NIS

Experience in the implementation of NIS

with more than 30,000 patients in total.

Whether it is a full service or only certain services, PHARMALOG has a lot of experience in the implementation of non-interventional studies (NIS). Thanks to short channels and internal data management, even large amounts of data can be entered and analysed quickly. We create a suitable study design according to your project requirements.

We support all kinds of NIS

  • AWB
  • Cohort studies
  • Register studies
  • PASS
  • PAES

Services

  • NIS design – choice of a suitable design according to the aims of the project
  • Pharmacoeconomic planning and implementing the studies: Cost/benefit analysis, quality of life.
  • Testing the feasibility of the planned NIS
  • Developing the observation plan / documentation forms
  • Implementing the NIS according to BfArM, VfA and GEP requirements
  • Logistics
  • Collecting the contracts and returning the documentation forms
  • Contracts with investigators
  • Status reports
  • Close contact with those responsible for the project at the sponsor's end, e.g. the sales division
  • Quality assurance
  • Payment management