Diagnostic laboratories and CROs now routinely engage in the collection of samples from global markets. Managing cold chain logistics to ensure that specimen integrity is maintained from multiple and disparate collection sites can be complicated and burdensome on your organization. The clinical supply chain creates a challenging distribution environment when the requirement is to ship specimens under frozen conditions worldwide, while maintaining and documenting appropriate environmental conditions. Given the great number of clinical sites, there is increased complexity for maintaining product quality and mitigating the risk of thermal excursions.
Until now, this has created an additional need for personnel to work with specialty couriers, contracted depots, and shipper manufacturers. CryoPort Express® can minimize the risks of failure in the cold chain distribution process; risks that occur when there are adverse temperature changes during storage, handling, or distribution which causes a number of serious problems:
- A lack of compliance with global regulatory and standards-based requirements can increase liability
- Thermal variability can lead to inconsistency of results between and within batches
- The shipment can be rejected by the quality department therefore leading to costly delays – increasing the complexity of trial management and loss of revenue
