A cold-chain courier fleet staged under lights before a night dispatch.

Cold-chain transport for time-critical medical cargo

BioChain moves organs, mRNA vaccines and radiopharmaceuticals across the Mid-Atlantic under continuous temperature telemetry and biometric chain of custody. Every consignment closes with an audit pack a regulator can reproduce.

99.99%On-time SLA target
0Excursion tolerance
24/7Dispatch monitoring
GDPGood Distribution Practice across the full chain
21 CFR Part 11Electronic records and signatures
FedRAMP-compliantCloud deployment for federal workloads
Zero-trustNo standing access, and every read is logged

Temperature bands and viability windows

A biological asset has a temperature band it must never leave and a viability window that started before you took possession. ColdLink plans the route against both limits at the same time.

Temperature band
2–8 °C

Hypothermic preservation. Organs in static cold storage, blood products, most biologics.

−20 °C

Frozen. Reagents, plasma derivatives, certain investigational products.

−70 °C

Ultra-cold. mRNA vaccine stock and dry-ice shipping configurations.

Dispatch is alerted as a cooler approaches its threshold, not once it has breached it. Dispatch therefore has time to reroute or fix the hardware before the temperature goes out of range.

Viability window
4–6 h

Heart, lung. The shortest window among the organs listed.

8–12 h

Liver. Cold ischemia time sets the limit for the route.

24–36 h

Kidney. The longer window is monitored the same way.

110 min

F-18 radiotracer half-life. Radiopharmaceuticals decay in transit, so the dose that arrives is lower than the dose that left.

The custody chain, from intake to proof

Four stages, each one binding a person, a time and a temperature to an immutable record, with no manual entry by the courier.

A courier taking possession of a sealed medical transport case at handover.
INTAKE

The route is calculated and the delivery time is committed

A hospital raises a transport request in the client portal. ColdLink builds the route against live I-95 conditions, weather, and the specific viability window of the asset, then commits to a delivery time rather than an estimate.

Client portalTraffic + weatherCommitted window
CUSTODY

The signature identifies the courier who took possession

The courier authenticates biometrically at pickup. That electronic signature binds directly to the record state, giving a traceable, immutable custody transfer that satisfies FDA requirements for closed systems.

Face ID / Touch IDNFC seal scan21 CFR Part 11
TELEMETRY

The cooler is monitored throughout the journey

Bluetooth sensors inside the cooler stream internal temperature and location for the whole journey. Drift toward a threshold raises a dispatch alert while a reroute is still possible.

IoT cooler sensorsLive GPSThreshold alerting
PROOF

The consignment closes as an audit pack

The recipient signs, and delivery generates a compliance pack containing the full temperature trail, the signature log and the system access log. It is built to be reproduced on demand for inspection, months later, without anyone reconstructing it by hand.

Temperature trailSignature logAccess log

What the courier, dispatch and audit teams see

The courier's phone, the dispatch floor and the audit console all write to the same consignment record, so nothing has to be exported from one and merged into another.

Courier application, offline first

Hospital basements and loading docks often have no signal, so the app is built to work without one. Biometric sign-offs and NFC seal scans complete locally and sync the moment the handset reconnects.

  • iOS and Android, built for glove-and-cold-room use
  • Queued writes are stored on the handset and survive a power loss

Dispatch telemetry matrix

A live map of every active cooler, its GPS position and its internal temperature, watched around the clock by dispatchers who act on exceptions.

Admin audit console

Export a tamper-evident trail of every system access and every data modification. Built for the closed-system requirements a federal or hospital auditor will test, and available without raising a support ticket.

  • Filtered by consignment, user or date range before export
  • MFA enforced on the portal; zero-trust between services
Dry-ice vapour rolling off an ultra-cold shipping container.
The interior of a validated medical transport case, partitioned and instrumented.
CONSIGNMENT SEALEDTRAIL COMPLETE

Contents of the audit pack

Every BioChain consignment closes with the same pack in the same format, and it can be reproduced on demand.

  • Continuous temperature trail for the full journey, timestamped, with any threshold approach and the action taken
  • Biometric signature log for every custody transfer, bound to the consignment record
  • System access and modification history, satisfying closed-system expectations under 21 CFR Part 11
  • Proof of delivery with recipient signature, included in the same pack
Mid-Atlantic

The corridor we cover

BioChain operates from Columbia, Maryland, sitting on the I-95 stretch between Baltimore and Washington. Federal health agencies, academic medical centres and biotech laboratories cluster along that corridor, and traffic on it is one of the inputs ColdLink routes against.

Dispatch runs continuously. Couriers are trained in biological material handling and hold the credentials the receiving facility will ask for at the dock.

Served metros
Baltimore, MDI-95
Washington, DCI-495
Northern VirginiaI-495
Wilmington, DEI-95
Philadelphia, PAI-95
Richmond, VAI-95

Questions before a first shipment

What happens when a cooler drifts toward its threshold?

Dispatch is alerted while the asset is still in band, not after a breach. A dispatcher assesses the route and acts immediately where a reroute or a hardware intervention preserves the consignment. The approach, the alert and the action are all written into the audit pack, so the record shows the excursion was prevented rather than simply not reported.

How is chain of custody proven for a regulator?

Every transfer is a biometric authentication bound to the record state at the moment it happens, which is what FDA 21 CFR Part 11 asks for in a closed system. The biometric authentication is itself the signature, so there is no scanned image to store. Combined with the continuous temperature trail and the system access log, it produces a pack that can be reproduced on demand for inspection.

Can couriers complete sign-off without cellular reception?

Yes. The courier application is offline-first by design, because hospital basements, loading docks and cold rooms routinely have no signal. Biometric sign-offs and NFC seal scans complete on the handset and cache locally, then synchronise automatically on reconnection with their original timestamps intact.

What does a compliance audit and SLA review involve?

We review the assets you move, the temperature bands and viability windows they demand, your receiving facilities and your own regulatory obligations. You get back a written service level agreement with committed delivery windows, plus a sample audit pack in the exact format your inspectors would receive. There is no charge for the review.

Request a compliance audit and SLA.

Tell us what you move and where it has to be delivered. You will get a written SLA with committed windows and a sample audit pack in the format your inspectors would see.

Already a client? Sign in to the client portal. Portal access is protected by multi-factor authentication.

The review is free. We reply within one business day.