Contract Research Organization in Berlin: ZEG Berlin for Real-World Evidence

ZEG Berlin GmbH is a Contract Research Organization based in Berlin. The company specializes in Real-World Evidence (RWE), pharmacoepidemiology, and non-interventional research. Since its formal establishment in 1990 – with scientific roots reaching back to the 1960s – ZEG Berlin has been planning and conducting studies for companies in the pharmaceutical and healthcare sectors as well as for scientific and regulatory clients.
The company’s guiding principle is: We deliver evidence. To achieve this, ZEG Berlin combines epidemiological and medical expertise with study design, strategic consulting, operational execution, biostatistics, medical writing, and scientific communication. The focus is on generating robust evidence on safety, effectiveness, use, and healthcare delivery under real-world conditions.

What is a Contract Research Organization?
A Contract Research Organization, or CRO, provides scientific, methodological, and operational support for research projects. This support can begin with the development of a research question and extend through study protocol development, study and data management, and statistical analysis to regulatory documentation and publication.
In epidemiological studies, medical, statistical, and operational requirements need to be aligned at an early stage. Study design, endpoints, data source, population, and analysis strategy form an integrated methodological process. Careful planning provides the basis for ensuring that the data collected or analyzed can answer the defined research question.
Within the CRO market, ZEG Berlin has a clear scientific focus on pharmacoepidemiology, Real-World Evidence, as well as late-phase and post-authorization research. The company has particular experience in hormonal health and women’s health.

Real-World Evidence Under Real-World Healthcare Conditions
Real-World Evidence complements findings from controlled clinical trials with data from actual use and routine healthcare. Randomized studies investigate clearly defined research questions under specified conditions. Due to their inclusion and exclusion criteria, however, they do not always reflect the full diversity of the population that will later receive treatment.
Real-world studies can, for example, examine which patient groups receive a therapy, how medicines are used in routine practice, and which safety, effectiveness, or healthcare outcomes can be observed. Data sources may include prospective observational studies, registries, physician and patient surveys, as well as suitable secondary data sources.
ZEG Berlin follows its own principles of Good Evidence Practice. These principles structure the research process from the formulation of the research question and selection of the data source through analysis, reporting, and scientific communication.

ZEG Berlin Services
The range of services covers research projects before, during, and after market authorization. The specific methods and services are tailored to the scientific research question, the product lifecycle, and the available data.

Pre-Approval and Approval
In the phases before and around approval, ZEG Berlin supports both the prospective collection of new data and the retrospective analysis of existing data sources.
Primary data collection includes:
• Phase IIIB safety studies
• Phase III efficacy and safety studies
• Disease registries
• Pragmatic studies

Prospective studies enable targeted data collection for a defined research question. The study protocol specifies, among other aspects, the population, endpoints, data collection methods, and analytical procedures. In addition to the scientific objectives, planning also takes practical feasibility, realistic recruitment assumptions, and the required data quality into account.

For the analysis of existing data, ZEG Berlin offers services including:
• Epidemiology and disease burden
• Target population characterization
• Sample size analysis and forecasting
• Disease costs and healthcare resource utilization
• Treatment patterns and patient journeys
• Feasibility assessment and data strategy
• Evidence gap analysis and lifecycle planning

Secondary data analyses can provide a structured overview of the available evidence even in early development phases. They can support the assessment of target populations, treatment pathways, disease burden, and available endpoints.
An evidence gap analysis identifies which scientific questions can already be answered using existing data and where additional evidence is required. Based on this, a research strategy can be developed that is aligned with the respective stage of the product lifecycle.

Post-Approval
Following approval, ZEG Berlin supports the further investigation of safety, effectiveness, use, and healthcare outcomes under real-world conditions.
Primary data collection includes:
• Post-Authorization Safety Studies (PASS)
• Post-Authorization Efficacy Studies (PAES)
• Product registries
• Hybrid and decentralized studies
• Physician and patient surveys
• Cross-sectional studies

PASS investigate defined safety questions after a medicinal product has been authorized. They may be conducted voluntarily or as part of regulatory requirements. PAES are used to further investigate aspects of effectiveness.
ZEG Berlin supports the design and conduct of such studies as well as the preparation of scientific and statistical documentation. Research questions, data quality, analytical methods, and reporting are methodologically aligned.

Product registries enable systematic observation over longer periods. They can provide data on use, safety, effectiveness, and long-term outcomes. Hybrid and decentralized study designs complement traditional site-based elements with digital or location-independent methods of data collection.
In the field of secondary data, ZEG Berlin analyzes topics including:
• Comparative effectiveness
• Safety and drug utilization
• Adherence and persistence
• Product and therapy switching
• Real-world outcomes and healthcare costs
• Long-term outcomes
• Patient segmentation
• Guideline adherence and gaps in care

Comparative effectiveness analyses examine different treatment approaches under real-world healthcare conditions. Analyses of drug utilization, adherence, and persistence show how therapies are used and continued in routine practice. Patient segmentation identifies groups with different characteristics, treatment patterns, or outcomes.

Strategic Consulting, Biostatistics, and Medical Writing
In addition to study planning and conduct, ZEG Berlin advises clients on research projects with complex scientific and regulatory requirements.
Services include:
• Planning of non-interventional studies
• Support with PRAC and EMA submissions
• Regulatory coordination for real-world studies
• Development of customized study protocols
• Scientific and methodological consulting
• Biostatistics and statistical analysis
• Statistical analysis plans
• Medical writing
• Publication support

Strategic consulting begins as early as possible in the research process. Before a protocol is finalized, the research question, population, study design, endpoints, data source, and analysis strategy should be assessed together.
The statistical analysis plan is derived from the research question and study design. Depending on the data and the study, methods for addressing confounding, missing data, selection mechanisms, and sensitivity analyses may be required.
Medical writing ensures clear and audience-appropriate documentation. Study protocols, reports, regulatory documents, and scientific manuscripts are subject to different formal requirements. Early alignment supports a consistent presentation of methodology, analysis, and results.

Educational Workshops
ZEG Berlin offers educational workshops on the lifecycle of non-interventional studies and real-world research. The workshops are designed for professional teams seeking to expand their methodological and practical expertise.
Possible topics include:
• Planning of non-interventional studies
• Operational study management
• Regulatory requirements
• Statistical methods
• Quality management
• Pharmacovigilance and compliance
• Scientific reporting

The content can be tailored to the requirements of a team or project. A shared methodological understanding supports collaboration between Medical Affairs, Pharmacovigilance, Epidemiology, Biostatistics, and Regulatory Affairs.

Rating Scales and the EURAS/INAS Study Design
ZEG Berlin’s proprietary scientific tools include several patient-reported outcome instruments and the EURAS/INAS study design.
Between 1999 and 2005, an interdisciplinary team developed four scales:
• Menopause Rating Scale (MRS)
• Aging Male Symptoms Scale (AMS)
• Scale for Quality of Sexual Function (QSF)
• Short Term Hormone Effect Scale (SHE)

The instruments are based on the concept of health-related quality of life. They capture symptoms, functional limitations, and other effects from the patient perspective. The scales have been validated and translated into multiple languages.
For certain academic and non-commercial research purposes, use without a license fee may be possible. Separate licensing conditions apply to commercial applications and clinical studies.
The EURAS/INAS design stands for European Active Surveillance and International Active Surveillance. It was developed in the late 1990s and has been used in Post-Authorization Safety Studies since 2000.
The approach combines direct surveys of study participants with medical validation of relevant events. The surveys can capture information that may not be fully available in routine data or passive reporting systems. Medical validation supplements these data with documentation and professional assessment.

Experience and Scientific Network
ZEG Berlin’s scientific roots date back to the 1960s. In 1990, the Center for Epidemiology and Health Research was established as an independent organization.
Epidemiology remains the methodological foundation of the company. Over several decades, ZEG Berlin has gained experience with prospective studies, secondary data analyses, registries, surveys, and long-term safety monitoring.
ZEG Berlin was invited to become a founding partner of ENCePP. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance promotes scientific standards, transparency, and methodological quality. According to the company, all eligible ZEG Berlin studies have received the ENCePP Seal.
As a CDISC-aligned Organization, ZEG Berlin follows internationally established standards for data structures and study documentation. More than 200 scientific publications document study results and methodological contributions from several decades of research.

ZEG Berlin in Berlin
ZEG Berlin is headquartered at Invalidenstraße 115, 10115 Berlin. From there, the company coordinates research projects with an international reach.
Study activities extend across Europe, North and South America, the Asia-Pacific region, and other regions. ZEG Berlin therefore combines a permanent base in Berlin with internationally oriented study processes.

Frequently Asked Questions About ZEG Berlin
What types of studies does ZEG Berlin conduct?
The range of services includes Phase IIIB and Phase III studies, disease and product registries, pragmatic studies, PASS, PAES, hybrid and decentralized studies, as well as physician and patient surveys. ZEG Berlin also analyzes existing data sources.

Does ZEG Berlin support study planning?
Yes. ZEG Berlin supports the development of research questions, study protocols, endpoints, data strategies, and statistical analysis plans. Additional services include feasibility analyses, regulatory coordination, medical writing, and publication support.

Does ZEG Berlin work with primary and secondary data?
ZEG Berlin prospectively collects data in purpose-designed studies and analyzes existing secondary data sources. The choice depends on the research question and the suitability of the available data.

Does ZEG Berlin offer statistical analyses?
Biostatistics and statistical analysis are part of the service portfolio. This includes sample size analyses, statistical analysis plans, data analyses, and documentation of results.

How can I contact ZEG Berlin?
The team can be reached by phone at +49 30 945 101-20 or by email at info@zeg-berlin.de.

Contact ZEG Berlin
ZEG Berlin supports clients in the planning, conduct, analysis, and communication of non-interventional and pharmacoepidemiological studies.
ZEG Berlin GmbH
Invalidenstraße 115
10115 Berlin

Phone: +49 30 945 101-20
Email: info@zeg-berlin.de