Outsourcing Seamless CDMO solutions
With the number of registered clinical trials increasing significantly each year, it’s not surprising to learn that the clinical trials supply and logistics market is predicted to grow exponentially in the years ahead. Such growth places huge pressure on drug discovery companies, CROs and CDMOs to find supply management solutions that ensure seamless, efficient delivery of clinical trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape. PCI Pharma Services’ clinicalSMART is one such solution.
Readiness Team (SMART) is a department of experienced clinical supplies professionals who manage clinical drug supply on behalf of clients. At the time of writing, PCI’s clinicalSMART are supporting 74 clients and 214 studies globally. Designed with flexibility at its core, clinicalSMART is able to support sponsor requirements either throughout the entire study life cycle, from protocol development through to final destruction of materials, or at specific points within the process when sponsor teams require additional resources to supplement in-house supply management expertise.
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Due to its initial successes, and a growing need from clients outside the US for the kinds of services offered by clinicalSMART, the European and Asia- Pacific team was established in 2019.
How does clinicalSMART operate? The effectiveness of clinicalSMART is best described via the following real- world case study, one of many illustrating the positive impact of integration and embedded support.
PCI was performing packaging and global distribution for a client with a very aggressive clinical plan involving seven global trials, complex multi-dose carded kits and many inventory items. At a crucial stage, the client’s CSM resigned, creating a gap in support. In response, a clinicalSMART CSM was contracted to provide supply study oversight.
Clinical Trials Insight /
www.worldpharmaceuticals.net
stablished in 2016, PCI’s clinical Supply Management and
ClinicalSMART is designed with flexibility at its core. The clinicalSMART CSM’s role included:
■ responsibility for planning and creating demand and supply schedules
■ working with the project manager to allocate inventory and stabilise the packaging schedule per trial
■ working with the distribution project manager to establish planned depot shipments
■ eliminating rushed packaging and shipments
Not only did the clinicalSMART CSM’s involvement maintain the drug supply for all trials without slowing the enrolment process, but they also worked with the client to recruit their own CSMs and trained them to assume all responsibilities going forward.
When to get SMART Regardless of the level of CSM involvement contracted to the client, the critical objective remains the same: to provide a seamless, integrated clinical supply service at the level required by the client, at any stage or throughout the
study lifecycle, while leveraging PCI’s extensive experience in this area of expertise. However, to gain maximum benefit from clinicalSMART it is recommended that services are contracted as early as possible, preferably prior to study commencement. This enables the PCI CSM to collate and analyse key information from external study stake holders and to review the protocol, the drug stability, the availability of comparators in the marketplace, the countries
involved in the study, the labelling and distribution strategy and recruitment projections.
This comprehensive assessment will help the CSM identify the least wasteful kit design and create an initial packaging forecast, which can be modified as changes arise. The CSM will also ensure the forecast is ‘fit for purpose’ by assessing it against the potential drug utilisation in the IRT.
The future of SMART
Since its conception, clinicalSMART has grown exponentially with the number of trials supported globally increasing year on year. PCI is committed to an ongoing recruitment plan to help facilitate this growth in the years to come. PCI is proud to have clinicalSMART as part of its service offering, and its continued excellence in providing seamless, integrated services aligns perfectly with the wider organisation’s goal of providing true end-to-end CDMO services for clients around the globe. ●
www.pci.com 27
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