ISSUE NO. 23 — Robust Sample Management for Reliable Study Results
The quality of study data depends on a rigorous sample management process that safeguards the integrity of samples at every step, from initial specimen collection through bioanalysis, to post-study storage. A CRO partner that conducts both preclinical and clinical studies, and supporting bioanalysis, ensures continuity of processes, knowledge sharing, and a centralized location for long-term storage of all your samples.
Issue 23 of The Altascientist provides a deep dive into:
- sample collection and storage conditions
- standardized workflows for risk Management and chain of custody
- stability testing
- laboratory management
- customized processes
- management of bioanalytical matrices
- post-study sample management
Why Does Sample Management Matter?
The proper handling of specimens (obtained from the trial participant) and samples (prepared for lab analysis), and their precise, timely treatment is crucial for reliable, robust data, and good decision making. When making a go/no-go decision for a new therapeutic, there must be certainty that the data which informs the decision is of the highest accuracy.
At both the bioanalytical site and the clinical site, meticulous workflows for safeguarding samples must be in place. Careful recording and storage of the samples, according to the study protocol and all relevant regulations and guidelines (e.g., GLP, GCP, ICH), is integral to the successful collection and analysis of trial data. Well-trained staff, managed by a dedicated bioanalytical Principal Investigator with a clear mandate to safeguard the integrity of the data, is a valuable asset.
Sample Collection and Storage Conditions
Preclinical studies and clinical trials can involve many different sample types, in a variety of storage containers. The sample containers for storage below -80 °C are specially developed with materials that retain their integrity under such conditions—a plastic cap that can be refrigerated may not withstand temperatures below -80 °C. Likewise, the container for a different type of sample and temperature will have its own qualities, specific to the situation. The necessity for adding stabilizers, anticoagulants, or other preservatives, either after collection or before bioanalysis, also varies depending on the specifics of each trial.
A comprehensive sample collection manual should be provided to the trial sites, detailing every requirement to ensure that all study personnel are fully proficient at maintaining specimen integrity. Flexibility to accommodate many variables with an equally rigorous workflow, and a readiness to learn and adopt the latest technologies, are key to a comprehensive sample management system that adapts to every sponsor’s needs.
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