Sharp mitigates clinical supply overproduction with IRT investment
Sharp Clinical Services’ interactive response technology (IRT) solution is used to manage patient interactions and drug supplies during clinical trials to support pharma and biotech clients from Phase I trials through to commercialization.
The IRT solution also supports and performs functions for drug depots and investigative sites.
A Sharp spokesperson told us, “Having recently completed the expansion and fit-out of our clinical facilities in Bethlehem, Pennsylvania, and Rhymney UK, Sharp is now investing in the core clinical services we offer our clients. We believe Clinical IRT offers tremendous potential to improve trial management and efficiencies, and this investment reflects that belief.”
The spokesperson further explained that the IRT service is designed to use captured data with protocol design to produce ‘actionable’ information. This can then be used to determine the amount of clinical supplies needed to produce, how much is needed for initial shipments, and how much will be required to re-supply sites for the duration of the study.
Enhancements to the IRT solution will see the addition of a supply forecaster which will predict patient enrollment and clinical supply consumption, as well as a warehouse return system to ensure accountability for returns from clinical sites. Additionally, integration with the company’s enterprise resource planning (ERP) system will streamline work across its internal divisions and customers, according to Sharp.
The introduction of dynamic randomization with minimization and simulation to the IRT also will help determine the impact of randomization on the treatment type and enable sufficient clinical supply allocations to the clinical study.
"Supplying a clinical trial requires a sponsor to produce more than the 100% of the supplies which will be used. In a typical trial up to 200% is produced, sometimes even more,” the spokesperson said.
Clinical supplies are usually expensive and in short supply, and the use of IRT can help reduce the overproduction of supplies needed for clinical trials while ensuring that the supply is there at the time it is needed. The spokesperson explained that if the supply is not where it’s needed the potential loss of a patient to the clinical trial is quite possible.
Recent investments and expansions
Sharp recently completed expansions at its clinical facilities as well. Earlier this month, the company invested $9m at its Bethlehem, PA-based site after purchasing the facility for $14m. The investment saw the refitting of the facility and relocation of services from its previous Phoenixville site.
Frank Lis, president of Sharp said that the facility is now home to clinical services and clinical manufacturing which “dramatically reduces the risks, costs and supply chain complexity for our clients.”
Sharp has also made investments in its UK operations for the same purpose; reducing risk and mitigating supply chain complexity. The company invested $11.3m in a facility in Rhymney, South Wales for clinical packaging.