Clinical Studies and IDE's

Many times it is necessary to perform human clinical trials, or studies, to obtain approval to legally market a product. These trials are performed to demonstrate that the device is safe and effective for human use. Results from such studies can be included in FDA submissions. The FDA and EU regulate the procedures for conducting clinical investigations of medical devices. Regulatory Specialists, Inc. has coordinated numerous clinical studies within the United States and throughout the world.

Clinical Services

• Protocol Preparation
• Case Report Forms (CRFıs)
• Statistical Design
• Investigator Identification
• IRB Approvals
• IDE Approvals with the FDA
• Investigator Training
• Clinical Trial Monitoring
• Interim and Final Reports
• Statistical Reviews of Data
• Reports for FDA submission
• Clinical Trial Audits