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Clinical Trial Assay Development and Validation: Strategies for Success
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"Clinical Trial Assay Development and Validation: Strategies for Success"

Molecular biomarkers offer tremendous potential to classify patients into subgroups of relevance for prognostic and predictive utilities. However, there are many challenges and considerations in translating a biomarker to a molecular diagnostic test. When defining the intended use of novel biomarkers, decisions including specimen collection, molecular content, and platform selection can have a significant impact on a biomarker program.

A strategic approach to the development and analytical validation of clinical trial assays at each stage of clinical validation ensures the highest quality molecular data is acquired in the most efficient way while minimizing the potential risk of product redesign for biopharma companies.

Almac Diagnostic Services has substantial experience in analytical validation across all stages of diagnostic test development from utilization in early proof of concept trials through to IVD companion diagnostic tests, often consulting to help guide biopharma companies through the process.

This on-demand webinar from Almac highlights a series of case studies to explore the strategic considerations at each stage of the development and validation journey to ensure that assays are both robust and compliant with appropriate global regulatory frameworks for prospective clinical trial stratification.

Participants will learn about:

  • Key considerations in the development and validation of assays for clinical stratification.
  • The importance of adequate specimen collection & stabilization.
  • 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.


Offered Free by: Almac Group
See All Resources from: Almac Group

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