11.11.14
PAREXEL International Corp. has opened its new European Coordination Hub and Distribution Center in Berlin-Schonefeld, Germany. The facility expands the company's capacity to provide clinical trial supply and logistics services to support local, regional and global trial requirements. Capabilities include coordination of clinical trial supplies, ancillary supplies and central lab services.
The facility has more than 65,000 cubic meters of storage space, offers lab-kit assembly, and provides storage and distribution of ancillary materials. The new hub and distribution center 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, product import, receipt, storage, packaging and labeling, release, shipment, return and destruction timelines.
"To safely and efficiently conduct clinical trials, our customers need highly specialized clinical supply and logistics services for studies that can span dozens of countries and hundreds of sites around the world," said Mark A. Goldberg, president and chief operating officer, PAREXEL. "Our new European distribution center reflects a commitment to simplify the important end-to-end supply-management aspect of the drug-development journey."
PAREXEL also is opening new full-service clinical trial supply depots in Buenos Aires, Argentina, and Sao Paulo, Brazil. PAREXEL’s global system includes more than 50 depots and three regional distribution centers.
The facility has more than 65,000 cubic meters of storage space, offers lab-kit assembly, and provides storage and distribution of ancillary materials. The new hub and distribution center 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, product import, receipt, storage, packaging and labeling, release, shipment, return and destruction timelines.
"To safely and efficiently conduct clinical trials, our customers need highly specialized clinical supply and logistics services for studies that can span dozens of countries and hundreds of sites around the world," said Mark A. Goldberg, president and chief operating officer, PAREXEL. "Our new European distribution center reflects a commitment to simplify the important end-to-end supply-management aspect of the drug-development journey."
PAREXEL also is opening new full-service clinical trial supply depots in Buenos Aires, Argentina, and Sao Paulo, Brazil. PAREXEL’s global system includes more than 50 depots and three regional distribution centers.