An Italian biotech company was preparing an ambitious Phase III interventional study involving 170 patients across 15 clinical sites in 7 countries. The protocol presented a unique operational challenge.
Patients had to self-administer therapy using 2-litre solution bags up to three times daily for 180 consecutive days. Each participant needed a continuous supply of a large-volume investigational medicinal product (IMP) throughout the study.
When investigational product logistics become as critical as clinical data
Providing the entire treatment supply at the start was not feasible. Patients would have had to store large quantities of product at home, creating practical and logistical difficulties.
To address this challenge, the study incorporated a structured replenishment model to ensure patients received regular IMP deliveries throughout the trial. While this approach improved patient experience and aligned with standard clinical practice, it introduced a new level of complexity for the sponsor.
How can a study team ensure uninterrupted treatment across seven countries while maintaining full traceability of every shipment, every dose calculation, and every inventory movement?
This question lies at the heart of modern IMP management home-shipment strategies.
The challenge: managing high-volume IMP supply across multiple countries
For many clinical trials, investigational product management is largely site-based.
This study was different.
Each patient required substantial volumes of treatment over six months. Replenishment deliveries had to be coordinated continuously while ensuring product availability at local repositories and clinical sites.
Without a centralized system, sponsors face risks like inventory shortages at local repositories, delayed deliveries, treatment interruptions, increased site workload, limited visibility, and complex reconciliation:
- delayed replenishment deliveries.
- Treatment interruptions.
- Increased operational workload for sites.
- Limited visibility across countries.
- Complex reconciliation activities.
As decentralized and hybrid clinical trial models continue to expand, these challenges are becoming increasingly common.
Guidance from regulatory bodies such as the European Medicines Agency (EMA) recognizes the growing importance of decentralized trial components, including direct-to-patient logistics and remote participation models.
Why traditional systems struggle with home shipment models
Many organizations still manage drug supply, patient data, and shipment activities through separate platforms.
A typical workflow may involve a Randomization and Trial Supply Management (RTSM) or Interactive Response Technology (IRT) system:
- Local repository management tools.
- Courier tracking systems.
- Electronic data capture platforms.
- Patient reporting applications.
When these systems operate independently, teams spend significant time reconciling information.
A shipment may be delivered, yet clinical teams may not immediately know if the patient received, stored, and administered the treatment as prescribed. This creates data silos that increase monitoring effort and complicate regulatory inspections.
The challenge is not simply moving an investigational product from one location to another, and maintaining a continuous and auditable connection between logistics and clinical data.
A smart RTSM approach to IMP management and home shipment
To support this study, Nubilaria implemented its smart Randomization and Trial Supply Management (RTSM) platform as the operational backbone for investigational product management.
Unlike traditional supply systems that focus primarily on randomisation and treatment allocation, the platform was designed to support the entire supply chain. The solution enabled the sponsor to:
- track and calculate patient-specific dose requirements.
- Manage local IMP repositories across multiple countries.
- Monitor inventory levels in real time.
- Coordinate replenishment activities.
- Support home shipment logistics.
- Maintain complete treatment traceability.
By centralizing these activities in single validated environment, study teams gained visibility across all countries without increasing operational burden.
A modern clinical trial supply management solution, such as ACTide Randomisation and Trial Supply Management (RTSM), can help sponsors automate forecasting, inventory management, dose calculations, and replenishment workflows while supporting increasingly complex decentralized trial models.
Learn more about ACTide RTSM and see how advanced supply management simplifies multinational studies.
Connecting logistics with clinical data
Efficient logistics alone do not guarantee study success.
Sponsors must also understand whether patients are receiving and using treatment as intended. This is where integration becomes essential.
Using ACTide electronic Case Report Form (eCRF), shipment information can be linked directly to patient records, allowing Data Managers and monitors to verify treatment availability alongside clinical data.
Instead of manually reconciling data from multiple systems, study teams access a single source of truth. Benefits include:
- faster monitoring activities.
- Improved data quality.
- Reduced reconciliation workload.
- Enhanced inspection readiness.
From shipment confirmation to treatment compliance
In this study, patients self-administered treatment up to three times daily for six months.
Tracking deliveries was only part of the process.
The sponsor also needed visibility into actual treatment adherence.
Through ACTide electronic Patient Reported Outcome (ePRO), patients can confirm treatment administration directly from their smartphones, creating a direct link between IMP delivery, patient-reported information, and compliance monitoring.
This approach transforms home shipment from a logistical process into a fully connected patient-centric workflow. As decentralized clinical trials evolve, integrating supply management and patient engagement technologies is essential for compliance and data quality.
How integrated ecosystems are redefining IMP management
The future of IMP management home shipment is not simply faster delivery. It is digital integration.
The ability to integrate dose calculations, inventory forecasting, local repositories, home shipment, clinical data capture, and patient compliance into a single ecosystem enables Sponsors and CROs to manage increasingly complex studies with greater confidence. For multinational Phase III studies, maintaining uninterrupted treatment while preserving data integrity requires more than logistics expertise.
It requires a connected platform that supports every step of the patient journey.
Planning a complex global study with home shipment requirements? Discover how the ACTide ecosystem combines RTSM, eCRF and ePRO capabilities to simplify IMP management, improve compliance, and maintain full operational visibility.