WASHINGTON, February 22nd, 2024/PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm 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.
Dr. Chava Zibman states, “I am excited to join MCRA and bring my extensive statistical expertise to clients around the world. I am eager to help MCRA grow as the preferred consulting firm for companies seeking statistical assistance for their diagnostic devices.”
Glenn Stiegman, Senior Vice President, Clinical & Regulatory Affairs, states, “As MCRA continues to grow, our biostatistics capabilities are expanding to match our service and therapy areas. Dr. Chava Zibman’s wealth of experience and knowledge are invaluable for MCRA's diagnostics clients that need guidance and statistical support during their clinical evaluation of their products.”
Anthony Viscogliosi, CEO of MCRA, states “MCRA continues to lead the industry in providing top level talent with the goal to introduce innovation to patients worldwide. Dr. Chava Zibman is a prime example of an industry leader who will work closely with the MCRA clinical, regulatory, and reimbursement teams, through improving the delivery of value by taking on the challenges of the technology lifecycle and creating opportunity for our clients. We are honored to have Dr. Zibman join MCRA.”
About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client’s industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com
For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: ahoward@mcra.com