Solutions
Our research is built on a foundation of scientific rigor and transparency, generating evidence that supports sound decision-making across regulatory, clinical, and legal contexts. With dedicated expertise in women’s health and hormonal medicine, our conclusions are shaped by our in-house specialists and refined in collaboration with external scientists. We offer a broad range of solutions for both late-stage and post-approval phases, drawing on diverse data sources that reflect the real-world health experiences of women across all life stages, as outlined in our case studies below.
Pre-Approval/ Approval
Primary Data Collection (Prospective/Direct)
- Phase IIIB Safety
- Phase III Efficacy & Safety
- Disease Registries
- Pragmatic Studies
Secondary Data Sources (Retrospective/Existing)
- Epidemiology & Burden of Disease
- Target Patient Population Characteristics
- Target Patient Sample Size Analysis & Forecasting
- Cost of Illness & Healthcare Resource Use
- Treatment Patterns & Patient Journey Analysis
- Feasibility & Data Strategy
- Evidence Gap Analysis & Lifecycle Planning
Post- Approval
Primary Data Collection (Prospective/Direct)
- PASS/PAES
- Product Registries
- Hybrid Decentralized Studies
- Physician / Patient Surveys (cross-sectional studies)
Secondary Data Sources (Retrospective/Existing)
- Comparative Effectiveness
- Safety & Drug Utilisation Monitoring
- Treatment Adherence, Persistence & Switch Assessment
- Real-World Outcomes & Costs
- Long-Term Outcomes & Patient Segmentation
- Guideline Adherence & Care Gaps
- Medical Communication & Evidence Sharing
Strategic consulting services
ZEG Berlin provides the expert guidance to manage complex research while meeting the highest scientific and regulatory standards.
- Planning and conduct of a non-interventional study (NIS)
- Specialized support for PRAC/EMA submissions and regulatory alignment
- Tailored study protocol development
- High-level scientific advisory
- Statistical analysis
- Professional medical writing, and publication support
Rating scales for researchers
Between 1999-2005 an interdisciplinary team of clinicians, epidemiologists, and psychologists developed four patient-reported outcomes tools that explored the effect of sex hormones on health and aging. As part of ZEG Berlin’s commitment to improving the transparency and quality of epidemiological research, the scales are provided here for researchers to use in their work. All rating scales are based on the Health-Related Quality of Life (HRQoL) concept and assess specific health concerns that can be difficult to derive from other sources.
Researchers interested in applying the scales in their research can contact us to clarify their purpose and the licensing fees behind them. We support academic and research use without licensing. As soon as you plan to commercialize our products or are interested in implementing them in clinical trials, a licensing fee has to be paid to the copyright holder. For any publication, we would kindly ask you to refer to the applicable original literature and use an acknowledgement within the publication for the copyright holder.
Any new information or developments concerning the scales will be made publicly available.
Background information on the scales’ development, reliability, and validity can be found on the individual scale pages.
All surveys have been validated and are available in several languages.
- Menopause Rating Scale
- Aging Male Symptoms Scale
- Scale for Quality of Sexual Function
- Short Term Hormone Effect Scale
Educational Workshops
Our specialized workshops provide deep-dive expertise into the unique lifecycle of Non-Interventional Studies. We equip teams with the practical and theoretical knowledge required to execute high-quality NIS.
- Planning & Operational Management: Best practices for navigating the specific logistical challenges of non-interventional research.
- Regulatory Frameworks: Comprehensive guidance on current requirements, recommendations, and evolving legal landscapes.
- Statistical Methodology: Tailored approaches to statistical analysis specific to observational and real-world data.
- Quality Management: Establishing robust documentation standards to ensure data integrity.
- Safety & Compliance: Pharmacovigilance responsibilities within the NIS context.
Publications