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 2008, 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 Community. For our full suite of FDA and CDISC compliance software products, please see below.
This suite of open-source tools includes an upgraded version of the game-changing Validator — along with Define.xml Generator, a Data Converter, and more — to make compliance easily manageable for the entire biopharmaceutical industry.
Used by FDA to review submission data, Enterprise is the next evolution of CDISC compliance software. This comprehensive solution does everything — from validating data to creating Define.xml — to support your end-to-end lifecycle.
Maybe you need more than the basic software, but your compliance budget is limited. Our On-Demand option delivers. You get our enterprise-level solution — with next-level reports and services — but pay only for what you need.
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Even if you have the best software, you don’t always have the time. Pinnacle 21’s staff works with the FDA to help implement its Enterprise solution and review submissions. And we can help you, as well, in a variety of ways.
FDA Submission Readiness
Our experts will ensure that your study data and documentation are compliant with FDA’s requirements, and ready to support the regulatory review process — giving you the best chance at a successful, and timely, review.
Define.xml files are sighted by the FDA as the most common to be invalid and needing remediation. At Pinnacle 21, we have the expertise, and the software, to create valid quality Define.xml files based on your requirements.
A well-constructed Study Data Reviewer’s Guide (SDRG) can be the key to helping reviewers understand a submission’s contents, ensuring a smooth review. But who has the time and resources to create one? The experts at Pinnacle 21 do.
CROs often struggle to provide data that meets CDISC standards or other sponsor specifications. Pinnacle 21 will help you configure OpenCDISC with custom rules, to ensure that your CROs deliver on your expectations.
Give a man a fish and he eats for a day. Train a person to understand validation rules, and to know when and why and how to fix them, and you’ll have a professional who can ensure quality data for years. Let us teach your people what we know.
Trying to navigate CDISC’s suite of global standards can feel like a dizzying maze. Fortunately, our experts can provide any consultation you need — from general guidance to specific data quality fixes. No one knows CDISC like Pinnacle 21.
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
Download & Install
Reports in Excel & CSV
Rule & Spec Designer