How a LIMS Helps Manage the Entire Specimen Life Cycle & Meet Clinical Regulatory Compliance

Clinical sample management, particularly for multi-centred trials, has been a challenge for every trial leader for many years and the advent of ever more complicated biomarker sampling has increased the burden further. Aside from the ethical responsibility to look after every patient’s samples, in order to comply with GLPC guidelines, Sponsors have to demonstrate full traceability from the point of sample collection, during transportation, at the analysis lab until finally being transferred to long term storage or destroyed.  Every individual aliquot must be reconciled with the Trial Master File, which typically amounts to numbers exceeding tens of thousands.  Manual process, therefore, leave the door open for errors. This presentation describes how the integration of a LIMS system can simplify your clinical sample workflows and ensure GLPC compliance.  The pitfalls are explored before examining each stage of the sample lifecycle with examples of how LIMS can automate and provide robust processes. The author pulls on a 30-year career in the clinical trial industry to present this overview.

Learning Objectives:

1. Understand the regulatory requirements for clinical sample tracking.

2. Identify the pitfalls of sample tracking during the sample life cycle.

3. Understand how LIMS can alleviate the pitfalls and ensure regulatory compliance.