Three costly mistakes to avoid with your assay design when approaching clinical trials

The Inserm We-Met platform, part of the French National Institute of Health and Medical Research, specializes in advanced functional biochemistry and high-resolution protein characterization. Leveraging cutting-edge technologies such as capillary electrophoresis and microfluidic systems, We-Met enables ultra-low sample consumption while maximizing analytical sensitivity and reproducibility—key parameters for robust assay development in clinical research.

This presentation will outline three high-impact errors that can compromise assay integrity and escalate costs in terms of time, resources, and sample availability:

1. Sample Handling and Pre-Analytical Variability: From collection at investigator sites to biochemical extraction, improper sample preparation introduces systematic bias and jeopardizes downstream data quality.
2. Reagent and Method Validation: Ensuring compliance with regulatory frameworks and guidelines such the ICH guideline M10 on bioanalytical method validation from EMA (European Medicine Agency) or FDA (U.S Food & Drug Administration), critical for assay reliability and regulatory acceptance.
3. Quantification Accuracy and Reproducibility: Establishing rigorous controls for precision and reproducibility is essential to meet clinical trial standards and avoid costly rework.

Drawing on our experience in developing and validating complex assays—including one targeting a hexameric protein implicated in multiple sclerosis and post-COVID syndromes—we will provide a structured roadmap for mitigating these risks within an evolving regulatory landscape.