Clinical Trial Design and Regulatory Strategy

Overview

YCRG excels at the complete clinical trial development process, from clinical strategy need to execution. We provide our clients with a single source for the scientific, clinical, regulatory, biostatistical, and trial management expertise necessary to produce high-quality and robust clinical trial protocols, case report forms, and other trial documentation. Our vast experience enables us to offer the well-considered endpoint selection, sample size justification, statistical analysis, study procedures, and definitions that are the foundation of a successful clinical trial program. 

YCRG leadership has provided FDA and Health Authority interface for a wide variety of clients at all stages of device and drug development cycles. Past interventional clinical trial expertise includes successful regulatory strategy execution for pivotal US trials via IDE, IND, and 510k pathways, as well as CE-mark studies in Europe. Yale's extensive international partnerships ensure localized expertise to facilitate internationally integrated regulatory strategy development and implementation. 

In addition, early regulatory interface and frequent communication ensure that all YCRG clinical trial development and management services are aligned with regulatory agency expectations, minimizing both cost and time-to-approval.