Real-world evidence

Focusing on daily treatment patterns

Both in Germany and internationally, the use of real-world evidence (RWE) as a basis for decisions in the healthcare sector is being discussed. That discussion focuses on the need to capture and reflect the everyday healthcare environment in studies, because results from clinical regulatory studies—which follow an experimental and controlled design—only allow limited conclusions on day-to-day healthcare issues. For example, the assessment of the efficacy of a therapy under everyday conditions is a central topic.

When designing RWE studies, stringent requirements are necessary for the selection of databases, as well as the study design.

  • With your input, we develop suitable study designs to evaluate pharmaceuticals, medical devices and healthcare service programs based on the individual strategic goals and requirements.
  • Depending on the data base chosen, we support you in analyzing GKV routine data of the statutory health insurance companies in Germany as well as in the prospective collection of suitable primary data.
  • We ensure a scientifically sound approach to your individual research question. In addition to the appropriate statistical evaluation, this also includes the publication of the results in scientific journals or at conferences or according to special reporting standards, e.g. the Standardized Report Routine for Secondary Data Analysis (STROSA).

Real-world evidence solutions

Evaluating healthcare settings and integrated care concepts

Conducting economic analyses of daily treatment patterns 

Health data collection from primary sources

Collecting data in daily practice

Health insurance claims data analyses

Understanding routine data from daily clinical practice

Panels and surveys

Collecting and validating data from experts

Quality of life and preference studies

Understanding the value to patients

Set-up of Phase IV studies and registries

We are a full-service provider for NIS and registries, especially in context of G-BA requirements on benefit assessments of orphan drug registries

Sebastian Braun

Meet our expert

Dr. Sebastian Braun, Real-World Evidence 

Sebastian Braun