Protocol and Report Writing

Overview

The Yale Cardiovascular Research Group provides comprehensive protocol design and writing services, as well as report writing services to fulfill regulatory requirements and widely disseminate the knowledge generated from clinical trials.

Expertise

All YCRG writing services are performed by trained medical writers and supervised by Cody Pietras, a Medical Editor with more than 8 years of experience in the field of cardiovascular clinical research.

Medical and regulatory oversight are provided by Dr. Lansky, who has authored over 300 peer-reviewed publications and has extensive US, EU, and Asia pacific regulatory experience, and Ms. Gambone, who has more than 20 years of experience in clinical trial documentation and regulatory submissions in the US and worldwide.

Writing services provided by YCRG include:

  • Clinical trial protocols,
  • Literature reviews,
  • Investigator brochures,
  • Clinical study reports,
  • Regulatory reports,
  • Peer-reviewed manuscript preparation and editorial services, and
  • Consumer-directed educational and promotional materials.