Chava Zibman, Ph.D.

Overview

Dr. Zibman brings biostatistical expertise to MCRA where she is responsible for clinical trial design, data analysis, and regulatory strategy as regards to the use of statistical methods in the evaluation of diagnostic devices in particular those relating to in vitro diagnostics, radiology, and digital health. She develops and reviews statistical analysis plans prior to clinical studies and is responsible for describing statistical methods and study results following study completion.

Walter Lindstrom, J.D.

Overview

At MCRA, Walter builds on the decades of experience he has provided clients with critical Patient Access Program services – ranging from benefits verifications to prior authorizations and appeals – which are often necessary to ensure patients benefit from the transformative healthcare technologies that are needed to meet the demand for value-based care models.

AI & Imaging Center

Over the past 10 years, innovation in AI imaging software has exploded, with over 600 cleared FDA submissions. MCRA is at the cusp of this exciting change in healthcare. MCRA’s deep therapy specialization and heritage of clinical and regulatory leadership is best positioned to offer these key services as this exciting time period unfolds.

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