Plymouth Meeting’s Pinnacle 21, which provides clinical data standards software and subject matter expertise to the life sciences industry, has won this year’s TOPRA Award for Regulatory Excellence in Innovation.

Max Kanevsky and the Pinnacle 21 team won the award for their Pinnacle 21 Enterprise software which is used by the FDA, PMDA, and clinical trial sponsors to validate and document CDISC clinical data for electronic regulatory submissions. The winners for 2016 were announced at a gala event in London on earlier this month.

Established six years ago, the TOPRA Awards for Excellence in Regulatory Affairs reward excellence in regulatory affairs and recognize the achievement of individuals, teams, and organizations.

The innovation category honors outstanding achievements in the field of deployment and successful implementation of innovative ideas while at the same time recognizing individuals or organizations which truly embrace enhancements to the regulatory profession.

“We are extremely honored to accept this prestigious award,” Said Pinnacle 21 CEO, Max Kanevsky. “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.”