The data that lies within biological samples hold the keys to the success of a clinical trial. An important aspect of a clinical trial is therefore the collection of samples and their careful preservation. As biological samples often degrade between the time they are collected and when they are tested, it is crucial to have a trustworthy storage process in place which preserves sample integrity over time. Read on to learn the key factors to successful biological sample storage.
The correct handling of biosamples has an impact on both the course and the results of clinical trials. External biospecimen repositories can act as an extension to your trial's operational and storage needs, ensuring that your project runs as smoothly as possible.
When selecting a biorepository service provider, it is essential to establish that they have the following capabilities:
1. Monitoring/alert services:
Timely communication and 24/7 monitoring are essential when dealing with biological samples. You and your service provider’s teams need to be alerted immediately if there is a problem with a sample or the logistics of the sample (ex: temperature drop).
2. Contingency plan:
Your samples must be safe at all times, so having a full contingency plan at the onset of a trial is crucial. Your biorepository provider should offer a backup storage system powered by emergency backup generators. This avoids the risk of data/sample loss.
3. Compliance with recent regulations:
21 CFR Part 11 and EU GMP Annex 11 compliance. 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES), while EU GMP Annex 11 is about all forms of computerised systems used as part of European Good Manufacturing Practice (GMP) regulated activities.
Extensive knowledge of identifying, collecting, storing, and distributing biospecimens over time for different clinical trials worldwide is key.
High-quality and standardised biorepository practices are required to guarantee the integrity and quality of your samples. Work with a provider who offers tailored solutions rather than a one-size-fits-all approach. This will ensure that your specific storage challenges and requirements are considered when developing a storage plan that suits the needs of your trial. By customising your biorepository services, your provider can streamline processes and ultimately reduce overall trial costs.
With over 25 years of experience in biological sample management, 3M+ samples stored in freezers in the US and the EU, Clinigen Clinical Supplies Management is an expert in transporting, storing, and handling biological samples. Clinigen’s biorepository services include storage infrastructure, flow and location management and data demographics. We offer services ranging from short- and long-term storage of biological samples collected during a clinical trial to the management of a client's entire biorepository.
Learn more about Clinigen’s tailor-made biorepository solutions.
As a leading provider on a global scale, Clinigen is committed to delivering fully integrated biological sample logistics solutions. With a 25+ year track record and 3M+ stored samples to date, we tailor our services to the exact needs of our clients.