RESTON, Va.--(BUSINESS WIRE)--Aptiv Solutions, a global biopharmaceutical and medical device development services company and leader in adaptive clinical trials, announces the election of Vlad Dragalin, PhD, Senior Vice President of Software Development and Consulting, as a Fellow of the American Statistical Association (ASA), the world’s largest community of statisticians. A prestigious honor for over 95 years, Fellowship in the ASA recognizes outstanding professional contributions in the field of statistical science.
The ASA recognized Dr. Dragalin for excellence in statistical consulting in the pharmaceutical industry, for important contributions to the theory and methods for design and analysis of clinical trials including adaptive designs, dose-finding studies and sequential analysis, and for the advancement of software to enable innovative trial designs to be used in clinical development.
Dr. Dragalin holds a Master of Sciences in Applied Mathematics from Moldova State University and a PhD in Probability and Mathematical Statistics from Steklov Mathematical Institute in Moscow. He is a member of the Drug Information Association (DIA), the Society for Clinical Trials, the International Society for CNS Clinical Trials and Methodology, and an Associate Editor of Journal of Biopharmaceutical Statistics. He is involved in the PhRMA Working Group on Adaptive Designs and the PhRMA Working Group on Adaptive Dose Ranging Studies (currently under DIA) and is elected member of to the PhRMA Biostatistics and Data Management Technical Group.
Dr. Dragalin is the second member of Aptiv Solutions to become a Fellow of the American Statistical Association, joining Professor Andy Grieve, Senior Vice President, Clinical Trial Methodology. Both are members of the Aptiv Solutions Innovation Center, which plays a critical role in developing methodologies to support the design and execution of innovative adaptive trials. The group works with leading pharmaceutical and biotech companies, as well as regulatory authorities, to design, simulate, and execute traditional and adaptive clinical trials. They are currently working on the launch of a new version of Aptiv Solutions proprietary software ADDPLAN® for exploratory phase dose finding trials (ADDPLAN® DF).
About Aptiv Solutions
Aptiv Solutions is a global development services company that is focused on enhancing clinical trial decision-making, efficiency and productivity in the pharmaceutical, biotech and medical device markets. The company offers clients an extensive portfolio of innovative services including adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has more than 850 professionals in North America, Eastern & Western Europe, Israel, and Japan. Visit the website at www.aptivsolutions.com.
ADDPLAN® is the leading fully validated statistical design, simulation and analysis software for adaptive clinical trials and is widely used by regulatory agencies and the pharmaceutical and medical device industry. The products that are currently available include:
ADDPLAN® Base: Adaptive group sequential designs and sample size re-estimation
ADDPLAN® MC: Adaptive multiple comparison procedures
ADDPLAN® PE: Adaptive population enrichment
ADDPLAN® DF: Adaptive dose finding