Clinical Trials: Bioanalytical Testing and Storage

Best Practices for Method Cross-Validation Between Central and Local Labs

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In global clinical trials, sponsors often engage both central laboratories and local site-based laboratories for sample analysis. While central labs offer consistency and validated methods, local labs may be used for logistical convenience, urgent testing, or regulatory requirements. This dual-lab setup introduces challenges in method comparability, data reliability, and regulatory compliance.

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Bioanalytical Testing and Storage, Laboratory and Sample Management

Bridging Studies for Changing Analytical Methods During Trials

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In long-duration or multi-phase clinical trials, sponsors may find it necessary to change or upgrade the bioanalytical method used to analyze biological samples. These changes may be driven by improved assay sensitivity, revised biomarker panels, lab transitions, or regulatory updates. However, such transitions raise critical questions about data continuity and comparability.

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Bioanalytical Testing and Storage, Laboratory and Sample Management

Sample Re-Analysis Procedures in Bioanalysis: Inspection Readiness Guide

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Bioanalytical laboratories supporting clinical trials routinely encounter scenarios where test results may be flagged for potential re-analysis. These may include unexpected values, assay drift, out-of-specification (OOS) results, or stability-related deviations. Re-analysis refers to repeating the sample test using the same validated method to confirm or clarify the original result.

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Bioanalytical Testing and Storage, Laboratory and Sample Management

How to Handle Analyte Instability in Stored Samples – CAPA and Risk Mitigation

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Bioanalytical sample integrity is vital to the success of clinical trials, particularly when evaluating pharmacokinetics, drug efficacy, or biomarker data. Analyte instability—defined as the degradation or transformation of a substance within a stored biological matrix—can compromise data validity and trigger regulatory scrutiny.

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Bioanalytical Testing and Storage, Laboratory and Sample Management

Handling Long-Term Storage Failures in Bioanalysis – Regulatory Expectations and CAPA

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In regulated clinical trials, bioanalytical samples must be stored under validated and documented conditions to preserve analyte integrity. Long-term storage failures—whether due to temperature excursions, equipment malfunction, or procedural errors—can jeopardize data integrity and lead to regulatory observations. These failures often go unnoticed until re-analysis, regulatory inspection, or sample shipment triggers a deviation report.

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Bioanalytical Testing and Storage, Laboratory and Sample Management