Regulatory Services:

• Clinical and regulatory development plans
• Clinical trial design
• FDA communications
• Pre-IND and Pre-IDE meetings
• Investigational new drug (IND) and investigational device exemption (IDE) submissions
• Premarket notifications
• Premarket approval application (PMA) submissions
• New drug applications
• Humanitarian use device (HUD) and device exemption (HDE) submissions
• Combination products and request for designation (RFD)

Specialized Services:

• Review and reporting of serious and unanticipated adverse events to the FDA
• Preparation for Advisory Committee review of PMAs/NDAs
• Management of Data Safety and Monitoring Boards (DSMBs)

Clinical Database Development:

•  Clinical database development in compliance with FDA guidance for computerized systems for use in IDE/IND clinical trials
• Databases for marketing studies
• Data management (double-data entry and verification; queries to clinical sites with deficiency audit trail)
• Statistical analyses of clinical data for clinical reports, annual progress reports, INDs, IDEs, PMAs, NDAs, publications, presentation, white papers