Statistically sound.

Market Access

  • Strategic consulting in the preparation of German benefit dossiers (acc. AMNOG)

  • Strategic planning of the 'story line' for the derivation of additional benefit in the whole process (advice meeting, dossier, written statement, oral hearing and price negotiations)
  • Advice with respect to the composition and the content of the benefit dossier and the written statement.
  • Advice with respect to further analyses beyond the results of the study reports. Analyses for special populations
    • Subgroup analyses
    • Sensitivity analyses
    • Metaanalyses
    • Network metaanalyses
    • Indirect treatment comparisons
  • Assessment of existing indirect treatment comparisons, metaanalyses and network metaanalyses with respect to suitability for the use in the benefit derivation.
  • Participation in oral hearings.
  • Support and advice in the compilation of written statements concerning assessments of competitive products in the context of benefit dossiers.
  • Training with respect to statistical aspects in the AMNOG process and the compilation of the dossier.


  • Module 4 of the dossier for early benefit assessment (§35a SGB V)
  • Preparation of statistical analysis plans for additional analyses.
  • Full analysis of all endpoints and subgroups with respect to dossier requirements, delivery of tables for Module 4 in German language and appropriate format to be copied directly in Module 4
  • Realisation of metaanalyses, indirect treatment comparisons and network metaanalyses.
  • Review of external statistical analyses.
  • Compilation of the methods section for the assessment of the validity of the evidence as well as the information synthesis and analysis.
  • Compilation of the results section for the medical benefit and additional benefit for the selected endpoints (chapter 4.3).
  • Compilation of the chapter concerning the potential for bias in the main text and in appendix 4F of modul 4.
  • Compilation of the chapter concerning the concluding assessment of the additional benefit (chapter 4.4).
  • Compilation of the methods of the included studies (appendix 4E).
  • Review and quality assurance of externally prepared chapters in module 4.