Peer-reviewed publication by Chris Tudan, PhD
Director, Biochemistry & QA, Veloxity Labs
Published in Medical Research Archives, European Society of Medicine
Overview: Clinical bioanalysis operates at the intersection of Good Clinical Practice (GCP), bioanalytical method validation requirements and the practical realities of analyzing clinical study samples. As regulatory expectations continue to evolve, questions remain about how GCP principles should be interpreted and operationalized within the bioanalytical laboratory.
In this paper, Chris Tudan examines how evolving GCP expectations affect clinical bioanalytical laboratories and highlights areas where regulatory guidance and day-to-day laboratory operations do not always align clearly.
Clinical sample management
Considerations surrounding sample handling, traceability, chain of custody and informed consent.
Protocol adherence
How clinical study protocols and amendments extend into bioanalytical laboratory operations.
Randomization and blinding
Operational considerations for maintaining blinding and managing circumstances where unblinding may be required.
Data integrity and computerized systems
The role of fit-for-purpose systems, qualification and audit trails in supporting reliable clinical bioanalytical data.
Deviations and reporting
How deviations, communication and reporting responsibilities intersect across laboratories, sponsors and clinical study teams.
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