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ZEG Berlin GmbH

Zentrum für Epidemiologie und Gesundheitsforschung

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Quality Assurance

Unified in our mission for independent studies to monitor benefits and risks

ZEG Berlin was invited by the European Medicines Agency to be a founding partner of ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance). ENCePP’s aim is to strengthen monitoring of the benefit-risk balance of medicinal products in Europe. It does so by facilitating the delivery of high quality, independent, post-authorisation studies and developing and maintaining methodological standards and governance principles in research. ENCePP’s mission is ZEG Berlin’s mission. Since joining ENCePP, ZEG Berlin has complied strictly with the ENCePP Code of Conduct, with all eligible studies being awarded the ENCePP seal.

ZEG Berlin maintains its own Standard Operating Procedures (SOPs) to govern critical aspects of our daily work. SOPs are reviewed regularly and updated as needed. We also create study-specific working procedures outlining study conduct for all project, data and event validation staff.

All documents and procedures take account of the relevant rules, laws, regulations and quality assurance measures, including:

  • Complying with the respective relevant good practice guidelines, such as Good Pharmacoepidemiology Practice (GPP), Good Epidemiology Practice (GEP), Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP)
  • ENCePP Code of Conduct
  • Conducting regular site audits during study conduct
  • Undertaking regular internal quality audits
  • Attending regular in-services and training opportunities to stay abreast of changes in the quality assurance environment

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Services

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

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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
  • Diagnostic tools
  • Data collection instruments

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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