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ZEG Berlin GmbH

Zentrum für Epidemiologie und Gesundheitsforschung

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Study Management

Our project managers are adept in making adjustments when needed

Our project managers have the skill and experience to make swift decisions and adjustments to study requirements as they unfold. All of our project managers have medical and / or epidemiological backgrounds with significant experience in the research and regulatory environments. In collaboration with you, we design, execute, evaluate the study, informing you along the way. We can support your work with comprehensive solutions as well as offering specific components:

  • Develop the study design and study materials (i.e. protocol, safety management plans, informed consent forms, study operation procedures and more)
  • Undertake large prospective cohort studies, case-control studies, drug efficacy studies, single-arm safety studies, drug utilization studies, and other types of non-interventional and interventional studies
  • Manage protocol approval with regulatory bodies, ethics boards, study participant recruitment, study participant follow-up and physician payments (if applicable)
  • Write interim reports, final study reports and peer-reviewed journal publications
  • Set up independent Safety Monitoring and Advisory Councils to ensure the transparent and rigorous scientific conduct of all studies
  • Deliver results on time and to budget

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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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Impressum

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