Clinical Logistics partners with a GLP compliant laboratory

Clinical Logistics is pleased to announce the introduction of specimen storage services through a partnership with Gentris Corporation (Gentris), a GLP compliant laboratory, located in Morrisville, North Carolina.

Gentris offers storage of DNA, RNA, whole blood, FFPE tissue blocks, urine, plasma, serum, saliva, liver cells, and buccal cells specimens. Specimen storage at the following storage conditions is available:

• Ambient (20 to 25 degrees C)

• Refrigeration (2 to 8 degrees C)

• Frozen (-20 to -80 degrees C)

Gentris' storage facility houses -80 degree centigrade freezers. Each freezer has a capacity of 57,600 2ml tubes, supported by multiple backup systems and an inventory tracking system. Each freezer is independently monitored 24/7 by a 21 CFR 11 Compliant Elpro Monitoring system. All freezers have redundant and emergency backup systems.

An integrated 21 CFR 11 compliant LIMS system is used to ensure proper chain of custody from the moment specimens are received. Specimen handling processes are in accordance with GLP regulations and meet the audit trail requirements.

This partnership enables Clinical Logistics to offer specimen storage services for clinical trials which require short, medium or long term storage. Stored specimens can be shipped in aggregates to the bioanalytical laboratory for analysis. Clinical Logistics will continue to offer oversight to ensure specimens are shipped in a timely manner and arrive safely at their destinations. In conjunction with this added service, Clinical Logistics will continue to coordinate shipment of time sensitive specimens from the clinical sites directly to bioanalytical laboratory to enable expedited specimen analysis.

Gentris and Clinical Logistics will be initiating their partnership at Biorepositories 2009 in Philadelphia September 21st - 23rd.