Subject Management Module
End-to-end control of subject lifecycle from screening to study completion.
Subject Management
SyMetric Solutions
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Key Capabilities
Subject Management Configuration
Define study-specific rules for eligibility, stratification, treatment balancing, visit planning, and duplicate subject controls to ensure protocol adherence from the start.
Subject Identification & Metadata
Uniquely identify subjects with configurable numbering rules. Metadata validation ensures compliance with age, gender, stratification, and duplicate rules.
Subject Visits
Manage the complete visit lifecycle, from automatic display of planned visits to handling early, late, skipped, or repeated visits with full audit trails.
Subject Screening
Record screening outcomes across configured visits, with support for re-screening and automated notifications to keep your trial on track.
Subject Enrolment
Manage enrolment outcomes with validation against study and stratification caps, ensuring balanced and compliant trial populations.
Subject Randomization
Utilize a robust, regulatory-compliant engine with support for system-generated or pre-generated randomization, treatment balancing, and various blinding modes.
Drug Dispensing
Ensure compliant dispensing aligned with IWRS rules, inventory awareness, and controls for active, valid, non-expired stocks.
Drug Receipts
Record the collection of used or unused drug packs with visit-level configuration, reason capture for non-returns, and full audit trails.
Subject Withdrawal
Securely record subject withdrawal with date and configured reasons. All further transactions are automatically disallowed post-withdrawal.
Subject Unblinding
Perform unblinding with strict, role-based controls, mandatory reason capture, and an optional approval workflow to maintain study integrity.
Subject Study Completion
Record study completion with selectable outcomes, enforcing mandatory visit completion and maintaining full compliance documentation.
Subject Replacement & Revert
Replace subjects while maintaining treatment arm integrity, and use role-based controls to revert stratification or other flags with complete audit trails.
Summary
The Subject Management module delivers a complete, compliant, and highly configurable ecosystem for managing subjects across the entire study lifecycle. It ensures accuracy, protocol adherence, regulatory completeness, and operational efficiency—whether your study has 20 subjects or 20,000 across multiple regions.