Automated Logistics for Complex Trials
Decentralized protocols multiply the destinations a supply chain must reach: participant homes, sites, laboratories, and depots. Alethium delivers all of it within our CDP, so releases execute against protocol rules and custody is documented as it occurs.
Kitting, Packaging & Labeling
Participant kits designed, assembled, and labeled under GMP controls, with label design and translation for global studies.
Protocol-Driven Release
Shipments release only when eligibility and consent are confirmed. Unconsented participants never receive study supplies.
Comparator & Ancillary Sourcing
Comparator drug and ancillary supplies sourced, documented, and delivered through the same controlled flow.
Global GMP Depot Network
Receipt, storage, inventory, and distribution through GMP depots across major regions, with continuous monitoring and full reconciliation.
Temperature-Controlled Custody
Cryogenic (to –180°C), frozen, refrigerated (2–8°C), and controlled-ambient (15–25°C) shipping and storage, including cell and gene therapy logistics, with temperature monitored from packing through delivery.
Direct-to-Participant
Investigational product, kits, and devices delivered to participant homes and returned from them, with proof of delivery, prelabeled returns, and documented chain of custody. Release is gated on consent, and returns reconcile against the participant record.
Distributed Protocol Support
Decentralized and hybrid designs supply participant homes, sites, laboratories, and depots simultaneously. Every destination is governed by the same protocol rules and recorded in the same audit log, so a home delivery carries the traceability of a site shipment.
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Customs & Importer of Record
Import and export licensing, customs clearance, and Importer of Record services keep multi-country studies moving.
Built for Complex Protocols
Multi-arm and adaptive designs, cohort-specific kits, dose escalation, and blinded supply are handled as protocol logic rather than manual coordination. Expiry is tracked per lot and resupply triggers before a site runs short.
Sample Logistics
Biological samples travel under the same controlled custody from collection to central lab, with results flowing back into the study record.
Automated. On Time. Intact. Documented.
One partner, one supply chain, one audit trail.
FAQs - Common Questions
Decentralized protocols require simultaneous delivery to participant homes, sites, laboratories, and depots, each on a different schedule. Alethium governs every destination with the same protocol rules and records each movement in the same audit log, so a home delivery carries the same traceability and custody documentation as a shipment to a site.
Yes. Direct-to-participant shipping covers expedited and time-critical deliveries to homes and returns back from them, with proof of delivery, prelabeled returns, and documented chain of custody. Because logistics shares a platform with enrollment and consent, a shipment releases only after consent is confirmed.
Yes. Alethium manages import and export licensing, customs clearance, and Importer of Record services, which is often the blocker that stalls a first shipment into a new country. Biological samples are routed to central labs under the required permits and documentation.
Every custody handoff — depot receipt, pick and pack, dispatch, delivery, return — is captured as an event in the same immutable audit log that records consent and data capture. There is no separate logistics system to reconcile, so shipment history and participant history are one record.
Alethium supports cryogenic shipping and storage down to –180°C, frozen, refrigerated at 2–8°C, and controlled ambient at 15–25°C. Active and passive packaging is selected per lane, and temperature is monitored from packing through delivery so excursions are detected and product disposition is documented.
Release is gated on protocol events rather than manual checks. Behavior-Driven Development rules confirm eligibility and consent status before a shipment is triggered, and the release decision is written to the event-driven audit log. Unconsented participants cannot receive study supplies.
Yes. Comparator drug and ancillary supplies are sourced and documented, and participant kits are designed, assembled, and labeled under GMP controls, including label design and translation for global studies. Both flow through the same controlled supply chain as investigational product.