Pharmaceutical Clinical Study Design Services (CRO)

Clinical study design service providers plan and execute preclinical and clinical (Phases I-IV) programs associated with pharmaceutical product development and the securing of FDA approvals. Companies help sponsors navigate study design challenges across a wide variety of designs including first in human, novel drug therapies, first-in-class, efficacy, safety, non-inferiority, pharmacokinetic and pivotal trials.

Service providers help select, validate, qualify and provide oversight to ensure that study sites keep progress on time or ahead of schedule. Other services can include IND support, IRB compliance, pending NDA submissions and anticipated regulator inquiries.