_Track.webp)
Stop chasing spreadsheets - start proving IMP integrity
IMP Track makes it easier to keep track of controlled evidence: who got the shipment, which lot number belongs to a visit, what the temperature was during transit, and how the kit was eventually destroyed.
IMP Track helps sponsors, CROs, and pharmacy teams keep large amounts of IMP records ready for inspection. When shipments are sent or kits are given to subjects, IMP Track automatically keeps track of where they are, keeps an eye on the temperature, and logs how they are used for reconciliation. This lowers the risk of supply chain waste and makes things clearer across locations and depots. It's designed to make being ready for an audit a regular thing: ship, track, dispense, and show proof.
- •Organizing shipments and assigning sites by role and region.
- •Controlled batch/lot traceability connected to records of kits, subjects, and visits.
- •Chain-of-custody evidence, temperature logs, and records of how things were disposed of are all available for audits and regulators.
IMP Track Features
IMP lifecycle automation, cold-chain assurance, and audit-grade traceability designed for regulated clinical supply management.
Automatic Shipment Orchestration & Tracking
Schedule and route IMP shipments automatically, track real-time GPS and temperature telemetry, and confirm delivery with time-stamped acceptance records.
Kit & Batch Traceability
Map kits to batch/lot numbers, expiry dates, and manufacturing records so every dispensed dose references the controlling batch and QC status.
Site Inventory & Dispensing Matrix
Maintain per-site inventory, dispensing logs, and subject-level kit assignments with automated re-order and resupply triggers.
Cold-Chain Monitoring & Excursion Management
Continuously monitor temperature telemetry, detect excursions, auto-notify stakeholders, and log corrective actions with evidence for inspectors.
Return, Quarantine & Destruction Workflows
Automate return authorizations, quarantine handling, and destruction records with photographed evidence and electronic sign-offs.
Randomization & Subject Kit Assignment
Integrate with IWRS/IVRS to allocate kits per randomization, log kit-to-subject linkage, and capture dispensing timestamps for subject visits.
Auditable Reconciliation & Discrepancy Resolution
Automate inventory reconciliation, surface mismatches, route queries to site pharmacists, and capture closure evidence for audit trails.
Integration & Data Flow
Bi-directional connectors for CTMS, EDC, IWRS/IVRS, QMS, and logistics vendors so supply evidence stays synchronized without manual reconciliation.
Compliance,
Security &
Validation Readiness
Built for regulated life sciences workflows with role-based access, secure audit trails, and electronic record controls designed to support GxP requirements and inspection expectations. We combine strong controls (roles, permissions, audit trails, Data integrity) with AI-assisted automation that reduces manual effort while keeping evidence complete.
- •Audit trail, traceability, and evidence-first workflows to support your validation/assurance approach (URS → risk → security test evidence).
- •Access control, segregation of duties, and configurable permissions.
- •Configurable workflows to match your SOPs and quality system.
Want to accelerate your rollout? We can provide a validation-ready evidence framework aligned to your SOPs.
IMP Track Use Cases
Designed for IMP distribution, cold-chain assurance, site resupply, and regulatory submission readiness.
Shipment & Depot Orchestration
Automate depot pick-pack-ship, route optimization, and proof-of-delivery for global IMP programs.
Site Resupply & Inventory Optimization
Forecast consumption, automate resupply, and prevent expiry-driven waste with real-time site dashboards.
Thermal Excursion Response
Detect temperature breaches in transit, trigger quarantine workflows, and document corrective actions with time-stamped evidence.
Randomization & Kit Assignment
Ensure kit allocation follows IWRS rules and capture immutable kit-to-subject records for study integrity.
Return Management & Destruction Proof
Standardize returns, record quarantine reasons, and produce signed destruction certificates for audit trails.
Regulatory Submissions & Import/Export Controls
Maintain customs, import permits, and regulatory paperwork mapped to shipments and batch records for inspections.
Frequently Asked Questions About IMP Track
CTMS manages trial operations and logistics like site activation and monitoring; EDC captures clinical data—IMP Track focuses on IMP supply, chain-of-custody, and kit-to-subject traceability.
IMP Track links kit allocations and dispensing schedules to the active protocol/visit version so shipments and subject assignments remain compliant after amendments.
Auditors expect batch/lot traceability, temperature logs, chain-of-custody records, dispensing timestamps, and reconciliation proof—all captured by IMP Track's audit trails.
Yes — IMP Track supports bi-directional integration with CTMS, EDC, IWRS/IVRS, QMS, and logistics vendors to keep supply evidence synchronized.
Yes — built for global supply operations with role-based access, country-specific import/export workflows, and centralized oversight across sponsors, CROs, and depots.
Ready to Automate IMP Supply Chain with Audit-Ready Evidence?
Get inspection-ready IMP Track evidence, cold-chain assurance, and real-time supply visibility across your trials.