Good clinical research involving new medical technology is strictly regulated.
GKF has a very extensive track record in performing and supporting preclinical and clinical research utilizing and / or testing new technology.
GKF can support both projects and start-up companies developing new medical technology who wants to reach a fast solution.
GKF provides support in:
Clinical research
– setting up research projects
– providing guidance or complete documentation for application to the Regional Ethical Committee (REC) and the Regulatory body
– running projects
– analyzing results
– monitoring projects
– reporting
Regulatory affairs
– Supporting regulatory requirements
– QMS-systems
– PRRC qualified
– Intellectual Properties (IP)
Mentoring
– Supporting managers in startups and small businesses.
– PRRC for hire.
– Contract negotiations