First human use studies require a careful balance of program goals against the highest requirements of human subject safety.

Our clinical development professionals understand product safety best practices, standards, and requirements, and have designed and executed many first human use studies that comprehensively evaluate and monitor product safety and performance.

Our clinical studies are designed and conducted in full compliance with the latest, industry best practice Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), International Conference on Harmonization (ICH) Guidelines, and regulatory requirements across regions.