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

With the increase in global regulation, there is a greater need for innovative study designs. Our multilingual team is trained in ICH-GCP as well as ISO 14155 and able to support the full lifecycle of regulatory approvals and monitoring. With over 100 years of combined experience, we are one of the most talented teams in the medical device clinical research market. Backed up by our accredited QMS system, we can ensure the quality is maintained regardless of the size and location of your study.

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. 

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