MCRA, LLC

803 7th Street Northwest
Washington,  DC  20001

United States
http://www.mcra.com
  • Booth: 4658

MCRA is the leading therapy focused CRO and integrated advisory firm and the pioneer in integrating core services to advance innovation from inception to commercialization to support the Biotech and MedTech industries. Our global footprint with leadership across the top 3 healthcare markets: US, Europe, and Japan, integrated services expertise, and deep therapeutic knowledge make us the leading partner to bring medical innovation to markets around the world. Learn more at mcra.com.


 Press Releases

  • MCRA is pleased to announce the hiring of FDA Mathematical Statistician for Diagnostic Devices, Chava Zibman, Ph.D., as Principal Statistician, Diagnostics at MCRA.

    Dr. Zibman brings over fifteen years of statistical experience and over ten years of direct FDA experience to the position, working in the Center for Devices and Radiological Health (CDRH). Her experience as the FDA’s expert for in-vitro diagnostics makes her an accomplished expert in this field. She was awarded the FDA Commissioner’s Special Citation (2019) as a member of the Artificial Intelligence (AI) Review Team for “accelerating and promoting consistent regulatory decisions for radiological Computer Aided Decision-Making Software.”

    At MCRA, Dr. Zibman expands the team’s biostatistical expertise for its client base, including in-vitro diagnostics, radiology, AI and digital health. She will support clients in developing and reviewing statistical analysis plans and in implementing statistical analysis and interpreting study results following study completion. She will assist clients in responding to requests from regulatory agencies and will serve on Data Safety Monitoring Boards.

 Additional Info

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