Clinical trial laboratory with investigational medicinal products

Phase I – IV

Clinical Trial Logistics

Cold chain logistics for clinical trials across Europe: temperature-controlled IMP distribution to investigator sites, GDP-compliant and audit-ready. Clinical trial logistics services covering Phase I to Phase IV logistics with seamless cloud tracking.

+49 6172 3950679

Phase I to Phase IV logistics – clinical study logistics end to end

From first-in-human to post-marketing – tailored clinical trials shipping solutions for every stage of your programme.

Phase I

First-in-Human

Small volumes, highest safety requirements. Often single shipments to specialised sites under tight deadlines.

Phase II

Proof of Concept

Increasing complexity with multiple sites. Coordinated distribution under strict temperature requirements.

Phase III

Pivotal Studies

Large-scale distribution to dozens of investigator sites across DACH and Europe. Just-in-time delivery and returns.

Phase IV

Post-Marketing

Ongoing supply to investigator sites, comparator sourcing and returns management.

Risk awareness

Risks of inadequate trial logistics

Every weak link in the supply chain puts your clinical trial at risk. That is why sponsors and CROs rely on specialised partners.

Patient delay

If investigational medicinal products do not arrive on time, treatments are delayed. Every day counts.

Data integrity

Temperature excursions without documentation jeopardise study results and the entire approval process.

Regulatory consequences

FDA and EMA audits are getting tougher. Non-compliant logistics can put the whole study at risk.

Cost explosion

Failed deliveries mean new batches, new randomisation, new timelines. Costs multiply.

Cold chain logistics for clinical trials with live tracking

Track the transport of your investigational medicinal products in real time – from depot pick-up to delivery at the investigator site.

Startpunkt

Zielpunkt

Live-Position

Why sponsors and CROs choose TempSecure

Clinical trial logistics demand more than a standard courier. See for yourself.

Merkmal	TempSecure	Typischer Wettbewerb
Ansprechpartner	1 fester Kontakt, 24/7	Wechselnde Hotline
Reaktionszeit	10–30 Minuten	Stunden bis Tage
Angebot Landtransport	Innerhalb 1 Stunde	Tage
Temperaturmonitoring	Live Cloud-Tracking (Tive), inklusive	Analoger Bon, oft Aufpreis
Proaktivität	Feiertage, Route, Dokumente vorab geprüft	Reaktiv nach Problem
Krisenmanagement	Sofort-Alarm, Ersatzfahrzeug, Root Cause Analysis	Kunde muss nachfragen
Zertifizierung	GDP + ISO 9001	Oft nur Standard

Your benefits with TempSecure

Six reasons why pharma companies and CROs trust us as their logistics partner for clinical trials.

Audit-qualified

Our processes are fully documented and GDP-compliant. We pass audits by sponsors, CROs and regulators.

Strict timelines

Clinical trials do not tolerate delays. We guarantee vehicle availability within 2 hours and response times under 30 minutes.

Seamless temperature records

Tive cloud tracking delivers GPS and temperature data every 5 minutes. Full audit trails for your study file.

CRO partnerships

We act as an extended logistics arm for CROs and CTS providers. Dedicated point of contact and project management.

All temperature ranges

From +15 to +25 °C and +2 to +8 °C through to -60 to -80 °C (dry ice) and cryogenic transports down to -196 °C.

Packaging expertise

va-Q-tec and Intelsius thermoboxes with PCM packs for up to 120 hours of hold time. Cryoshippers for cell and gene therapies.

Temperature ranges for clinical trials

Lückenlose Kühlkette über das gesamte Temperaturspektrum – validiert, dokumentiert und GDP-konform.

-196°C-80°C0°C+25°C

-150 bis -196°C

Liquid Nitrogen

Stammzellen, Flüssigstickstoff, GMOs

-60 bis -80°C

Dry Ice

Biotech, Zelltherapien, klinische Studien

-15 bis -25°C

Frozen

APIs, Wirkstoffe, Chemikalien

+2 bis +8°C

Cold / Cool

Blutprodukte, Impfstoffe, Biopharma

+15 bis +25°C

Ambient / CRT

Medikamente, Chemie, Standard-Pharma

From depot to investigator site – step by step

Every study transport follows a clear, audit-ready process.

SCHRITT 011-2 business days

Study onboarding

Joint definition of SOPs, temperature requirements, route planning and escalation processes for your study.

SCHRITT 02as scheduled

Depot pick-up

GDP-compliant pick-up of the IMPs at the sponsor, CTS depot or central warehouse with qualified packaging.

SCHRITT 03< 2 hrs

Temperature conditioning

Pre-conditioning of thermoboxes, addition of data loggers and dry ice. Final quality control before departure.

SCHRITT 04real time

Direct transport

Dedicated vehicle transport without transshipment. Cloud tracking delivers GPS and temperature data every 5 minutes.

SCHRITT 05as scheduled

Site delivery

Handover to trained personnel at the investigator site. Documented hand-off with signature and temperature record.

SCHRITT 06< 24 hrs

Documentation & reporting

Full audit trail with temperature history, GPS route and proof of delivery. Ready for sponsor audits.

Scientist in the laboratory during a clinical trial

CRO partnership

Your extended logistics arm

As a specialised logistics partner for CROs and CTS providers, we handle the temperature-controlled distribution of your investigational medicinal products. From sponsor pick-up to site delivery – with full transparency and GDP compliance.

Dedicated project manager for every study
Tailored SOPs to your specifications
Regular performance reports and KPI dashboards
24/7 emergency hotline for time-critical situations
Experience with comparator sourcing and returns logistics
Seamless integration into existing study processes

Certified quality for clinical trials

ISO 9001

Zertifiziertes Qualitätsmanagementsystem für konsistente Prozessqualität in jeder Sendung.

GDP

Good Distribution Practice – der Goldstandard für den Transport pharmazeutischer Produkte.

ADR

Europäisches Übereinkommen für den Transport gefährlicher Güter auf der Straße.

„Unsere Zertifizierungen sind nicht nur Dokumente – sie sind unser täglicher Anspruch an jeden einzelnen Transport.“
– Lennart Kuhn, Gründer TempSecure

Lückenlose Temperaturprotokolle

Regelmäßige Fahrerqualifikation

Dokumentierte Standardprozesse

Kontinuierliche Verbesserung (KVP)

Frequently asked questions on trial logistics

Which investigational medicinal products (IMP) do you transport?

We transport all common IMPs: biologics, small molecules, mRNA-based drugs, cell and gene therapies as well as comparator products. Our temperature range covers +25 °C down to -196 °C (cryogenic). Qualified packaging solutions are available for every product category.

How do you ensure audit readiness?

Every transport is documented end-to-end: GPS route, temperature history in 5-minute intervals, hand-off records and chain-of-custody evidence. All data is available as a digital audit trail and can be integrated directly into your study file. Our processes are GDP-compliant and regularly reviewed in sponsor audits.

Which trial phases do you cover?

We support clinical trials from Phase I (first-in-human) to Phase IV (post-marketing). In Phase I and II these are often single, highly sensitive shipments. From Phase III onwards we take over coordinated distribution to dozens of investigator sites across Europe. In Phase IV we ensure ongoing supply.

How does collaboration with CROs work?

We act as the extended logistics arm of your CRO. That includes a dedicated project manager, study-specific SOPs, regular performance reports and a 24/7 emergency hotline. We integrate seamlessly into existing study workflows and communicate proactively in case of deviations.

How do you monitor temperature during transport?

We use Tive cloud trackers that transmit temperature and GPS data every 5 minutes. You receive a personal tracking link with live insight. Deviations trigger automatic alerts and our dispatch team responds immediately. Calibrated data loggers are also included.

Can you handle depot-to-site transports across Europe?

Yes, we run depot-to-site transports in over 30 European countries. From pick-up at the sponsor or CTS depot to delivery at the investigator site – as a direct transport without transshipment. For sites outside Europe we coordinate air freight with GDP-qualified partners.

What happens during a temperature excursion in transit?

Our system detects deviations in real time. An escalation protocol is triggered immediately: the driver is contacted, the customer is informed and immediate measures are taken (e.g. refilling dry ice). All deviations are documented end-to-end so that your study lead can make an informed decision.

How quickly can you provide a transport for a clinical trial?

For scheduled study transports we coordinate the time windows in advance. For ad-hoc requests we provide a qualified vehicle within 2 hours. Our response time to enquiries is under 30 minutes – including weekends and public holidays via our 24/7 emergency hotline.

Your contacts for trial logistics

Personal support from logistics experts with experience in clinical research.

Lennart Kuhn

Gründer & Geschäftsführer

Erfahrung: 4 Jahre Pharmaindustrie

Fokus: Speziallogistik / Luftfracht / klinische Studien

+49 172 7949678 [email protected]

Maurice Wendler

Operative Leitung

Erfahrung: 25+ Jahre Logistik

Fokus: Landtransporte / Projektlogistik / Krisenmanagement

+49 6172 3950679 [email protected]

How we support your study

From the first conversation to the final transport – a structured process for maximum safety and efficiency.

Kick-off & study understanding

We analyse your study protocol, identify logistical requirements and create a tailored transport plan.

SOP development

Together with your team we create study-specific Standard Operating Procedures for every transport step.

Packaging qualification

Selection and qualification of thermoboxes for your specific temperature requirements. Documentation in line with GDP Annex 15.

Route planning & time slots

Route optimisation considering investigator site opening hours, public holidays and customs requirements.

Ongoing distribution

Regular supply to your investigator sites with real-time tracking, proactive communication and immediate escalation on deviations.

Monitoring & reporting

Monthly performance reports, KPI dashboards and continuous process optimisation throughout the study.

Discuss your trial logistics

Are you planning a clinical trial or looking for a reliable logistics partner? Contact us for a no-obligation initial conversation.

Call us directly