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.
Late stage development
Assay verification and validation
Roche Personalised Healthcare Solutions (PHCS)’ rigorous, disciplined approach to assay validation and verification maximizes probability of successful IVD development.
Registrational trial support
With 340+ clinical trials and 65+ global IVD registration studies underway, our adeptness at clinical trial support helps our partners meet their timelines and bolster their programs’ probability of success.
Regulatory submission planning
We take a flexible, early approach to regulatory strategy aligned with drug development timelines, drawing on our global & local 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
To ensure product development efforts are informed by real-world insights, Roche PHCS leverages the expertise of globally respected scientists, medical experts and key opinion leaders who are active in the scientific community and knowledgeable about the latest discoveries and innovations coming to market.
Regulatory advantage
Our global and local regulatory teams span across more than 55 countries and specialize in all stages of assay, IVD and CDx development. We bring deep expertise to help navigate global regulatory planning and submissions to remove barriers to approval.
Marketing strategy & access
Unparalleled access to lab leaders, pathologists and clinical professionals across the globe enables accelerated adoption and visibility among key decision makers. We’re skilled at developing strategies that help expand and expedite access to clinicians and patients.