Clinical Trial Assay Development and Validation – Strategies for Success


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Almac Diagnostic Services can help bring your biomarker to the clinic.

Almac has substantial experience of analytical validation across all stages of diagnostic test development from utilisation in early proof of concept trials through to IVD Companion Diagnostic (CDx) tests.


This webinar will highlight the strategic approach required for the development & analytical validation of clinical trial assays at each stage of clinical validation to ensure the highest quality molecular data is acquired in the most efficient way whilst minimising the potential risk of product redesign for Biopharma companies.


  • Key considerations in the development & validation of CTAs for clinical stratification
  • The importance of adequate specimen collection & stabilisation
  • Major factors influencing platform selection
  • The requirement of bridging studies and lessons learned
  • Challenges of demonstrating adequate analytical performance of panels
  • Considerations for data analysis pipelines

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