Navigating medical device regulations can be challenging and understanding the role of clinical investigation in medical device and technology development time consuming. We specialise in clinical investigation development and forging clinical partnerships to support evidence generation of your innovation. Our service will enable you to determine if a Clinical Investigation is necessary for your medical technology and, if so, assist with:
- Collaboration and partnership opportunities with relevant clinicians
- Costings and timelines
- Clinical Investigation planning and design, inclusive of protocol development
- Clinical Investigation set up using the Integrated Research Application System (IRAS) and Research Ethics Committee (REC)
- Study set up, delivery and monitoring
