BioStats GmbH as Your Partner for DiGA Studies

BioStats supports you from study planning to statistical reporting – with experience from numerous BfArM consultations and successfully approved applications.
To ensure that your digital health application (DiGA) can be included in the BfArM directory, its efficacy must be scientifically demonstrated. BioStats GmbH guides you through the entire process, from endpoint definition to statistical analysis, always in line with BfArM’s methodological requirements.
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Our Experience in DiGA Studies

Die BioStats GmbH unterstützt Sie bei Erfüllung dieser Anforderungen und der damit zusammenhängenden Planung, Durchführung und Auswertung Ihrer klinischen Studie. Damit begleiten wir Sie zuverlässig auf dem Weg zur Aufnahme Ihrer DiGA ins Verzeichnis. Dabei profitieren Sie von unserer langjährigen Erfahrung und unserer Teilnahme an zahlreichen Beratungsgesprächen mit dem BfArM, in denen wir tiefe Einblicke in die Anforderungen gewinnen konnten.

We offer comprehensive expertise in:

• Study Planning: Development of a methodologically sound study design in line with BfArM requirements.
• Endpoints & Evidence: Support in defining clinically relevant endpoints and demonstrating the effectiveness of your DiGA.
• Minimal Important Difference (MCID): Ensuring results are not only statistically significant but also clinically meaningful.
• Sample Size Calculation: Determining the necessary number of participants to ensure robust and reliable outcomes.
• Statistical Methods: Application of advanced statistical techniques, including handling missing data and complex endpoints.
• Result Reporting: Preparation of results in tables, figures, and listings (TFLs), providing clear interpretation for regulators and stakeholders.

Our Services for Your DiGA Study

• Study protocol • Statistical analysis plan (SAP) • Randomization lists • Data management
• Data evaluation • Statistical report • Study documentation • Evaluation report according to §137e SGB V
We have already supported several digital health application providers that have been successfully listed and bring expertise in the following areas:
• Mental and behavioral disorders • Endocrine, nutritional, and metabolic diseases • Diseases of the circulatory system
• Skin and eye diseases • Respiratory diseases • Nervous system diseases

Why BioStats

• Experience with BfArM consultations and deep understanding of regulatory requirements
• Combination of scientific methodology and practical experience
• Proven track record: multiple digital health applications successfully included in the DiGA directory
Your Contact at BioStats
Contact us for a non-binding conversation with Dr. Alexander Krannich personally.
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