Assay development and validation
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Robust assay development—validated to meet your study and regulatory needs
We support Sponsors with laboratory assay development and validation, delivering reliable, fit‑for‑purpose bioanalytical methods to support clinical research at all phases. Our scientists design and optimize assays tailored to the specific biomarkers, matrices, and performance requirements of each study, with a strong focus on customized validation strategies. Validation scopes and acceptance criteria can be adapted based on study objectives, development stage, and sponsor or regulatory expectations, with methodologies aligned to internationally recognized guidelines, including EMA, FDA, and ICH. This flexible, science‑driven approach ensures robust assay performance, data confidence, and seamless integration of bioanalytical results into clinical programs.
Validations
Central Laboratory
Services
Assay Development and Validation
*Robust assay development—validated to meet your study and regulatory needs
Biorepository and Samples Storage
*Protecting valuable samples—today and for the long term
Biostatistical support
*Biostatistical expertise that turns complex assay data into confidence
Data Management
*Data management built for integrity, traceability, and inspection readiness
Kits Production
*From concept to clinic ready kits, we make sample logistics seamless
Label Printing
*Clear, compliant labels—accurately produced, every time.
Pre-clinical Services
*Robust pre clinical support — performed in the U.S. and replicated in Europe
Project Management
*End to end project management—driving your studies from concept to completion
Protocol Review
*We help sponsors get the lab right—before the study starts
Samples Shipment
*Reliable global sample shipment, handled with precision
Scientific Support
*Expert scientific support—translating laboratory data into actionable insight.
Tech Transfer
*Seamless technology transfer—built on expertise, consistency, and global alignment
Trainings
*Targeted laboratory trainings—empowering teams through hands on expertise
