International pharmaceutical outsourcing services provider PCI Clinical Services (PCI) completed its dedicated Returns Management facility at its Clinical Services Center of Excellence at Bridgend, UK.
PCI provides 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 with efficiency and precision.
The new, custom-fit facility enhances PCI’s expansive clinical storage and distribution presence in Bridgend. The development reinforces the organization’s ongoing investment in and expansion of its global clinical services network. This reflects the company’s long-term commitment to ensuring successful clinical study outcomes for its clients and enables successful commercialization of drug products and speed-to-market for potentially life-saving treatments.
PCI is a full-service provider of outsourced pharmaceutical services for the global healthcare industry, including drug development and both clinical and commercial scale manufacture; clinical trial supply for investigational medicines, including storage and worldwide distribution; as well as contract packaging services for commercial medicines.
Bridgend is one of PCI’s eight global facilities supporting medicines distributed to more than 100 countries worldwide.
PCI’s Kevin Williams, Clinical Site Leader for the Bridgend facility, says, “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 ensure compliancy and best practice, as well as to mitigate costs, ultimately supporting successful commercialization 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.”