Parexel makes strategic moves in EU, South America
The hub expands Parexel’s capacity to provide clinical trial supply and logistics services to support clients’ local, regional and global trial requirements. Capabilities include synchronized coordination of clinical trial supplies, ancillary supplies and central laboratory services.
Spokeswoman Cristi Barnett told Outsourcing-Pharma.com that the facility in Germany features more than 65,000 cubic meters of storage space, offers lab-kit assembly, and storage and distribution of ancillary materials. In addition, it will be licensed to store Investigational Medicinal Products (IMPs) and Non-Investigational Medicinal Products (N-IMPs).
It will also offer secondary packaging, re-labeling, and compliance with Good Distribution Practice (GDP) of medical devices and ambient, refrigerated and frozen medicinal products, including controlled substances. On-site Qualified Person (QP), Quality Control (QC) and production personnel will manage regulatory-compliance requirements. They will also streamline product import, receipt, storage, packaging and labeling, release, shipment, return and destruction timelines.
“Through this center, we can customize sourcing and distribution strategies for customers in ways that are efficient, robust and compliant with local regulations,” said Thomas Senderovitz, SVP, Clinical Research Services, Parexel. “In addition, from this central location, we can provide responsive, timely delivery services to all EU destinations.”
South America
The new depots opening in South America add to the more than 50 owned or in-network depots and three regional distribution centers.
“This network helps ensure uninterrupted flow of materials and timely clinical site supply delivery to support clients’ clinical trials around the world,” Barnett said.
She added: “To conduct trials efficiently, the biopharmaceutical industry relies on highly specialized, complex supply and logistics services for studies that can span dozens of countries and hundreds of sites…Our new depots in Buenos Aires and São Paolo are part of our growing system to meet the needs of our customers and help them bring new and innovative drugs to market to improve the health and well-being of patients around the world.”
