Continued investment at Bridgend site enables capacity expansion for segregated space in support of the return of investigational drug products used in clinical studies
Leading international pharmaceutical outsourcing services provider PCI Clinical Services (PCI) has announced the completion of a dedicated returns management facility at its Clinical Services Center of Excellence at Bridgend, UK.
PCI offers a full service returns management service for clients, providing visibility and accountability in returning investigational drug product from investigational sites at the conclusion of a clinical study.
Returning and reconciling Investigational Medicinal Product (IMP) on completion of a study is a critical part of a clinical trial and can require complex reverse logistics. Trial outcomes can be impacted if returns are not processed efficiently and precisely.
The new, custom fit facility enhances PCI’s expansive clinical storage and distribution presence in Bridgend. The development reinforces the organisation’s ongoing investment in and expansion of its global clinical services network, reflecting PCI’s long-term commitment to ensuring successful clinical study outcomes for its clients — enabling the successful commercialisation of drug products and expediting speed-to-market for potentially life-saving treatments.
PCI’s Kevin Williams, Clinical Site Leader for the Bridgend facility, commented: “The returns process can involve thousands of product packages from investigational sites around the world. Each of these must be stringently accounted for, sometimes down to individual dose level. Any discrepancies can tie up valuable time and resources, potentially inhibiting the formal close of the study and progression of the drug in its development.”
“Having a dedicated space to store and process return drug product is a clear demonstration of PCI’s commitment to the continued investment in our clinical offerings for the benefit of our clients in navigating the various phases of investigational study."
"Thorough consideration of returns in the early stages of a study helps to ensure compliancy and best practice, as well as to mitigate costs, ultimately supporting successful commercialisation and effective delivery to market of our clients’ products. We help advise clients both at the initial development of the study as well as facilitate the study closure, to ensure a thorough and seamless process, regardless of where in the world their studies are being executed.”
PCI’s new returns management facility follows other recent investments at the Bridgend location. PCI announced a site expansion with a new 37,500 square foot building, which opened in January 2018, expanding its clinical trial services campus in Bridgend.
PCI also announced geographic expansions through acquisitions, adding presence and new capabilities for early phases sterile and non-sterile drug manufacture in Melbourne, Australia, in February 2018 through the purchase of Pharmaceutical Packaging Professionals (PPP), as well as a new EU-based location in Dublin, Ireland, in October 2017 through the purchase of Millmount Healthcare.
PCI also recently announced the acquisition of Sherpa Clinical Packaging, located in San Diego, California, furthering its strategy to support clients with responsive services in key geographies around the world.