Biometrics in clinical trials offers statistical and conceptual advice for scientists and physicians on study planning, support with funding applications,
development of study protocols and biometric analyses. Biometric counselling covers a wide range of different services, which we would be happy to discuss with you in detail.

We are happy to support you in the following areas in particular:

• 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.)
• Case number planning
• Study protocol development
• Review of eCRFs (electronic Case Report Forms)
• Randomisation service
• Statistical analysis and preparation of the statistical report
• Support with scientific publications (protocol; results) according to current methodological reporting standards

To register for biometric counselling at KKS Oldenburg, please contact:

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)