Pinnacle 21 is the industry leader in software and services for managing CDISC compliance, clinical data quality, and FDA submission readiness. Pinnacle 21 is a Platinum Member of CDISC, as well as a CDISC technology partner. Since 2011, Pinnacle 21 has worked with the FDA to implement a go-to platform for standards compliance and data-quality evaluation of electronic submission data.
In 2011, Max Kanevsky created and launched OpenCDISC Validator: an open-source tool for ensuring SDTM and ADaM compliance. It has since become the most widely used validation software in the biopharmaceutical industry. Following its success, Max and his partners formed Pinnacle 21 — to create new, game-changing innovations, including Enterprise-wide FDA compliance software and services.
Pinnacle 21’s founders have worked with the FDA for years and have an unparalleled understanding of the submissions process, regulatory guidelines related to electronic data submission, requirements for clinical datasets, Define.xml, and supporting documents such as the Study Data Reviewer Guide. And our consultants are experts in managing compliance across SDTM, SEND, ADaM, Define.xml, and therapeutic area standards.
So now you know a little more about Pinnacle 21. Few people know our name, but everybody knows our flagship solution: OpenCDISC Validator. For our full suite of FDA compliance products and services, please see below.
Validator is the industry gold standard for FDA compliance. Open source, easy to use, and commercial quality, Validator ensures clinical data compliance with CDISC standards, including SDTM, ADaM, SEND, Define.xml, and more.
Used by the FDA itself to review submission data, Enterprise is the next evolution of CDISC compliance software and support. This comprehensive data-quality and compliance solution supports and enables your full data life cycle.
Maybe you only have a few studies, a short project, or you're not ready to commit to Enterprise. Our On-Demand option delivers. You get our enterprise-level solution — with next-level reports and services — but pay only for what you need.
FDA regulations are constantly changing. At Pinnacle 21, our data fitness analysts are always up to speed on the latest compliance standards and regulations. We’ll review and analyze your data to ensure it’s ready for FDA submission.
WHY PINNACLE 21
To say that a lot rides on the quality of your data would be a gross understatement. It needs to be right. Needs to be. Unfortunately, the variables that impact regulatory compliance are always changing. And adhering to CDISC standards, while navigating the FDA’s modern review process, is a challenge that can keep you up at night. Fortunately, Pinnacle 21 has the solutions, knowledge, and experience to give you the best possible chance of achieving FDA approval.
Used by FDA
A Step Ahead
REVIEW AND ANALYZE YOUR DATA WITH
THE SAME TOOLS USED BY THE FDA
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ENTERPRISE IS THE NEXT EVOLUTION OF CDISC COMPLIANCE SOFTWARE AND SUPPORT
This web-based application — used by the FDA itself to review submission data — requires no installation, and provides updated standards in real time. Security is enabled through stringent access controls, 256-bit encryption, and ISO 27001 certified data centers. And Enterprise is fully compliant with the requirements and guidance of FDA’s 21 CFR Part 11 and General Principles of Software Validation. Enterprise also offers some of the most forward-thinking features available.
Download & Install
Reports in Excel & CSV
Rule & Spec Designer
Pinnacle 21 also offers premier-level consulting services. If your submission is time-critical, and/or you need an expert hand to help you navigate through the choppy regulatory waters toward FDA approval, please give us a call.