Defined permissions
Align access and actions to roles, responsibilities, and authorized scope.
Governance & Compliance
Confidence comes
from controlled execution.
Connect access, approvals, traceability, and evidence to the work itself. Those controls can be tailored to your trial-specific workflows, processes, operational requirements, and governance.
Governance through the workflow
Every action has a controlled path.
Missing confirmation remains outstanding. Changes recalculate readiness while preserving the evidence and reason.
01
Scope
Study, country, site, subject, and role determine applicability.
02
Authorize
Defined permissions and approval rules control actions.
03
Execute
Separate recommendation, review, authorization, and execution.
04
Verify
Retain evidence, reasons, exceptions, and completion records.
Human approval
Review and approval gates can be tailored to the actions that require accountable decisions.
Traceable evidence
Connect records, document versions, completed training, and approvals to the process.
eTrialX Solution Foundation
An enterprise foundation.
A study-specific implementation.
eTrialX is built on an enterprise information and workflow platform with more than 30 years of market presence and deployment in regulated environments.
Controls follow intended use.
Implementation planning addresses applicable requirements such as 21 CFR Part 11, ICH-GCP, ALCOA+, Annex 11, and privacy obligations through configuration, procedures, and validation.
Platform-level security assurances and certifications must be evaluated for the selected services and deployment. They do not replace validation of the configured eTrialX solution.
AI governance
Human authority stays explicit.
Bounded access
Define the data and actions an AI capability can access for its intended purpose.
Reviewable outputs
Route relevant recommendations and prepared work to authorized people for review.
Intended-use validation
Evaluate workflows and AI capabilities for the specific context before relying on them.