Clinical Affairs

Everything you need to know

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 meeting
We perform: First in Man, Pre-approval clinical investigations, Post Market Clinical Follow Up, Performance Evaluations and Registry studies.
Clinical Study Set-Up
  • Approvals/Submissions for Ethics and Competent Authority
  • Contract negotiations
  • Site initiation visits
  • Preparation of clinical documentation
  • Site Selection
  • GCP & ISO 14155 Training
  • Study design and statistical analysis
Clinical Study Live Phase
  • Data management and EDC
  • Clinical monitoring
  • Safety management
  • Clinical site Auditing
  • Interim analysis
Clinical Study Close Down
  • Close down visits
  • Final report