NIS and Clinical Development

NIS and Clinical Development

We currently notice an increase in requests to provide freelancers with a global expertise in clinical development / medical affairs to design non-interventional studies (NIS).

NIS consider a broad, heterogeneous and large patient population. Studies will not be blinded or randomized and performed for already approved drugs. So participants are patients who get actual treatment as prescribed by their doctors.

NIS pursue a broader objective than clinical trials:

  • The confirmation of efficacy of the drug in the setting of patients‘ everyday treatment
  • Quality of Life results for patients
  • Health Economic aspects (which are interesting for payers)
  • As well as the confirmation of drug safety and side effects

Sometimes pharma companies initiate NIS as a requirement by authorities during regulatory approval.

Especially for the developments in biosimilars, this seems to be an increasingly interesting topic. The “Generics and Biosimilars Initiative” has recently talked about the fact that some doctors do not always feel comfortable that the same clinical studies are used for an only similar compound, despite comparative studies.

Maybe that is one reason why companies with a biosimilar division take a closer look at the subject of NIS to collect more data in terms of efficacy? Naturally reimbursement and pricing also play their part.

In the EU so far 20 biosimilars have been launched and maintain same efficacy for a lower price.

We would be more than happy to find the right Consultant for you, who has the relevant Global Clinical Development Experience and excellent expertise for the development of a NIS in your therapeutic area.

Your next possible project is the design of a NIS?

Our consultant works autonomously to achieve your milestones of:

  • Conducting the necessary literature research
  • Seeking advice from an ethics committee
  • Choosing the right methodological approach
  • Developing the study concept and study protocol
  • Involving all relevant stakeholders
  • Incorporating national differences within a global study
  • Whatever else might be important to you!


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