Clinical studies are the backbone of evidence-based medicine. Whether a new drug, medical device or therapy is approved depends largely on the results of these studies. And the quality of the results stands and falls with the quality of the biological samples that are collected, transported and stored as part of the study.
In multicenter clinical trials - studies that are conducted simultaneously at several clinics in different cities or even countries - sample logistics become a highly complex challenge. Every blood sample, every biopsy and every tissue sample must be handled under exactly the same conditions, regardless of whether it was obtained in Berlin, Zurich or Istanbul.
Consarctic® offers customized cryogenic solutions for this challenge, which guarantee an unbroken cold chain from sample collection at the study site to long-term storage in the central laboratory.
Each study site has different equipment and differently trained personnel. Cryopreservation protocols must be robust and unambiguous enough to produce identical results regardless of location. Standardized freezers such as the BIOFREEZE® help to minimize variability between sites.
The collected samples often have to be transported from the individual test centers to one or a few central laboratories. The time and logistical requirements vary greatly: within a city, transportation can take hours; internationally, it can take days and involve customs clearance.
Good Clinical Practice (GCP) requires complete documentation of sample handling. This includes temperature monitoring throughout transportation, documentation of storage conditions and the traceability of each individual sample.
The Cryotransport containers of the Consarctic® ASR+ series are optimized for the validated transport of clinical study samples:
In the central laboratory, thousands of samples from different locations may need to be received, sorted and stored. A scalable cryobank is essential here.
An increasingly important aspect of clinical studies is the possibility of retrospective analyses. Samples that are obtained and cryopreserved today can be examined in five or ten years' time using analysis methods that do not yet exist today. This look into the future requires particularly reliable and long-term stable cryostorage.
Leading CROs (Contract Research Organizations) and pharmaceutical companies rely on the cryogenic products and services of Consarctic®. Our comprehensive portfolio - from controlled rate freezers to storage tanks and transportation solutions - covers the entire process chain of clinical trial samples.
Are you planning a clinical study and need a reliable cryoinfrastructure? Contact our experts for individual advice on sample logistics and storage strategy.