Max Kanevsky and the Pinnacle 21 team, known for their Pinnacle 21 Enterprise software used by FDA, PMDA and clinical trial sponsors to validate and document CDISC clinical data for electronic regulatory submissions, were nominated, shortlisted and won the award in the Innovation category. This category honors outstanding achievements in the deployment and successful implementation of innovative ideas while recognizing individuals or organizations that truly embrace enhancements to the regulatory profession.
Max Kanevsky, CEO of Pinnacle 21, commented, "We are extremely honored to accept this prestigious award. Pinnacle 21 Enterprise, the validation tool used by FDA and PMDA, delivers confidence to sponsors preparing and submitting CDISC compliant data packages as well as the regulatory authorities receiving them. Our team continues to collaborate with regulatory authorities and sponsors around the world to produce innovative solutions that streamline data compliance processes and this award is a tribute to that entire body of work."
The TOPRA Awards for Excellence in Regulatory Affairs were established in 2010 to reward excellence, wherever it may occur in regulatory affairs and recognize the achievement of individuals, teams and organizations both within TOPRA and in the wider regulatory affairs community. Winners were announced at a gala event on November 2, 2016 in London.
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, SEND and ADaM standards. Learn more at www.pinnacle21.net.