EDC or CDISC challenge and we will work through it with you.