NIS: Pharmaceutical Products


Non-interventional study – what is that? A short introduction

Non-interventional study (NIS) is a controversial issue with considerable qualitative differences. In spite of this fact, this term perfectly describes what it is actually about:

Observation and documentation of the treatment with a usually relatively new drug under every-day practical conditions with a patient population which usually exceeds in number the corresponding “artificial” collectives in clinical trials.

High-quality non-interventional study can help to generate new important insights about application, effectiveness and safety of the respective drug. However, the proofs of effectiveness or superiority of one therapy over the other cannot be usually obtained by means of NIS.


Important questions in the planning phase

We deal with customers who are well-experienced in the conducting of NIS as well as with those who have never conducted such a study. Nevertheless, the initial questions on the project concern both groups:

  • What questions should be answered by means of the planned NIS?
  • Is actually NIS an appropriate instrument for that?
  • Should NIS be conducted online or offline?
  • Should ethics committee be involved?
  • What fees are acceptable for investigator´s documentation efforts?
  • What authorities and institutions are to be informed?
  • What are the study-related costs?
  • What should be taken into consideration while conducting NIS in foreign European countries?
  • Is it possible to conduct NIS, for instance, with pharmacists etc.


Our service

Our expertise definitely gives you maximum support while answering these questions. Certainly a lot of questions also comprise some coarse points (e.g. online vs. offline: the greater the number of cases and the higher the data quality requirements, the clearer the benefits of the online projects)

In any case, every project is unique and we always treat it as such.

With our scope of service we tried to present all necessary steps in the framework of NIS. The service modules can be used in any combination: sometimes we conduct all of these modules, but usually our customers prefer to conduct some parts of NIS themselves.

NEW:

mediV docnet

More doctors – one documentation: with mediV docnet Mediveritas develops the innovative Software for the networks of doctors as an external and internal proof of the treatment quality.

Read more here.