HTA Statistics and Outcomes Research for Successful Market Access

Successful market access for a new medicinal product depends heavily on the quality and validity of the evidence presented. In addition to clinical studies, secondary data analyses and real-world data (RWD) provide valuable evidence. With BioStats GmbH, you can generate robust results that meet the requirements of health technology assessments (HTA) and benefit assessments, serving as a basis for reimbursement decisions.

Secondary data analyses of clinical studies enable systematic evaluation of existing data to answer new research questions. Supplementary real-world data analyses provide insights into treatment effectiveness and safety under everyday conditions. This allows you to demonstrate the clinical value of your product beyond controlled study settings in a transparent and reproducible way.

Alongside standardized methods, BioStats GmbH also offers individually tailored analyses to address the specific requirements of your project. Such approaches allow complex questions to be tackled and the evidence base strengthened. Examples include survival analyses for adverse events with varying follow-up times (SAVVY), or advanced methods to improve the evaluation of adverse events.

We also conduct indirect, adjusted treatment comparisons, enabling evaluation of therapeutic alternatives even without direct head-to-head studies. Network meta-analyses systematically and robustly link various studies to generate comprehensive evidence. (Figure 1).

BioStats GmbH supports you in creating solid evidence for HTA dossiers, benefit assessments, and reimbursement negotiations – ensuring the scientific and regulatory strength of your submissions.