Clinical
- 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
Professional Education Consulting
- Helps to deliver quicker revenue and increased value through our internal team and external physician/HCP training
- Our customized comprehensive and strategic education programs create repeatable and scalable training systems for our clients.
- Strategic training development
- Procedure development
- Faculty/KOL development
Learning & Development
- Instructional design learning modules
- Clinical trial education/protocol adherence
- Create, facilitate, and lead training courses (classroom, virtual, and lab)
- Implement learning management systems (LMS)
- Create supplemental training tools (iPad/tablet content, video libraries, interactive training tools)
- Develop accountability measures & tracking tools (training verification/certification)
Regulatory
- Author FDA pre-submissions
- Apply for Breakthrough Device designations
- Represent clients at FDA meetings
Legal Affairs
- Serve as an Expert Witness in device litigation matters
- Review and analyze trial documentation
