Mr. Guinter brings a wealth of industry experience to his new role. He previously worked as an independent consultant providing clinical data standards expertise to the industry's top clinical trial sponsors. In addition, he has held several leadership positions within sponsor and software vendor organizations, including GRMS Life Sciences, Take Solutions, Octagon Research Solutions and Sanofi.
Max Kanevsky, CEO, Pinnacle 21, commented, "Tom brings a unique combination of sponsor and vendor experience that is founded in a deep understanding of the use, best practices and benefits of implementing clinical data standards. His leadership experience and innovative approach to data standardization make him a great fit for the Pinnacle 21 team."
Tom Guinter, vice president, clinical data services, added, "I am really excited to join Pinnacle 21. Our team has developed the industry standard tool for validating and documenting CDISC clinical data for electronic regulatory submissions. The FDA and the PMDA are both using the tool. This positions us well to offer unprecedented, practice-based expertise to the market in the form of novel services that complement our suite of tools."
Mr. Guinter is located in Pinnacle 21's headquarters office in Plymouth Meeting, Pennsylvania.
About Pinnacle 21
Pinnacle 21 is the leading provider of clinical data standards software and subject matter expertise to the life sciences industry. The US FDA and Japanese PMDA leverage Pinnacle 21 Enterprise to validate and review clinical data submitted in electronic regulatory submissions according to the CDISC SDTM and ADaM standards. Learn more at www.pinnacle21.net.
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SOURCE Pinnacle 21