Write-back Solutions
Close the loop by safely writing curated, governed insights back to operational systems such as EDC and CTMS. We implement API-first, auditable write-back patterns with proper gating, validation, and rollback to improve quality and operational efficiency.
EDC write-back
- Automated query creation for detected anomalies and reconciliation gaps
- Programmatic corrections with maker–checker approvals and traceability
- Derived flags (e.g., protocol deviations, risk signals) synchronized to forms
- SAE reconciliation status and queries synchronized to EDC
CTMS write-back
- Risk score updates to enable targeted monitoring and SDV/SDR strategies
- Visit scheduling and action items driven by centralized insights
- Milestone and enrollment forecast updates for portfolio planning
- Payment triggers and accrual adjustments with full auditability
Controls & validation
- Role-based gating and change control with approvals
- Idempotent APIs, retries, and rollback strategies
- Versioning, lineage, and end-to-end audit trails
Compliance-ready patterns
- 21 CFR Part 11–ready processes and documentation support
- Segregation of duties and controlled promotion workflows
- Runbooks for exception handling and inspection readiness
Design
Define eligible write-back actions, guardrails, and approval paths per system.
Implement
Build APIs, auditors, and monitoring; validate end-to-end with representative data.
Operate
24×7 monitored operations with approval logs, rollbacks, and reporting.
Enable safe, auditable write-back
Close the loop with governed updates to EDC and CTMS.