Assay Development & Validation

Clinical trial assays often change over the course of a trial, requiring a diagnostic partner that can closely manage these changes.

ICON has considerable expertise developing and validating methods that meet the specific needs of your clinical trials. This expertise spans all classes of investigational products including small and large molecule, and cell and gene therapy.

We also enable compliance to multiple requlatory requirements including GLP (e.g., PK, PD and ADA), CAP/CLIA/IVDR, CDX, RUO and performance evaluation studies. Our teams ultimately focus on the validation of regulatory compliant analytical methods across numerous technology platforms (immunoassay, IHC, flow, chemistry, LC MS, ddPCR, NGS, etc.) and specimen types (serum/plasma, CSF, whole blood, PBMC, bone marrow, saliva, core biopsies, fine needle aspirates, FFPE etc.) that assure high quality analytical data that is optimised for analytical precision, analytical accuracy/bias, minimisation of less than/greater than values and absence of cancellations.

Delivering benefits to your trial:

ICON's validated methods enable drug developers to efficiently and accurately assess the efficacy and safety of their investigational product.

Contact us to discuss how our assay development and validation solutions can aid the progress of your pipeline.

Clinical trial assays often change over the course of a trial, requiring a diagnostic partner that can closely manage these changes.

Delivering benefits to your trial:

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