Define.xml Frequently Asked Questions
Discover answers to common Define.xml FAQs, covering best practices, expert tips, and essential guidance for…
CertaraDecember 10, 2018
What’s New in Enterprise 3.4 Q&A
Is there documented guidance on the creation of the sponsor SDTM metadata to be uploaded…
CertaraMay 17, 2018
Pinnacle 21 Wins TOPRA Award for Regulatory Excellence in Innovation
Certara’s Pinnacle 21 is honored to announce that Max Kanevsky, has been named to the…
CertaraDecember 1, 2016
How to Prepare a Study Data Standardization Plan (SDSP) for FDA
Get up-to-speed on Study Data Standardization Plan (SDSP) for FDA submissions. Read the blog post…
CertaraJuly 25, 2016
Introducing OpenCDISC Enterprise 3.0
Pinnacle 21 is proud to announce the launch of OpenCDISC Enterprise 3.0, which will be…
CertaraOctober 27, 2015
Max Kanevsky named to the PharmaVOICE 100 List of the Most Inspiring People
Certara’s Pinnacle 21 is honored to announce that Max Kanevsky, has been named to the…
CertaraAugust 5, 2015
FDA DataFit: an introduction
Explore FDA DataFit, a project ensuring high-quality, compliant data to streamline drug reviews, reduce delays,…
CertaraAugust 19, 2014
FDA JumpStart: an introduction
Discover FDA JumpStart, a ground-breaking service accelerating drug reviews by enhancing data quality, identifying risks,…
CertaraJuly 16, 2014
