Product
Transport for clinical trials and investigational medicinal products
Investigational product, kits and trial material to sites, CROs and CDMOs, with temperature control, a record per shipment and the reinforced traceability required by a product that exists in few units and has no replacement.
What makes clinical trial transport different?
The product is irreplaceable and the calendar cannot move. A batch of investigational medicinal product (IMP) is not re-manufactured to replace a lost shipment, and the patient visit that depends on it has a date. The framework is Regulation (EU) 536/2014 on clinical trials and, in transport, the same thermal and documentary requirements as GDP.
- Irreversibility
- There is no safety stock. An excursion does not mean re-supply: it often means losing units from the trial.
- Delivery window
- Delivery is tied to the site’s visit schedule, not to logistical convenience.
- Trial blinding
- Transport paperwork must not carry information that could unblind the study.
- Traceability
- Full chain of custody is documented: who, when and under what conditions, point by point.
What moves in this flow?
- Investigational medicinal product (IMP) and comparator.
- Trial kits and packaging materials to sites.
- Shipments between CDMO, CRO and depot, central or local.
- Return of unused product for reconciliation or destruction.
Which temperature range applies?
Whatever the trial protocol sets, which in practice is almost always +2/+8 °C or +15/+25 °C, and frozen where the product requires it. The difference against a commercial flow is not the range but the tolerance to deviation: in a trial, a small excursion can force units to be excluded and documented in the study file.
How is chain of custody documented?
Through the trip temperature record, the door-opening log and the signed delivery paperwork, all referring to the same shipment and archived for five years. It is the same file issued on any pharmaceutical service, but here it is reviewed in full: in a trial, the file is part of the study. See temperature records.
Frequently asked questions
Are deliveries made directly to hospital sites?
Assessed shipment by shipment. Transport is full truck load by road, so the natural destination is a depot, a CDMO, a CRO or a platform; delivery to a specific site depends on access, goods-in hours and volume, and is agreed before the service is confirmed.
Can the sponsor’s own loggers travel with the shipment?
Yes. Sponsors routinely place their own loggers in the parcel or on the pallet, and there is no objection: they coexist with the vehicle record and serve as a cross-check. What they do not do is replace it, because the vehicle record is the one that allows a reaction during the journey.
What happens if a delay puts a patient visit at risk?
It is reported as soon as it is detected, not on arrival. Fleet tracking is real-time, so a delay caused by a traffic or border incident is visible before it becomes irreversible, and that is what gives the sponsor room to reschedule or find an alternative.
Need a full truck for pharmaceutical or refrigerated freight?
Tell us origin, destination, temperature range, product type and volume. A dedicated account manager comes back with a firm quote within one working day. If it is urgent, call.