At Paul L Clark & Associates, we have 20+ years’ experience managing and reviewing clinical research studies for MedDev products in accordance with Good Clinical Practice (GCP) and the US Investigational Device Exemptions (21 CFR 812). We can help establish a global clinical strategy that aligns with your regulatory and marketing strategies. Our experience covers a range of pre-market trials required for international regulatory approvals, and post-market studies designed for marketing and promotion. Our network includes a number of Clinical Research Organizations (CROs) based in the US, ANZ and Europe. We have the capabilities to offer a range of clinical research services, including:

  • Clinical strategy and study oversight
  • Clinical study project and budget management
  • Development of protocols, CRFs, Investigator Brochures, project plans, and other trial documentation
  • Preparation of Ethics / IRB submissions
  • Clinical marketing strategies and planning
  • Post-market feedback & data analysis
  • Scientific Advisory Boards and identification of key opinion leaders (KOLs)
  • Preparation of abstracts and manuscripts for presentation at conferences and submission to peer review journals