Real-Time Oversight of Your CRO's Data Operations
When your CRO uses Trialhelix, you gain structured access to study progress — query aging reports, SDTM delivery status, and audit trail summaries — without waiting for the weekly status call.
What Biotech Sponsors Need From Clinical Data
Visibility Without Interruption
Sponsors should be able to see data quality status without generating a CRO status report request. Monthly PDF summaries arrive too late to correct data collection issues while they are still recoverable.
Submission-Ready CDISC Output
Sponsors assume the CRO will deliver SDTM and ADaM datasets that pass Pinnacle 21 validation at data lock. In practice, late SDTM mapping creates a compressed delivery window that forces shortcuts.
Audit-Ready at Any Point
FDA inspections are not predictable. Sponsors need a CRO whose study data is inspection-ready throughout the study — not only during the two weeks before database lock when everyone scrambles.
Sponsor Transparency Features
When your CRO runs a study on Trialhelix, these capabilities are available to sponsor-designated observers by default.
Query Aging Dashboard
Live view of all open queries by site, form, and age — segmented by query type (edit check, manual, SDV). Sponsor observers can filter by severity category and export the aging report at any time.
SDTM Delivery Tracker
Real-time progress on CDISC SDTM domain mapping — which domains are complete, which are in draft, which require sponsor review. Updated automatically as the CDM team works.
Protocol Deviation Log
All protocol deviations entered in the EDC are reflected in the sponsor-visible deviation log with severity classification, site attribution, and resolution status.
Adverse Event Signal View
MedDRA-coded adverse events with CTCAE grade and expectedness classification. Sponsors can view the AE count by SOC and PT in real time — not waiting for a data lock TLF.
Audit Trail Export
The full system audit trail — every create, modify, and delete action with user, timestamp, and reason — is exportable in a structured format aligned with 21 CFR Part 11 audit trail requirements.
Role-Based Sponsor Access
Sponsor users are granted read-only observer access scoped to their study — no access to other CRO studies. Sponsor user roles are configured by the CRO project manager, not the Trialhelix admin. Trialhelix does not offer sponsors direct write access to clinical data — that channel remains with the CRO, consistent with the ICH-GCP E6(R2) sponsor oversight and delegation framework.
What Sponsors Can Request at Any Stage
Interim Data Extracts
Sponsors can request a point-in-time SAS or CSV extract of any CDISC domain — useful for DSMB reviews, interim analyses, and regulatory briefings. All extracts are audit-logged.
eCRF Design Review
Before study go-live, sponsors review the eCRF structure and edit check logic in a read-only approval workflow. The review record is stored as part of the study audit trail.
Data Review Meetings
Trialhelix supports sponsor-facing dashboard views specifically designed for bi-weekly data review meetings — site enrollment status, data entry completeness, and query resolution rates by site.
Pinnacle 21 Validation Reports
At any point during study execution, sponsors can request the current Pinnacle 21 compliance report for any SDTM domain. This provides ongoing confidence in CDISC conformance, not just a last-minute check.
Ask Your CRO About Trialhelix
If your CRO is not yet using Trialhelix, we can brief your team on what to ask for — and connect you with CROs in our network who run the specific study types you are planning.