MIAMI, June 14, 2016 /PRNewswire/ -- Biorasi, a CRO widely recognized for delivering success in complex clinical trials, today announced the successful upgrade of its Data Sciences and Biometrics capabilities under the leadership of Jon Roth. A CDISC-authorized Analysis Data Model (ADaM) trainer since 2008, Mr. Roth was responsible for the first FDA submission to include analysis data in the ADaM format and has considerable experience in large-scale study data integrations.
Biorasi's Data Sciences and Biometrics group collaborates to collect, clean, and analyze clinical data for sponsor's studies, either as part of a full service CRO project or as a stand-alone data services capability. In all cases, the group leverages the integration of industry-accepted Clinical Data Interchange Standards Consortium (CDISC) standards and cutting-edge technology platforms into a seamless, end-to-end process.
"While data management and biostatistics have always been a priority for Biorasi, the mission Jon Roth began when he joined us one year ago has culminated in this powerful upgrade of our Data Sciences and Biometrics services," stated Boris Reznik, Ph.D., Chairman, Biorasi. "All Biorasi data processes and structures are now built around CDISC data standards, empowering our project teams to leverage clinical data to guide the execution and quality assessment of a study."
As Vice President, Data Sciences and Biometrics, Mr. Roth possesses more than 25 years of practical experience working in the life science industry, having been involved with the early CDISC development of ADaM. This first-hand experience gives Biorasi's Data Sciences and Biometrics group a major advantage, as the current FDA Data Standards Catalog now specifies use of the CDISC SDTM, SEND, ADaM, and Define-XML standards as well as CDISC Controlled Terminology.
As a CDISC Certified Trainer and pubic speaker, Mr. Roth is also delivering advanced training to leading pharmaceutical and biotechnology companies, assisting them with technical and strategic initiatives to meet new regulatory requirements while improving their own business processes.
For more information on Biorasi's full service capabilities including an overview of the company's Data Sciences and Biometrics services, please visit: http://www.biorasi.com/what-we-do/data-sciences-and-biometrics.
Biorasi is a contract research organization (CRO) widely recognized for delivering success in complex clinical trials. This is possible through TALOS™, an innovative operating model that unifies systems and teams with a powerful project management methodology to ensure high quality delivery. Overall, Biorasi balances power, time, acceptance, cost and service level to optimize the delivery of clinical studies.
Global biopharmaceutical companies have come to depend on Biorasi to deliver their most complex studies. The company's expertise includes a range of molecule types, development phases, therapeutic areas, geographies, and development programs. Biorasi has collaborated with sponsors to enable FDA, EMA, and multi-venue approvals for numerous small molecules and biologics.
Biorasi, headquartered in Miami, Florida, maintains office-based teams around the globe. The company has received the coveted CRO Leadership Award from Life Science Leader magazine and has placed on the Inc. 500 list of America's fastest growing companies. For more information, visit www.biorasi.com.
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