Clinical Biostatistics Services | ACOMED statistik
Transforming complex biological data into robust, submission-ready evidence requires more than just statistical software—it requires deep methodological expertise and a proactive partner.
ACOMED statistik is an independent, Germany-based biometrics consulting firm serving the global life science industry, with a strong footprint in the US market. Since 2003, we have been supporting pharmaceutical sponsors, Contract Research Organizations (CROs), medical device and IvD manufacturers in designing, analyzing, and reporting clinical trials. We bridge the gap between complex statistical methodology and clear, executive-ready decision-making.
Biostatistics for IVD Analytical & Clinical Performance
The regulatory landscape for In Vitro Diagnostics (IVDR, FDA) requires robust statistical evidence. As active contributors to international CLSI subcommittees and IFCC working group, we bring firsthand knowledge of current regulatory expectations to your analytical performance studies diagnostic studies. We provide expert statistical design and analysis for both analytical performance validation and clinical performance.
Biostatistics Consulting and Subcontracting for CROs
When your internal biometrics team is at capacity or facing highly specialized statistical challenges, we seamlessly integrate into your workflow. As a reliable subcontractor, we provide protocol design, Statistical Analysis Plan (SAP) writing, and SAS® programming. We act as a proactive extension of your team, ensuring fair, transparent pricing without unexpected change orders.
Dedicated Support for US-Based Life Science Companies
We successfully serve clients across the United States, providing high-end European methodological expertise combined with a highly collaborative approach. We are fully accustomed to working across time zones, offering seamless communication, proactive scoping to prevent change orders, and data-driven insights tailored for your management team and FDA submissions.
Biostatistics for Medical Device Clinical Investigations
Medical device trials demand a fundamentally different statistical approach than pharmaceutical studies. We assist manufacturers of all risk classes in planning and analyzing clinical investigations for CE marking (MDR) and FDA approval. From sample size calculations to defining appropriate endpoints and final statistical reporting, we ensure your data meets rigorous regulatory standards.
Independent Statistician for DSMB & Interim Analyses
Protecting patient safety and trial integrity is paramount. Regulatory bodies require a strict separation of roles when handling unblinded data. ACOMED statistik provides highly specialized services as the independent, unblinded statistician for Data Safety Monitoring Boards (DSMB) and Data Monitoring Committees (DMC). We translate complex interim data into clear decision templates for efficacy and futility analyses.
Biostatistics Support for Small and Midsize Pharma Companies
Small and midsize pharmaceutical companies often need expert statistical support without the overhead of a full internal biometrics department. We provide flexible, senior-level biostatistics support for study design, SAPs, analyses, reporting, and collaborative scoping when specifications are still evolving.
Learn more about our Biostatistics Support for Small and Midsize Pharma Companies
