Case Study

Hybrid Sourcing & Just-In-Time Labeling in Global Clinical Trials: The Debiopharm Case

Client: Debiopharm, a global pharma company
Study: Debio 4126-301, a Phase III, randomized 3-arm trial in growth hormone disorders
Participants: 119
Duration: 48 months (expected)
Sites/Countries: 70 investigational sites in 20 countries
Products: Commercial drugs used as rescue medication

Challenge

Managing a 20-country Phase III trial requires a sourcing strategy that balances regulatory compliance, cost efficiency, and flexibility.

The Debiopharm-sponsored 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.

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

The Myonex Solution

To support Debiopharm, Myonex has designed and is executing a hybrid local and central sourcing and labeling strategy, tailored to each country’s regulatory requirements and study dynamics. This approach is expected to deliver up to 65% cost saving, compared with using a traditional central sourcing model.

Central Sourcing with Just-In-Time Labeling (14 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 allows for it, a Just-In-Time labeling (JIT) solution was proposed. A single simple label is applied in the language that is required for the specific country prior to shipment, which replaces the traditional booklet labeling. Labels are printed in-house, at one of Myonex’s EU-based facilities, and labeling is performed immediately prior to shipment.

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 be provided with the stock available at the Myonex depot, preventing shipment interruptions and ensuring that patients are able to receive timely treatment.

Myonex CTRx^® Local Sourcing for Targeted Markets (6 global countries)

For several countries in Debiopharm’s study, namely Spain, France, UK, Brazil, Israel and USA, 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 the drug expiry and quantities purchased, and reduces waste.
Israel: Local sourcing with clinical trial labeling ensures full compliance with national regulations without the need for importation of labeled products from a central depot, resulting in a shortened lead time for the product to be available for shipment to sites
USA: Sourcing from a Myonex-qualified Pharmacy Partner – the site staff complete a prescription order form that is sent to the Pharmacy Partner and the drug is shipped overnight in commercial packaging with a patient-specific label attached. This reduces waste and the need for sites to store expensive drug on-site.

This CTRx local sourcing model is expected to provide flexibility, minimize waste, and enables very short turnaround times from shipment request to delivery at site.

Seamless Operations Across Regions

For centrally sourced countries, Myonex’s EU team has preloaded shipment data into the IRT to streamline future requests. When a shipment request is received, Myonex 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 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 after it is determined that a patient needs the rescue medication, further reducing waste and offering flexibility of supply.
For CTRx North America sites, site staff uses the myCTcentral portal to instantly generate a CTRx Pharmacy Card for each patient (USA only). The information on the CTRx Pharmacy Card is included in the Prescription Order Form that is sent to the Myonex-qualified Pharmacy Partner for instant payment of the study medications with no costs to the sites or patients. The Prescription Order Form and all other resource materials are created and supplied by Myonex.

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

“By implementing a hybrid sourcing strategy, Myonex aims to maintain flexibility across regions, help significantly control costs, and reduce waste. Most importantly, our primary objective is to ensure sites have access to rescue medication when it is needed.”
– Ana-Zeralda Canals Hamann, Associate Director, Clinical Trial Supply
Debiopharm

Results

Flexibility: For Debiopharm, the hybrid sourcing model is expected to combine the strengths of local and central supply approaches, enabling adaptation to availability and regulatory constraints across 20 countries. 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. The Myonex’s CTRx model is designed to enable local partners to fulfil shipment requests with very short turnaround times.

Cost Efficiency and Waste Reduction: By minimizing overstock of expensive products through both Myonex’s CTRx solution (local sourcing) and a central batch labeled Just In Time, the model is expected to optimize Debiopharm’s trial budget and reduce waste. It is projected that this approach could deliver cost savings of up to two thirds, compared to a traditional central sourcing model.

Continuity: The strategy is designed to mitigate the risk of supply interruptions, supporting continuity, despite variable recruitment rates and evolving 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 aims to deliver a solution that unites global control with local agility.

This ongoing collaboration with Debiopharm is expected to demonstrate once again how Myonex’s integrated clinical supply capabilities can support global studies, helping Debiopharm maintain speed, flexibility and cost efficiency. The model is designed to support reliable, compliant, and timely delivery of critical rescue medication to patients across all participating countries.

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.