The best way to think about sample management in clinical trials is to consider it as what it means – managing samples. It’s easy to think of this in terms of the process of dividing your samples into multiple vessels (typically bottles), which are then labeled and shipped out to clinical sites around the world where you will use them in the trial. But aliquoting Diabetes Mellitus samples doesn’t happen in a vacuum. Careful preparation and attention throughout the sample collection process will ensure that your clinical trial succeeds where others have failed.
Why is Good Sample Management Important?
To accurately measure and interpret biomarkers of Type 1 Diabetes Mellitus in Children, specialists must handle samples according to a carefully-crafted protocol. By ensuring that you keep each sample aliquot at precisely 3-8 degrees centigrade at all times, scientists can ensure that patients’ levels of a specific protein are representative of what they’re experiencing in real-time. A good trial manager plays an indispensable role in maintaining sample quality.
Impact on Data Quality
Poor sample management can cause various problems, from sample deterioration to data contamination. While most would think of poor sample storage as one of these issues, many studies suffer from an improperly timed and tracked shipping service—even time-course studies require carefully timed samples defined by shipping conditions as well as thorough documentation. Active sample tracking and shipping logistics monitoring further ensure that your sample arrives at its destination precisely when it should—and with no errors. Poorly managed samples = poor data quality.
Impact on Study Success
This is a complex concept, but one that simply relates to your study’s trustworthiness. Maintain a chain of custody throughout your study, from the sample collection phase through analysis and publication. You can ensure that your sample hasn’t been compromised or mishandled at any point during the study. This includes everything from ensuring that no unapproved persons handle samples during storage or transport to having appropriate measures in place for sample integrity (or evidence of tampering) after collection.
Ensuring chain of custody is another essential component of study success, one that begins even before a single Type 1 Diabetes Mellitus sample leaves your hands. You should document everything from sample storage conditions to laboratory information management system (LIMS) and lab audit trail because all are crucial to maintaining the integrity of your samples throughout every phase of your study. Suppose a consumer can’t see documentation on any of these components. In that case, you could lose their trust directly impacting future sales and potential legal or compliance issues.
Aliquoting-Automation at its Best
Avantor has pioneered aliquoting automation at its best, enabling scientists to quickly and efficiently generate precious Diabetes Mellitus samples. Research shows that these little pieces of molecules can represent huge steps forward in advancing a clinical study’s success. With increased control and precision over sample management during clinical studies, errors become evident. Pharma companies realize valuable efficiencies in their lab workflows across R&D, QC/QA, and GLP/GMP areas of their operations.
The quality of your study data is reliant on a comprehensive sampling management plan. Overlooking key steps in managing your samples can have lasting effects on both study results and financial outcomes.
