Clinical Affairs

Cooperation, Coordination and Compliance

Conducting Clinical Studies is one of the largest expenses of getting an emerging device to market. Developing a Clinical Evaluation Plan, executing it to meet commercial milestones and delivering valued analysis for commercialization is our expertise. Lack of cooperation, coordination and complaince during this process is what causes unnecessary waste. We know it takes time to build genuine trust but our starting point is real and open dialogue about your Clinical Affair service needs.

How we can help

As a medical device Contract Research Organization (CRO), Qmed Consulting offers the following comprehensive selection of strategic consulting services for all types of medical device & IVD clinical studies.

Clinical Services

  • Clinical research strategy
  • Interim clinical affairs management
  • Clinical protocol writing
  • Contract negotiations
  • Project management
  • Clinical trial submissions
  • Clinical monitoring
  • Data management and EDC
  • Site selection & qualification
  • Patient recruitment
  • Investigator meeting management
  • Site payment
  • Device tracking
  • Clinical safety committee management: DMC, DSMB & CEC
  • SAE reporting/management
  • Study design and statistical analysis
  • Medical writing
  • IVD clinical performance testing
  • Site auditing
  • GCP training