Clinical Trial Supply Management
End-to-end supply oversight that keeps every patient visit supplied and every study audit-ready.
Bensen Solutions manages clinical supply across Phase I–IV trials for small molecules, biologics, and cell & gene therapies. We own the supply chain from protocol assumptions through final reconciliation, so sponsors and study teams can focus on the science rather than firefighting stockouts.
Our work spans RTSM strategy, comparator and ancillary sourcing, depot networks, and expiry management — coordinated as a single plan rather than a set of disconnected vendors.
What this engagement includes
Supply planning & simulation
Patient-level demand modeling and Monte Carlo simulation to size production, depots, and safety stock under enrollment uncertainty.
RTSM strategy
RTSM (randomization and trial supply management) system design, resupply triggers, and buffer settings that minimize waste without risking site stockouts.
Packaging & labeling oversight
Clinical and commercial packaging design, booklet labels for multi-country studies, and CMO oversight from setup through release.
Comparator & ancillary sourcing
Sourcing of comparator drug, co-medications, and ancillary supplies, including documentation and global logistics.
Depot & distribution network
Global depot selection, import/export and customs coordination, and temperature-controlled distribution to sites.
Expiry & resupply management
Shelf-life tracking, re-labeling and expiry-extension campaigns, and resupply runs that keep product available without overage.
How we work
- 1
Assess protocol & demand
We translate the protocol, enrollment plan, and country mix into a quantified demand and risk picture.
- 2
Design the supply strategy
We define production, packaging, depot, and RTSM strategy with the buffers and contingencies the study actually needs.
- 3
Execute & monitor
We run the plan with the CMO, depots, and couriers, tracking inventory, excursions, and resupply in real time.
- 4
Optimize & close out
We tune buffers as data comes in, then handle returns, reconciliation, and destruction at study close.
What you can expect
- No patient visit missed for lack of supply
- Lower overage and drug waste through tuned buffers
- Audit-ready documentation and full chain-of-custody
- One accountable owner across CMOs, depots, and couriers
Frequently asked questions
- What does a clinical supply chain manager do?
- A clinical supply chain manager plans and runs the flow of investigational product through a trial — forecasting demand, overseeing packaging and labeling, setting RTSM resupply rules, managing depots and couriers, and ensuring every site has the right kits in date and at temperature, all under GxP compliance.
- How do you prevent drug stockouts at clinical sites?
- Stockouts are prevented with demand simulation, appropriately sized safety stock and RTSM resupply triggers, multiple depots for redundancy, and active monitoring of inventory and enrollment so resupply happens before a site runs low rather than after.
- Which trial phases and modalities do you support?
- We support Phase I through Phase IV studies across small molecules, biologics, and cell & gene therapies, including temperature-sensitive and short-shelf-life products that need cold-chain and just-in-time handling.
- What is an RTSM and why does it matter for supply?
- An RTSM is the clinical trial system that handles randomization and trial supply management, meaning it decides who gets which treatment and makes sure the right investigational product is available at the right time. It matters for supply because it helps prevent stockouts, overstocking, wastage, and dispensing errors while maintaining blinding and traceability.
- How does RTSM differ from IVRS?
- RTSM is the broader, modern term for the system that manages randomization and trial supply, while IVRS refers specifically to the older phone-based interface used to perform those tasks. In practice, RTSM focuses on the function and supply controls, and IVRS is just one delivery method that may be part of that workflow; today's RTSM platforms usually add web access, inventory tracking, resupply logic, and integration with other clinical systems.