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ZEG Berlin GmbH

Zentrum für Epidemiologie und Gesundheitsforschung

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Non-interventional study design

Raw data collected under real-life conditions deliver robust results.

Non-interventional studies (NIS) or observational studies are important in the development cycle of pharmaceutical products. NIS observe prescribing and drug utilization patterns under real-life conditions giving insight into drug effectiveness and safety during routine use.

ZEG Berlin specializes in the design and conduct of primary-data driven, non-interventional studies. The most scientifically robust data, delivering the most accurate results, comes when you have full oversight of the collection and management of raw data directly from the prescription source. Our international network of field organizations is highly experienced in implementing patient-reported outcome studies. Under our stewardship, our network recruits patients reflective of real users in order to deliver results that target your individual needs.

There is little homogeneity in the regulation, documentation, and processes which can make research daunting. The regulatory bodies across geographies vary, and the landscape is in flux with regulations introduced or revised frequently. ZEG Berlin is experienced in navigating the NIS regulatory environment and ethical submissions and guides you at every step.

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Expertise

  • Non-interventional study design
  • Post-authorization safety studies
  • Post-authorization efficacy studies
  • Cohort studies
  • Case-control studies
  • Medical Devices
  • Patient Reported Outcomes (PROs)
    • Aging Male Symptoms Scale
    • Menopause Rating Scale
    • Scale for Quality of Sexual Function
    • Short Term Hormone Effect Scale
    • Research team
  • Data collection instruments

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ZEG Berlin

Berlin Center for Epidemiology and Health Research

Invalidenstraße 115
10115 Berlin
Germany

Contact Us

Expertise

  • Real-World Evidence
  • Non-interventional study design
  • Post-authorization safety studies
  • Post-authorization efficacy studies
  • Cohort studies
  • Case-control studies
  • Medical Devices
  • Patient Reported Outcomes (PROs)
  • Data collection instruments

Services

  • Crisis Management
  • Consulting
  • Data Management and Biostatistics
  • Medical Writing
  • Study Management
  • Quality Assurance
  • Pharmacovigilance

ENCePP

We are a partner centre of the ENCePP scientific network which is coordinated by the European Medicines Agency. We are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological Standards and promoting scientific independence and transparency. We register studies in the ENCePP E-Register of Studies, a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies.

General Data Protection Regulation

With a view to the introduction of the GDPR/EUDSGVO we are glad to present our newupdated privacy policy . The updated description are stored under “about us” and then “privacy policy/GDPR”. Further translation for study participants will follow contemporary.

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