Clinical

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