Biometrics in Clinical Trials offers statistical and methodological advice to researchers and clinicians on trial design, support with grant applications,
the development of trial protocols, and biometric analyses. Our biometric consultancy covers a wide range of services, which we would be happy to discuss with you in detail.

We are particularly happy to assist you with the following areas:

• Selection of the study design and selection of suitable primary and secondary endpoints
• Application procedures for public funding and foundations (BMFTR, DFG, G-BA, etc.)
• Sample size planning
• Development of the protocol
• Review of eCRFs (electronic Case Report Forms)
• Randomisation service
• Statistical analysis and preparation of the statistical report
• Support with scientific publications (protocol; results) in accordance with current methodological reporting standards

A service centre has been set up in the Department of Epidemiology and Biometry in co-operation with the KKS to provide biometric advice on proposals and the planning of clinical studies.

Area of responsibility

1. Clinical trials
   • Medicinal Products Act / Clinical Trials Regulation (AMG / CTR)
   • Medical Device Law Implementation Act (MPDG)

   • Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

2. Other studies
   • in accordance with the Professional Code of Conduct of the Lower Saxony Medical Association (BO ÄKN), where a sponsor is formally required due to the specifications of an external funding organisation (e.g. DFG, BMFTR)