WASHINGTON, Oct. 20, 2022 /PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance and Japan Distribution Logistics (DMAH) support is pleased to announce the formation and expansion of its biostatistical division, led by former FDA biostatistician Alvin Cutler Van Orden. To support the company's growing role in providing biostatistical consulting services across all therapies, MCRA has hired Mr. Van Orden as its Vice President of Biostatistics, supplementing MCRA's leadership in providing integrated global support to the medical device industry.

Mr. Van Orden joined MCRA from the US Food and Drug Administration (FDA), where he spent over 15 years with the Center for Devices and Radiological Health, most recently as a Mathematical Statistician. Mr. Van Orden brings extensive experience to the role, including in-depth biostatistical reviews of medical device submissions for orthopedic, aesthetic, neurological, respiratory, and general surgery devices. Prior to joining MCRA, Mr. Van Orden worked at the FDA where he wrote statistical reviews of marketing submissions and provided feedback to medical device companies. Mr. Van Orden has a substantial background in utilizing an array of statistical tools and methods and has been involved at every stage of the FDA review process, from the planning stages to the analysis of clinical data and the design of post-market studies.

At MCRA, Mr. Van Orden provides expert consultation regarding biostatistics and leads clinical and statistical strategies for all submissions involving clinical data. The biostatistics division will also provide input into study protocols and design, develop, and review statistical analysis plans for a variety of medical devices and biologic products. Mr. Van Orden will also utilize his expertise to advise, provide guidance, and to oversee the quality control of statistical deliverables and outputs to our clients and FDA.

David Lown, MCRA's President said, "MCRA continues to lead the industry in providing top level talent with the goal to introduce innovation to patients worldwide. Alvin Van Orden is a prime example of an industry leader that will work closely with the MCRA clinical, regulatory, and reimbursement teams, improving our integrated business model and taking on the challenges of the technology lifecycle as we become more interwoven and multifaceted. We are honored Alvin has joined MCRA. He will make a tremendous impact."

Glenn Stiegman, Senior Vice President of Clinical and Regulatory Affairs said, "As MCRA's success continues, we wanted to expand our biostatistics capabilities and we wanted someone with the necessary leadership and expertise. Mr. Van Orden provides that leadership and experience. Mr. Van Orden's extensive time at the FDA has provided him with a deep understanding of what the FDA will expect in a clinical study analysis, but also how to position it for success. This experience will be extremely valuable for MCRA's clients that need guidance and support throughout the lifecycle of their products."

Mr. Van Orden said, "I loved my time at the FDA, and I see my work at MCRA as an extension of that role: to help life-improving medical devices get to market. I am excited be part of this smart, experienced, talented team, and I believe MCRA adds immeasurable value to all phases of product development."

MCRA is proud to continue supporting innovation in the medical device industry by helping clients navigate the biostatistical requirements globally.

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 clients industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, 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, 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, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. 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

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SOURCE MCRA, LLC