Whitepapers & Guides
Technical Guides for Clinical Data Teams
In-depth technical content on CDISC SDTM automation, EDC configuration, and regulatory readiness for CRO data managers and trial operations teams running Phase I and II programs.
Available Guides
Clinical Data Management Resources
These guides are written for CRO data managers and trial operations leads. Each covers a specific operational challenge in Phase I and II study execution.
Reducing Query Cycle Time in Phase II EDC Configurations
Query cycle time is a reliable leading indicator of study execution quality. This guide covers the structural EDC configuration decisions — edit check design, discrepancy workflow routing, site user permission scoping — that most directly reduce open query volume and resolution time in Phase II multi-site studies.
CDISC SDTM Automation: A Practical Guide for Biotech CROs
Manual SDTM mapping is consistently one of the largest time sinks in Phase I study closeout. This guide covers domain-by-domain mapping strategy (DM, AE, CM, LB, VS, EX), automated derivation rules, and the practical difference between annotation-based and metadata-driven SDTM approaches for small CROs without a dedicated SAS team.
21 CFR Part 11 Readiness Checklist for Phase I Studies
A practical readiness checklist organized by the five core compliance areas: audit trail completeness, electronic signature alignment, access control configuration, system validation documentation, and data integrity controls. Formatted for clinical data managers to use during EDC vendor evaluation or pre-inspection preparation.
All guides are provided to CRO and sponsor teams on request. We send the PDF directly — no marketing list. Contact the Trialhelix team to receive any guide within one business day.
Not Finding What You Need?
Technical questions are better answered on a call
If you have a specific protocol challenge — audit trail scope, SDTM domain mapping question, IWRS configuration, or data lock process design — the Trialhelix team runs direct technical calls. Bring your protocol and we will work through it.
Evaluating EDC or CDISC Automation Tools?
Trialhelix works with CRO data teams to reduce manual overhead from protocol design through CDISC delivery. Start with a technical call — no sales pitch, just your workflow questions.