During clinical trials, thousands of biological samples (biospecimens) are collected, usually at different places at different times. The samples are analysed either during the screening phase of the study, in order to include or exclude subjects, or after the administration of the product, in order to assess primary or secondary endpoints.
Improper biospecimen management can involve missing or mixed up samples, missing data, delays in reporting results, and poorly organised biospecimen logistics. This mismanagement can dramatically affect the outcome of a clinical trial, leading to higher costs, patient drop-off, and other preventable problems.
Proper biospecimen management requires several elements, any of which can pose challenges. These necessary elements include:
While biospecimen management during clinical trials can be exacting and difficult, there are plenty of ways to surmount the obstacles through expert clinical supply services. The following are a few examples:
Sample collection kits are designed specifically for each study and each visit, and can be supplied to clinical sites along with all the associated documentation. This helps ensure correct biospecimen collection, preparation, and handling. Also, all of the shipping materials may be supplied to meet regulatory or temperature requirements, with preprinted airway bills.
A clear and unambiguous identification of each tube generated can be designed with a label for specific information and a bar code for complete traceability. These tubes may also be prelabelled.
Shipment and dispatch of biospecimens can present costly challenges. Through an experienced clinical supply services provider, the process can be optimised to reduce the cost of transportation and improve overall trial efficiency.
Samples can be centralised before use to allow the generation of a consolidated and verified list. A well-planned logistics strategy for biomedical samples collected during clinical trials is essential to cutting costs and optimising quality.
Learn more about streamlining your clinical trial with our guide to biological sample management.
As a leading provider on a global scale, Clinigen is committed to delivering fully integrated biological sample logistics solutions. With a 20+ year track record and 3M+ stored samples to date, we tailor our services to the exact needs of our clients.