Integrated Assay Development and Technology Transfer for Global Clinical Programs

Fit-for-purpose validation aligns the level of validation with how the assay data will be used. For example, assays supporting exploratory biomarkers may require a different validation approach than those used for primary clinical endpoints. We tailor validation strategies to your study objectives, ensuring that data is robust, reproducible, and appropriate for its intended use.

Technology transfer is the process of moving an assay from one laboratory to another while maintaining consistent performance and data quality. It involves standardizing protocols, training teams, and verifying performance across sites. This is essential for multicenter and global studies, where comparable results across laboratories are critical.

We develop and validate a wide range of assays across immunological, molecular, virological, and broader biomarker applications. Whether you are working with a novel biomarker or adapting an existing method for a new study, we design assays aligned to your clinical endpoints and program objectives.

We ensure consistency through harmonized SOPs, standardized validation procedures, and aligned analytical approaches. Combined with laboratory onboarding, training, and transfer verification, this ensures assays perform consistently across all sites in a global program.

Assay development can begin as early as preclinical and translational stages, but early engagement is critical. Defining assay strategy, feasibility, and validation requirements upfront helps avoid delays and ensures assays are ready for use when clinical studies begin.

Dedicated project management ensures assay development and transfer activities stay aligned with study timelines and objectives. This includes coordinating cross-functional teams, managing documentation, and maintaining clear communication throughout the program.