How CRO Teams Use Trialhelix Across the Study Timeline
Platform features describe what the system does. Workflows describe how your team uses those features — from the day a protocol is received to the day the CDISC dataset package ships to the sponsor.
From Protocol Receipt to Regulatory Submission
Each lifecycle phase corresponds to a Trialhelix workflow. Click any phase to see the detailed workflow documentation.
Study Build
Protocol ingestion, EDC configuration, edit check setup, IWRS randomization configuration, and CDM review approval. Study build completed in 4–6 days.
Study Build workflowSite Monitoring & SDV
Source document verification workflow, SDV completion tracking per site and visit, query generation from SDV findings, and CRA visit report generation.
Site Monitoring workflowAdverse Event Reporting
AE capture with MedDRA coding, CTCAE grading, SUSAR and SAE expedited reporting workflows, and sponsor safety report generation.
AE Reporting workflowData Lock & Reconciliation
Pre-lock data reconciliation checklist, database lock signature workflow, SDTM and ADaM final validation, and TLF delivery package assembly.
Data Lock workflowEach Workflow is Role-Specific
Trialhelix workflows are documented from the perspective of the CRO role who executes them — not the platform feature that supports them.
Study Build — CDM Lead
The CDM lead receives the protocol, initiates EDC configuration in Trialhelix, reviews the generated eCRF structure, and approves the build for go-live. Timeline: 4–6 business days from protocol to first site access.
Full workflowSite Monitoring — CRA
The CRA uses Trialhelix to plan monitoring visits, record SDV completions, generate queries from source discrepancies, and produce the monitoring visit report — all within the study audit trail.
Full workflowAE Reporting — Safety Data Manager
The safety data manager monitors adverse event capture, ensures MedDRA coding is complete, reviews expedited reporting triggers, and produces the SAE narrative package for sponsor safety review.
Full workflowData Lock — CDM Lead + Biostatistician
Data lock is a multi-role workflow: CDM lead completes the pre-lock reconciliation checklist; biostatistician validates the SDTM and ADaM package; both sign the database lock certificate.
Full workflowWalk Through a Study Workflow
A 30-minute call can cover one complete workflow — from protocol to data lock — on a study type similar to yours. We can show you where automation reduces manual time and what the CDM still owns.