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Clinical Trials Services

YCRG provides comprehensive clinical trial development and management services. Clinical research and device development experience includes First-in-Man, regulatory CE Mark and IDE/IND phase II and III trials, and post market and investigator-initiated clinical programs. Select a service below to learn more:

Summary

  • YCRG provides comprehensive clinical trial development and management services in a wide array of clinical trial classes.
  • YCRG has extensive experience guiding the development of cardiovascular devices and pharmaceuticals through all stages of regulatory evaluations worldwide.

  • YCRG offers the Clinical Events Committee to enable the independent adjudication of clinical events, conforming to regulatory requirements within single or multi-center, national or international clinical trials.

  • YCRG offers comprehensive Data Safety Monitoring Board (DSMB) services to ensure the ethical conduct of clinical trials and to protect the rights and safety of patients enrolled in the trial.

  • The Yale Cardiovascular Research Group provides comprehensive medical writing and editing services to support all stages of product development and all phases of clinical trial design and dissemination
  • Biostatistics

    YCRG provides expert statistics support for industry and academic sponsored clinical trials and projects.

  • Data Management

    YCRG provides comprehensive FDA-compliant data tracking and management services to deliver complete trial results.