Case Study

Hybrid Sourcing & Just-In-Time Labeling in Global Clinical Trials

Faced with a multi-country Phase III trial using costly rescue medication, Myonex implements a hybrid sourcing strategy with Just-In-Time Labeling and local sourcing via CTRx^®. This approach ensures speed, flexibility, and uninterrupted supply across 17 countries.

Client: Global Pharma Company
Study: Phase III, 3-arm trial in endocrine disease
Participants: 105
Duration: 40 months (expected)
Countries: 17
Products: Commercial drugs used as rescue medication

Challenge

Managing a 17-country Phase III trial requires a sourcing strategy that could balance regulatory compliance, cost efficiency, and flexibility.

The study involves expensive commercial rescue medication and sites with unpredictable enrollment rates and drug requirements. While centralized sourcing offers consistency, it also risks overstocking or delays. Local sourcing can provide speed but varies in feasibility depending on market conditions, product availability and local regulatory requirements.

The sponsor required an approach that balances speed and compliance while addressing multi-language labeling needs across global sites.

The Myonex Solution

In this context, Myonex strategy designs and executes a hybrid sourcing and labeling strategy, tailored to each country’s regulatory constraints and study dynamics.

Central Sourcing with Just-In-Time Labeling (12 EU countries)

Through centralized sourcing, Myonex in Le Haillan, France, secures drug availability across Europe while maintaining full control of the supply chain.

In this multi-language trial, to avoid allocating drug stock to a specific country, and since the data to be printed allowed it, Just-In-Time labeling (JIT) with one simple label per country replaces traditional booklet labeling. Labels are printed in-house, at Myonex Le Haillan facility, and labeling is performed immediately prior to shipment via application of the corresponding country label.

Additionally, this solution eliminates the need for reprints or new booklet versions if an additional language or a minor, non-critical data change in the label text is required during the study.

Our JIT labeling approach also provides backup flexibility: if local sourcing in one of the other EU study countries (ie. Spain or France) becomes unavailable, central sourcing with JIT labeling could immediately take over with the stock available at Myonex Le Haillan, preventing shipment interruptions.

CTRx Local Sourcing for Targeted Markets (5 global countries)

For Spain, France, UK, Brazil, and Israel, Myonex coordinates local sourcing adapted to each market’s regulatory and logistical context:

Spain, France, UK, Brazil: local sourcing without labeling enables the pre-purchase of small drug quantities regularly throughout the study, which allows flexibility in quantities purchased and reduces waste.

Israel: local sourcing with clinical labeling ensures full compliance with national regulations without the need for importation of labeled products from a central depot.

This local sourcing model gives flexibility, avoids waste, and provides very short turnaround times from shipment request to delivery at site.

Seamless Operations Across Regions

For centrally sourced countries, Myonex’s French team has preloaded shipment data into the IRT to streamline future requests. When a shipment request is received, Myonex Le Haillan prepares the order and applies the label of the corresponding country immediately before dispatch, without needing to pre-assign stock to any specific country. A QA release is then performed to authorize distribution of the labeled commercial drug.

For locally sourced regions, Myonex’s CTRx® solution is implemented. The myCTcentral® portal enables sites to place orders directly after receiving portal training, offering a fast and convenient process with real-time visibility.
When ordering using the myCTcentral portal, sites place their orders only once it is determined that a patient needs the rescue medication; further reducing waste and offering flexibility of supply.

This operational flexibility allows the sponsor to respond quickly to enrollment fluctuations and avoid supply interruptions.

Results

Flexibility: Hybrid sourcing combines the strengths of local and central models, adapting to availability and regulatory constraints across 17 countries. Additionally, JIT labeling makes it possible to use a single batch for multiple countries, without any prior allocation.
Speed: In-house JIT labeling reduces labeling setup lead times compared to the standard multi-language booklet approach. Our CTRx model ensures that local partners can fulfil shipment requests in-country with a very short turnaround time.

Cost Efficiency and Waste Reduction: Minimizing overstock of expensive products via both Myonex’s CTRx solution (local sourcing) and a central batch labeled Just-In-Time, just before distribution, optimizes the sponsor’s trial budget.
Continuity: The study progresses without supply gaps, despite variable recruitment rates and labeling requirements.

Nurse wearing mask next to patient in hospital bed. Patient is an older woman

Conclusion

By combining hybrid drug sourcing with Just-In-Time labeling, Myonex delivers a solution that unites global control with local agility.

This project demonstrates how Myonex’s integrated clinical supply capabilities, spanning sourcing, labeling and logistics, empower sponsors to navigate global studies while maintaining speed, flexibility and cost efficiency.

Reliability, compliant, and on-time delivery of critical rescue medication to patients across 17 countries are achieved with Myonex’s integrated strategy

FAQ

Q1. What is hybrid drug sourcing in clinical trials?
Hybrid sourcing combines centralized drug supply with targeted local sourcing to balance consistency, speed, and regulatory compliance across multiple countries.

Q2. Is the hybrid sourcing model compliant with country-specific regulations?
Yes. Each sourcing pathway is tailored to local regulatory requirements, with QA oversight at every step.