One Integrated Platform for the Full Study Lifecycle
Trialhelix covers EDC configuration, IWRS/IRT randomization, CDISC SDTM data management, and TLF reporting — built as an integrated system, not a bundle of point tools.
Platform Modules
Each module is built to handle a specific study management function. They share a common data model and audit trail — no integration overhead between modules.
EDC & eCRF
Auto-generated eCRF forms from protocol documentation. 300+ validated edit checks. Visit schedule configuration. Signature workflows for data entry staff and monitors.
EDC moduleRandomization (IWRS/IRT)
Stratified randomization with block or minimization algorithms. Site-based drug supply management. Interactive web response system accessible to investigators.
Randomization moduleData Management
CDISC SDTM and ADaM mapping initiated at study build — not at data lock. MedDRA coding integration. Query lifecycle management. Pinnacle 21 validation checkpoint reporting.
Data Management moduleTLF & Reporting
Tables, listings, and figures generated from CDISC ADaM datasets. Output in SAS, R, and RTF formats. Statistical analysis plan linkage for DSMB-ready deliverables.
TLF & Reporting moduleWorks with Your Existing Clinical Systems
Trialhelix connects to tools your team already uses — without requiring full migration of your clinical data stack.
Pinnacle 21 Validation
Direct integration with Pinnacle 21 Community and Enterprise for SDTM and ADaM compliance validation. Reports are generated inside the platform — no manual CSV export and reimport.
MedDRA Coding Integration
Auto-coding against MedDRA dictionaries (current version maintained). Verbatim term mapping with coder review workflow. Coded terms flow directly to SDTM AE domain variables.
CDISC ODM Export
eCRF design exports in CDISC ODM-XML format. SDTM dataset exports in SAS Transport (XPT) and CSV. All exports maintain full metadata including variable labels and format specifications.
Protocol Management
Protocol document ingestion supports standard DMP templates. Protocol amendments are tracked with version history and impact assessment — which eCRF forms and edit checks are affected by a given amendment.
Why Integrated Beats Best-of-Breed for Phase I/II CROs
Many CROs assemble their clinical data stack from separate vendors — one EDC, one IWRS, one statistical reporting tool. This creates integration overhead: manual data transfers, reconciliation between systems, and audit trail gaps at system boundaries that inspectors notice.
Trialhelix starts from a different premise: the audit trail should be continuous. Every action — EDC entry, randomization event, query resolution, SDTM mapping decision — lives in the same timestamped record. When an FDA inspector asks "who changed this value and why," the answer is in one place.
For CROs running 3–8 concurrent Phase I/II studies, the platform overhead of managing multiple vendor contracts and integration points is itself a significant cost. Trialhelix reduces that overhead while increasing audit trail coherence.
Trialhelix is not an enterprise EDC platform designed for large-scale global studies across 50+ sites. It is designed for the operational profile of Phase I and II CROs: small study teams, 2–15 clinical sites, consultative sponsor relationships, and CDISC SDTM/ADaM delivery as the terminal output. That focus is intentional and maintained.
Walk Through the Platform on Your Study Design
A 30-minute technical call covers your specific indication, Phase, and EDC requirements. We will show you where Trialhelix reduces your team's configuration load and where it integrates with what you already have.