About Our Clinical Trial Logistics
Clinical trial specimens are a different category of work. A sponsor protocol typically defines a fixed transit window, a specific container type, a documented cold-chain configuration, and a chain-of-custody standard that must hold up under sponsor monitor review. A protocol deviation on transit can invalidate the enrollment data for that visit and, in some studies, trigger sponsor notification. Exodus Health Couriers serves Dayton-area clinical trial sites: academic medical-center research programs, hospital-affiliated oncology and cardiology research, pediatric research programs, and independent investigator sites across the Miami Valley. We handle specimen pickup from the site, IATA-compliant packaging where required, transport to the central or specialty lab on the sponsor's named carrier list, and full chain-of-custody documentation for the sponsor monitor binder. Diagnostic specimens that may contain a Category B infectious substance ship under UN3373 'Biological Substance, Category B' using IATA Packing Instruction 650 triple packaging: a leakproof primary receptacle, leakproof secondary packaging with absorbent material for liquids, and a rigid outer packaging with at least one 100 mm by 100 mm marked surface. The complete package passes a 1.2 m drop test, and for liquids the primary and secondary withstand 95 kPa internal pressure. Our drivers and dispatchers are trained on this packaging standard and on the IATA Dangerous Goods labeling requirements. Cold-chain configurations cover ambient, refrigerated (2 to 8 degrees C), frozen (-20 and -80 degrees C), and dry-ice with continuous temperature monitoring and logging. Temperature excursions are flagged and reported immediately. CDC clinical-specimen storage guidance recommends 1 to 10 degrees C with no freezing when prompt lab transfer is anticipated; we use that baseline plus the sponsor protocol's specific requirements. Documentation for the sponsor monitor includes pickup time and signature, in-transit temperature log, drop-off time and signature, tamper-evident seal status, GPS route history, and any exception events. The audit packet is available within the same business day on request.
What's Included
IATA UN3373 Packaging
Triple packaging per IATA Packing Instruction 650 for Category B diagnostic specimens: leakproof primary, leakproof secondary with absorbent, rigid outer with the required 100 mm by 100 mm marking surface.
Central-Lab Routing
Transport to the central or specialty lab on the sponsor's named carrier list. Handoffs to long-distance carriers are documented and temperature-monitored across the transition.
Sponsor-Grade Chain of Custody
Pickup time and signature, in-transit temperature log, drop-off time and signature, tamper-evident seal status, GPS route history, and exception events. Available within the same business day for monitor visits.
Cold-Chain Configurations
Ambient, refrigerated (2 to 8 degrees C), frozen (-20 and -80 degrees C), and dry-ice with continuous temperature monitoring. Excursions are flagged and reported immediately, not at month-end.
Protocol-Aware Dispatch
Dispatchers know your protocol's transit window, container requirements, and central-lab destinations. The driver assigned to your site is trained on the specifics of your study workflow.
Investigator-Site File Documentation
Driver training records, the executed Business Associate Agreement, insurance certificates, and packaging compliance documentation are filed and available for the investigator-site file and sponsor audits.
How Clinical Trial Logistics Works
- 1
Protocol intake
We review the protocol's transit window, container requirements, cold-chain configuration, central-lab destination, and documentation standard. The output is a site-specific procedure with a named dispatch contact.
- 2
Site setup
Driver assignment, packaging stock at the site if needed, label and barcode integration, and a dry run with the study coordinator to validate the handoff workflow.
- 3
Visit-day pickup
Driver dispatches to the site at the protocol-specified window. Pickup captures signature, photo, tamper-evident seal, and starts the temperature log if applicable.
- 4
Transport to central lab
Routing follows the sponsor's carrier list. For long-distance handoffs, the temperature log and chain-of-custody record carry across the transition. Exceptions are flagged immediately.
- 5
Documentation to investigator-site file
The complete audit packet flows to the investigator-site file. Sponsor monitor visit requests are fulfilled the same business day.
Available Across the Miami Valley
We offer clinical trial logistics in every city we serve. Pick yours:
Request Clinical Trial Logistics
Tell us about your facility's needs. We respond with custom pricing within one business day.