Clinical Trial Design and Regulatory Strategy

Overview

The Yale Cardiovascular Research Group has extensive experience guiding the development of cardiovascular devices and pharmaceuticals through all stages of regulatory evaluations in the US, Canada, Europe, Asia Pacific, and worldwide.

Early regulatory interface and frequent communication ensure that all YCRG clinical trial development and management services are aligned with regulatory agency expectations, providing reliable timelines and smooth submissions to align with sponsor requirements.

In addition, Yale's extensive international partnerships ensure localized expertise to facilitate internationally-integrated regulatory strategy development and implementation.

Expertise

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 and CE-mark studies in Europe.

Regulatory consulting services provided by YCRG include:

  • Regulatory strategy development and implementation;
  • Protocol development in concert with health authority requirements;
  • Regulatory agencies representation;
  • Regulatory report writing and submissions; and
  • Post market surveillance.