SaMD Approved by the FDA for the Treatment of ADHD
Germantown, MD, USA (June 24, 2020) – Amarex Clinical Research, LLC, announces that its client has received U.S. Food and Drug Administration (FDA) approval for a software as medical device (SaMD) for the treatment of ADHD. Amarex provided statistical analysis services to its client for this product.
Dr. Kazem Kazempour, President & CEO of Amarex stated, “This was a unique project to work on and our Biostatistics team is thrilled to have participated in the development of this SaMD. The methods of statistical analysis applied for this trial were modeled after other standard randomized controlled pharmaceutical trials, and the product was approved through the FDA’s de novo pathway.”
Amarex has extensive knowledge of the digital therapeutic product approval process and has worked on many de novo applications. Our leadership team frequently conducts presentations on the topic of Artificial Intelligence (AI) and Software as Medical Device (SaMD).
About Amarex Clinical Research, LLC, an NSF International company
Amarex Clinical Research, LLC, an NSF International company, is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research. Their combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides services in Project Management: Phase I-IV, BE/BA, PK/PD; Regulatory Affairs: FDA Applications and meetings, applications to International Health Authorities, GxP Compliance Audits; Clinical Operations; Adaptive Study Designs; Statistical Analysis; Data Management; Medical Monitoring; Safety and Pharmacovigilance; and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information visit www.amarexus.com.
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