Clinical trial automation, built for CRO operations
Six integrated modules that eliminate the manual coordination work between protocol upload and data lock — without replacing your existing CTMS.
Legacy CTMS platforms were not designed to automate
Biotech CROs and mid-market pharma sponsors running Phase I–III clinical trials carry a disproportionate operational burden that is invisible in most product conversations. Clinical operations teams lose weeks to manual coordination across protocol amendments, site activations, and data query resolution — work that legacy CTMS platforms were never designed to automate.
A mid-trial protocol amendment across 14 active sites does not just mean updating one document. It means re-training coordinators at every site, manually propagating changes to eCRF field definitions, updating adverse-event signal rules, and chasing acknowledgment signatures from investigators who have other priorities. No existing system traces how a single protocol change ripples downstream across every site, form, and data point simultaneously.
The result is not just delay — it is compounding risk. Unresolved data queries accumulate until data lock. Missing regulatory documents surface during sponsor audits rather than before site activation. Safety signals go undetected until the weekly data review rather than appearing when data arrives. Each of these is a solvable problem with the right automation layer.
The cost of manual coordination
3–8 weeks of site activation delay per protocol amendment in organizations using manual amendment propagation workflows.
2–4 months of data-lock lag attributed to unresolved queries and missing audit trails in manual workflows at specialty CROs.
6 weeks is the standard manual eCRF build cycle that Trialhelix protocol parsing replaces with an automated schema output.
Lean teams of 3–12 clinical operations staff managing 3–20 concurrent trials bear the majority of this coordination burden.
From protocol document to production-ready trial
No lengthy implementation projects. Trialhelix connects to your existing CTMS via API or CSV export and begins automating from the first protocol upload.
Protocol Upload and CTMS Connection
The sponsor or CRO uploads the study protocol document — PDF or DOCX — and connects the existing CTMS via API or CSV export. Trialhelix does not replace the CTMS; it automates the configuration and monitoring work that sits above it. Connection to Medidata Rave, Veeva Vault, Oracle CTMS, and REDCap is supported through pre-built integration adapters. Initial setup typically requires less than a day of CRO operations time.
Automated Schema Generation and Rule Configuration
Trialhelix parses the protocol's structure and generates a fully annotated eCRF schema with field-level validation rules, skip logic, and data-type constraints. Adverse-event signal rules are configured directly from the protocol's SAE definitions. Data-query routing logic is mapped based on site role assignments. Every configuration step that clinical operations teams currently perform manually is handled without human intervention. Protocol amendments propagate automatically to downstream eCRF fields and rule sets.
Production-Ready Trial Infrastructure
The output is a production-ready clinical trial environment: validated eCRF templates with audit-compliant field definitions, a live enrollment dashboard aggregating data across all sites, an automated query resolution queue routing routine data questions to the correct site contact with pre-drafted templates, and a GxP-compliant immutable audit log formatted for FDA 21 CFR Part 11 submission. Medical monitors receive real-time adverse-event signal alerts within hours of data arrival rather than at the weekly review cycle.
Capabilities that cover the full trial lifecycle
Each module addresses a specific category of manual work that stalls clinical operations. Use all six or integrate selectively alongside your existing tools.
Protocol-to-eCRF Generation
Trialhelix ingests your protocol document and outputs a fully annotated eCRF schema with field-level validation rules, skip logic, and data-type constraints — eliminating the six-week manual build cycle your data management team currently owns. Changes to the protocol propagate automatically to downstream eCRF fields, so amendment ripple-through is handled without a second round of manual configuration.
Automated Site-Readiness Checks
Before a site goes live, Trialhelix cross-references every document in the site activation package against the protocol’s regulatory checklist. Missing IRB approvals, expired investigator CVs, or incomplete essential documents surface as actionable items — not discovered three weeks later during a sponsor audit. Sites do not activate until the regulatory document set is complete, reducing post-activation corrective action cycles.
Adverse-Event Signal Detection
As data flows in from sites, Trialhelix applies configurable safety rules derived directly from the protocol’s SAE definitions. Potential signals are surfaced within hours, not after the next weekly data review — giving medical monitors the lead time they need before regulatory reporting windows close. Signal rules are versioned alongside protocol amendments, so updated SAE definitions take effect immediately.
Real-Time Enrollment Tracking
Trialhelix aggregates enrollment data across all sites into a single operational view. Screen-fail patterns trigger early warning flags, allowing CROs to escalate site support or adjust inclusion criteria before enrollment falls behind schedule. Projected completion recalculates daily using current-pace modeling, giving sponsors and CROs a forward-looking view rather than a retrospective enrollment report.
Query Auto-Resolution
Routine data queries — range violations, missing fields, date logic errors — are automatically routed to the correct site contact with a pre-drafted resolution template. Sites resolve queries in hours instead of days, and the audit trail captures every response for regulatory inspection readiness. Non-routine queries that require clinical judgment are escalated to the appropriate medical monitor or data manager.
GxP-Compliant Audit Trail
Every action on the Trialhelix platform — protocol change, eCRF edit, query response, site communication — is captured in a tamper-evident audit log with user attribution, timestamp, and reason-for-change. The log exports directly into FDA-ready format, reducing inspection prep time from weeks to hours. The audit trail meets FDA 21 CFR Part 11 and ICH E6(R2) GCP requirements as a built-in platform property.
Works alongside your existing clinical stack
Trialhelix connects to the platforms your CRO already uses via pre-built integration adapters. No CTMS replacement required.
Regulatory requirements built into the platform
FDA, ICH, and HIPAA compliance are architectural constraints at Trialhelix, not documentation deliverables added after the fact.
FDA 21 CFR Part 11
Electronic records and electronic signatures compliant. Tamper-evident audit log with user attribution and reason-for-change on every action.
ICH E6(R2) GCP
Good Clinical Practice requirements for trial conduct, data integrity, and investigator oversight are embedded in platform workflows.
HIPAA-Compliant Data Hosting
All data is hosted on Microsoft Azure with HIPAA BAA coverage. PHI is encrypted at rest and in transit. No trial data leaves HIPAA-compliant infrastructure.
Lean clinical operations teams managing concurrent trials
Trialhelix is built for CROs and biotech sponsors managing 3–20 concurrent Phase I–III trials with lean operational teams. The primary customer is a specialty CRO with 10–200 staff and $5M–$100M in revenue running studies where every week of site activation delay and every month of data-lock lag has a material impact on client relationships and trial timelines.
Biotech sponsors who run trials in-house with small clinical operations functions also benefit from the protocol-to-eCRF and audit trail modules, particularly sponsors preparing for first FDA submissions who need to establish compliant electronic records infrastructure without hiring a full data management department.
The ideal Trialhelix team is one where the same person who manages site activations also tracks enrollment, resolves queries, and prepares regulatory submissions — and where that person is looking for a tool that handles the coordination work so they can focus on the clinical judgments that require human expertise.
Who Trialhelix is not designed for
Large CROs with fully staffed data management departments already deeply invested in Medidata Rave customization and internal CTMS tooling are not the right fit for Trialhelix at this stage. The platform is designed to operate alongside — not replace — enterprise CTMS, but organizations with dedicated configuration teams and established Rave workflows will find less marginal value from the automation layer.
Early pre-clinical stage companies with no active IND or companies still in drug discovery are also outside the current scope. The platform is designed for organizations that are actively running trials with enrolled patients, not for pipeline management or pre-clinical data capture.
Large enterprise CROs with fully staffed data management teams · Pre-clinical stage companies with no active IND · Organizations requiring on-premise deployment
Ready to cut your site-activation timeline?
Trialhelix is currently onboarding design partners from specialty CROs and lean biotech sponsors in the US.