Offering a Full Spectrum of Clinical Consulting Services

Experience in the following fields:

• Ablative therapies
• Cancer diagnostics
• Cardiovascular implants
• Critical care
• Electrophysiology
• Hemodialysis
• Neurosurgery
• Orthopedics
• Robotics
• Structural heart
• Wound care

• Site identification and solicitation of competitive quotes
• Protocol development
• Management of Good Laboratory Practices (GLP) and non-GLP studies in the Study Director role
• Compose study reports for future regulatory submissions

• Author and review study protocols
• Obtain regulatory and IRB approvals
• Perform site training
• Coordinate data management
• Manage study sites 
• Serve as principle liaison with CROs
• Provide expertise in US and OUS studies
• Develop economic analyses

• Author FDA pre-submissions
• Prepare 510(k) and IDE submissions
• Apply for Breakthrough Device designation
• Apply for Humanitarian Device exemptions 
• Represent clients at FDA meetings

• Author and update Clinical Evaluation Reports (CERs)
• Create clinical SOPs
• Prepare clinical study reports
• Author peer reviewed publications

• Serve as an Expert Witness in device litigation matters
• Review and analyze trial documentation
• Author Expert Witness reports
• Testify in court proceedings