SECTION 2
Co-developing a companion diagnostic and conducting thorough dose optimization studies are but two of the regulatory challenges facing precision oncology drug developers. Sponsors can de-risk their interactions with regulators by systematically removing uncertainties and finding the most efficient, least burdensome regulatory path.
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The vision of precision oncology—to treat each patient with the exact right medicine—is within reach yet still remote. We will move closer to the long-term vision by solving practical short-term problems and prioritizing innovation. At Parexel, we navigate multi-omics profiling, biomarkers, dose optimization, clinical trial site selection, companion diagnostics, regulatory strategy, and commercialization one challenge at a time while staying focused on improving the patient journey, our North Star.
Our oncology-focused patient advocates, scientists, statisticians, and former regulators are proud to partner with sponsors to advance precision oncology.