Reliable LogisticsSpecimen management services begin with providing fully assembled IATA compliant specimen shipping systems with pre-printed return air waybills for a variety of shipping temperatures from ambient to dry ice. CLI coordinates the shipping of specimens from the investigator sites to the laboratory then tracks the shipment to ensure timely and safe transfer of collected specimens.
For each specimen shipment, CLI can prepare electronic inventory manifests of specimens shipped, liaise with investigator sites and the laboratory to resolve specimen discrepancies, and reconcile the number of collected specimen shipped by the investigator sites versus those received by the laboratory. CLI can review all specimens shipped for each subject / patient to identify missing specimens; CLI will liaise with investigator sites and laboratory to locate missing collected specimen(s).
CLI offers short-term and long-term specimen repository options through a partnership with a GLP compliant laboratory. Specimens can be stored at ambient temperature, -20ºC or -80ºC environments. Freezers are supported by emergency backup systems and each freezer is independently monitored 24/7 by a 21 CFR 11 compliant monitoring system. 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.
CLI offers services similar to central labs for studies where safety assessments are done locally at the investigator sites.
CLI logistics help:
- Attain nearly 100% specimen recovery and prevent lost specimens with individual shipment specimen tracking augmented with immediate remedial actions to locate missing specimens
- Reduce lag time between specimen collection and the availability of analysis data through the option of shipping specimens directly to assay laboratory
- Avoid delayed shipments and thawed specimens by providing IATA compliant, temperature controlled ready-to-ship specimen shipping systems
- Offer a cost effective alternative to central lab services