Late stage development
In late stage development, we prepare and provide support for registrational and pivotal trials with an investigational assay, while conducting regulatory submission planning and preparation.
Assay validation and verification
The assay and raw materials are validated and verified, and the investigational assay kit is developed, including the scoring algorithm, control slides and training materials.
Registrational trial support
With 250+ ongoing studies, our adeptness at clinical trial support helps our partners meet their timelines and bolster their programs’ probability of success.
Regulatory planning and submission
We take a flexible, early approach to regulatory strategy aligned with drug timelines, drawing on our regulatory expertise to determine the best approach for each partner.
CASE STUDY
Bridging the path to CDx success
Find out how we enabled significant access to personalized therapy for cancer patients.
Medical and functional excellence drives our success
Strength in science
Our deep bench of experts includes an oncologist and 30+ pathologists who help ensure product development is informed by the latest medical and scientific developments and discoveries.
Regulatory advantage
With a global team of 15+ experts who specialize in all stages of CDx projects, we bring extensive knowledge and more regulatory experience than any other provider.
Marketing & market access
Dedicated global and local teams deliver launch excellence to build awareness, ensure market readiness and facilitate rapid patient access.