Stratified Randomization Integrated with Your EDC
The Trialhelix IWRS/IRT module handles treatment assignment, drug supply management, and unblinding procedures — with every randomization event written to the study audit trail.
Randomization Features for Phase I and II Studies
Multiple Randomization Algorithms
Simple block randomization, stratified block randomization, and minimization (dynamic) algorithms. Stratification factors are drawn from EDC screening data — no manual re-entry of baseline variables.
Drug Supply Management
Site-level inventory tracking with resupply trigger thresholds. Drug kit assignment is tracked to individual subject and visit. Expiry monitoring with automated alerts to site coordinators.
Blinding & Unblinding Controls
Treatment arm codes are stored with dual-key encryption. Emergency unblinding procedure is logged with user identity, timestamp, and reason. Unblinding events are immediately visible to the sponsor observer role.
Interactive Web Response
Investigators access the IWRS through a browser — no app install required. Randomization and dose escalation decisions are recorded with site time and system time. Mobile-accessible for site coordinators.
Adaptive Design Support
Rule-based cohort expansion and dose escalation decisions for Phase I adaptive designs. DSMB-facing summary reports generated from IWRS assignment and safety data at scheduled review points.
Randomization Audit Trail
Every IWRS event — subject screening, randomization, dose assignment, drug dispensing, and protocol deviation — is captured in the study audit trail with the same timestamp precision as EDC events.
Randomization Module Capabilities
Discuss Your Randomization Design
Phase I dose escalation and stratified Phase II randomization have different IWRS requirements. Bring your protocol and we will walk through the configuration approach.