NDA-Enabling Studies

For over 25 years, we have been designing and running a broad range of early phase studies required for NDA submissions. We are experts in the design and conduct of early clinical development plans and stand-alone studies. Our integrated manufacturing and analytical capabilities ensure timely availability of clinical supply, and pharmacy on demand delivers fast, accurate adaptations should they be required. Our success is greatly attributed to our focus on safety and quality, our ability to recruit and retain healthy normal volunteers and patient populations and our fully integrated supporting services in program management, bioanalysis, medical writing and more.