Studies under »real-world« conditions

Non-interventional studies are gaining growing importance due to current EU legislation on pharmacovigilance.

In collaboration with SocraMetrics as biometrical CRO, a complete package of services is offered including all relevant project steps from conception and study protocol creation including the selection of study centres to the conduct and professional management of the clinical part and to clinical data management, statistical evaluation and reporting. Of course, all governmental notification and approval procedures are also part of our full service as are the preparation and support of Scientific Advice meetings with the authorities if intended.

Our NIS portfolio

Non-interventional studies include a number of different study types, with specific focus on the following:

  • Post-Authorisation Safety Studies (PASS)
  • Post-Authorisation Efficacy Studies (PAES)
  • Drug Utilisation Studies (DUS)
  • Other non-interventional observational studies

Clinical experience

We generally offer and recommend a very thorough feasibility assessment to make sure that there is a good chance of recruitment success.

  • Bronchial diseases including COPD and asthma
  • Diabetes mellitus
  • Hypertension
  • Disorders of lipid metabolism
  • Oncology including antibody therapy
  • Pain (acute and chronic)
  • Urology
  • Gynaecology
  • Gastrointestinal diseases
  • Allergies of the airways (allergic rhinitis, hay fever)

Interested?

Then contact us to find out more.

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