Clinical Trial Supply · Europe

The supply function you need. Not the headcount you can't justify.

Most small and mid-sized sponsors face the same problem. Clinical supply is critical, but it doesn't justify a full-time senior hire — and large service providers won't sell below a full engagement. The result is a gap covered by someone already stretched across three other roles.

Change · Your · Vision · Angle

Senior IMP supply management, under a vendor contract rather than a headcount.

IMP demand forecasting and drug-pool management
Supply strategy per protocol, including buffer and resupply logic
IRT/RTSM specification input and UAT oversight
CMO/CDMO and depot vendor oversight
Comparator and ancillary sourcing strategy
Labelling strategy and Annex 13 compliance
Import/export and QP release coordination
Temperature excursion management and deviation escalation
Depot network design and distribution routing
ICH E6(R3) and GxP alignment across the supply function
Out of scope: QP certification itself, regulatory submissions, GMP manufacturing, and acting as legal sponsor representative.

Fifteen years, delivered not described.

Sponsor-side clinical supply management across cold-chain biologics programmes, from first-in-human studies to global pivotal trials exceeding 10,000 patients.

20
Studies owned
End-to-end supply responsibility, Phase I through Phase III
5
Global depots
Central and regional networks across four continents
4
IRT platforms
Vendor-agnostic across the major systems in use today
15
Years
UCB · Janssen · Baxter · Thermo Fisher · CEVA Logistics / J&J

Programme complexity handled

Cold-chain biologics across IV, subcutaneous, lyophilised and prefilled-syringe presentations
Active-comparator programmes — sourcing, blinding, and expiry management
Direct-to-patient distribution alongside conventional site supply
Multi-country depot networks with regional resupply and buffer strategy
Import, export and QP release coordination across EU, UK, Switzerland, US, Latin America, Japan, China and Ukraine
IRT/RTSM specification, UAT and in-study parameter management across 4G Clinical, Endpoint Clinical and Calyx
Demand forecasting and simulation using N-SIDE optimisation tools
CMO/CDMO, packaging and depot vendor oversight across Almac, Fisher Clinical Services and DHL networks
Sponsor-side supply ownership on CRO-run programmes, including Parexel and IQVIA
Temperature excursion management, deviation escalation, and Annex 13 labelling compliance

Figures aggregate roles held across commercial pharmaceutical supply chain and clinical trial supply management. Sponsor and programme names withheld under confidentiality.

Three ways to bring the function in.

Engagement 01

Advisory Retainer

Standing senior access without execution ownership. Monthly supply risk review, protocol and amendment review from a supply-feasibility standpoint, vendor selection input, and on-call escalation support.

Engagement 02

Fractional Supply Lead

A named senior lead owning clinical supply strategy and execution oversight across a defined set of studies. Typically two to three days a week over six to twelve months.

Engagement 03

Interim Cover

Full functional coverage during a vacancy, a CDMO transition, or a programme scale-up. Including handover to the permanent hire when they arrive.

Ten days in, you know exactly what you've bought.

Every engagement opens with a written Supply Risk Baseline — every open supply risk across your studies, scored, with immediate actions flagged. Delivered by day ten.

It is also available as a standalone piece of work, independent of any longer engagement — and it gives whoever you eventually hire a proper starting point.

Deliverable · Day 10
Every open supply risk across your studies, scored, with immediate actions flagged.

A company, not a freelancer.

Named deputy
Every engagement carries a named backup and current handover documentation
Filed accounts
Profitable every year since 2021
Insured
Professional indemnity in place, certificate on request
Vendor-ready
Quality agreement, SOPs and GxP questionnaire responses available
Coverage
EU, UK and Nordic supply operations — for sponsors based anywhere

Ready to change your vision angle on supply capacity?

Tell us what your programme looks like and where the gap sits. We will come back with the engagement model that fits — and what the first ten days would cover.

Révérien Uwacu
Founder & CEO
info@reve-solutions.com +32 479 12 68 74 LinkedIn →
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