PCI provides a full service Returns Management service for our 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 our expansive Clinical Storage and Distribution presence in Bridgend.
The development reinforces the organization’s ongoing investment in and expansion of our global Clinical Services network, reflecting our long-term commitment to ensuring successful Clinical study outcomes for clients; enabling successful commercialization of drug products and ultimately 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 which are distributed to over 100 countries worldwide.
This latest addition to the Center of Excellence provides a modern, high-spec unit, purpose-built to process Return Drugs from Clinical Trials in a dedicated facility. It complements the existing facilities at Bridgend, which are currently used for specialist Clinical Trial Logistics as well as Packaging, Labeling and Qualified Person activities for Investigational Medicinal Products.
PCI Clinical Services Bridgend facility clinical site leader Kevin Williams said: “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.”
The 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.
Source: Company Press Release