
In this free webinar, gain insight into assay transfer best practices, including aligned protocols, reagents and instrumentation. The featured speakers will share approaches to demonstrate assay concordance across participating laboratories, including the strategic use of reference standards, quality controls and when available, real-world samples to evaluate site-to-site performance. Attendees will gain insight into fit-for-purpose statistical methodologies, including bias assessment and equivalence testing to interpret differences in bioanalytical assay performance.
TORONTO, June 29, 2026 /PRNewswire/ — The increasing globalization of drug development programs has driven a growing need for rigorous cross-validation of bioanalytical assays across multiple laboratory sites. As bioanalytical methods become increasingly used for pharmacokinetic, immunogenicity and biomarker assessments, which are key components of clinical studies, ensuring inter-laboratory concordance is essential to maintaining data quality and supporting regulatory submissions in accordance with current regulatory expectations. This webinar outlines practical strategies for achieving successful cross-validation across multi-site programs.
Robust assay cross-validation requires demonstrated equivalence in assay reliability, accuracy and precision across participating laboratories, with consistent performance against established acceptance criteria. Variability introduced by site-specific reagent lots, instrumentation or analyst interpretation can compromise assay comparability and introduce bias into downstream pharmacological or clinical conclusions.
The featured speakers will explore structured assay transfer protocols, approaches for evaluating inter-laboratory comparability using reference standards and quality controls and a review of fit-for-purpose statistical methods, including equivalence testing and bias assessment, for identifying and characterizing inter-site discordance. These strategies aim to support successful drug development programs in meeting both scientific and regulatory expectations for cross-validated assay performance.
Register for this webinar to learn how assay cross-validation strategies can reduce multi-site risk and support reliable bioanalytical data.
Join experts from BioAgilytix, Lynn Kamen, PhD, Executive Director, Scientific Office; Jessica Weaver, MRes, Associate Director, Scientific Officer; Pavan Prathipati, PhD, Manager II; Bryan M. Gullick, PhD, Senior Director, Molecular Bioanalysis; Michael Mullen, Scientist I; and Todd Lester, Senior Director, for the live webinar on Monday, July 20, 2026, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Strategies to Reduce Risk in Multi-Site Assay Cross-Validation.
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