Diagnostic Development & Validation

Through decades of experience we bring real-world knowledge to advance your goals faster.

Our Diagnostic Development & Validation expertise and services include:

Defining the diagnostic strategy:

Increase the probability of a positive endpoint for the therapeutic product to support differentiation and enhance value.

Clinical trial design & execution:

Designing and executing clinical trials to evaluate the analytical and clinical validity of companion diagnostics alongside the therapeutic product.

Regulatory strategy & submission

support: Developing regulatory strategies for companion diagnostics, including navigating the approval process and preparing required regulatory submissions.

Biomarker discovery & assay development:

Discovering and validating biomarkers used in patient selection and define who are most likely to benefit from a specific therapeutic product.

Diagnostic partner management

Identification and selection of appropriate diagnostic partner(s), assistance with contract negotiation and oversight to diagnostic partner to ensure timely and cost-effective delivery of diagnostic product.

Commercialization & launch support:

Developing commercialization plans for companion diagnostics, including market access strategies, pricing and reimbursement considerations, and launch activities.