In many areas of clinical research, central pharmacies have become, pun intended, ‘central’ to the implementation of clinical trials. Many sites do not have the infrastructure necessary to properly store increasingly delicate investigational product (IP). Depots in countries with stricter import regulations may also necessitate the use of central pharmacies within a region to avoid shipment delays. With trials becoming more decentralized, central pharmacies are an increasingly essential infrastructural component of the clinical supply chain.
IRT has evolved to address these added levels of complexity to make clinical supply management more efficient and flexible for clinical teams. Suvoda’s current functionality helps clinical teams to manage inventory at central pharmacies and satellite sites to give them much needed flexibility in their supply chain strategy.
How IRT Helps Manage Central Pharmacy
To understand how central pharmacy functionality is implemented within IRT, we have to understand how central pharmacies fit into the overall ecosystem. Suvoda IRT system has functionality that can designate sites into three types:
- Regular sites that get their IP directly from distribution depots.
- Central pharmacy sites that route IP supply from depot to satellite sites.
- Satellite sites that receive their IP via central pharmacies.
Satellite sites get their drug supply dispensed directly from the central pharmacy because they do not have the infrastructure capable of housing IP inventory. Strict guidelines such as those provided by USOR (US Oncology Research) may also necessitate the use of satellite sites. As far as the IRT is concerned, all inventory for each satellite site is managed and dispensed by its corresponding central pharmacy to the satellite.
While satellite sites do not actively dispense or order the drug within the IRT, they are still capable of setting unique resupply strategies to define how much drug they will need within an interval of time. Satellite sites are also capable of managing accountability for drug units that are assigned within the IRT. The central pharmacy inventory is resupplied to a level appropriate for all of its linked satellite sites, with the ability to account for extra supply. With this functionality in place, locations can allocate supplies more efficiently so that central pharmacies can maintain stock for expected and unexpected needs.
Central pharmacies have the added challenge of figuring out how to deliver drug to sites. In the case of direct-to-patient shipments, however, satellite sites can opt for central pharmacies to send drug directly to patients' homes. This reduces complexity in the supply chain by eliminating an unnecessary leg in getting medication into the patients’ hands.
Many IRT vendors have found central pharmacy functionality difficult to implement. When IRT has other customizations related to drug ordering, dispensation, and inventory management, for instance, this can create additional complexity that must be properly managed by both the vendor and sponsor vendor teams.
Suvoda has collaborated with sponsors to create the kind of flexibility that central pharmacies and satellite sites need. So far, we’ve powered approximately 75 studies with central pharmacy functionality as a versatile solution to this critical complexity in the clinical supply chain. With our dynamic systems, study teams can keep up with intricate trial logistics, adhere to rigorous requirements, and focus on creating dynamic, efficient clinical supply strategies.