About Zurich Biostatistics

Zurich Biostatistics, Inc. (ZBI) has been a CDISC Registered Solution Provider since 2002. ZBI was invited by CDISC to join the very first group of CDISC Registered Solution Providers.

ZBI is an acknowledged leader in regulatory submission, technology, and training solutions. ZBI solutions are based on industry standards for clinical data and analysis. ZBI’s Michael Palmer helped to write the standards. Michael, ZBI President and co-founder, continues his active participation on CDISC and HL7 standards-writing teams. ZBI clients rely on insights that only active and ongoing participation in those teams can provide.

Recent successes include:

• Cost-effective, customized CDISC training for pharmaceutical, biotech, and vendor companies
• Comprehensive biostatistics support for a major pharmaceutical company's FDA advisory committee hearing
• Expert advice, business analysis, and software development regarding a CDISC software tool, for a European-based pharmaceutical company
• Creation of a clinical trials biostatistical design tool to accommodate pharmacogenomic information for a U.S. government agency
• Expert assessment of the impact of CDISC on regulated safety reporting and development of a standards-based SAS and XML solution for a U.S. government research enterprise
• Clinical-evidence-based Monte Carlo validation of a CDISC database for one of the world’s largest information technology companies
• CDISC XML-based automation of a clinical data submission, for a major Asian pharmaceutical company
• Orphan drug clinical study design and analysis for a niche biotech company
• Co-sponsored (with CDISC) training in regulatory submissions of clinical data.

ZBI is located in Morristown, New Jersey, within the “pharmaceutical corridor” and convenient to metropolitan New York City’s road, rail, and air transportation links.