Overview

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.

History

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.

Expertise

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.

WHEREVER I’VE SEEN STRUGGLES WITH DATA QUALITY OR COMPLIANCE, I’VE IMAGINED NEW SOLUTIONS THAT COULD HELP PEOPLE.

Max Kanevsky
Founder & CEO

I READ BIOSTATISTICS AND CLINICAL DATA LIKE A NATIVE LANGUAGE. I’M CURRENTLY WORKING WITH THE FDA TO HELP THEM DO LIKEWISE.

Sergiy Sirichenko
Data Scientist

I LEVERAGE MY EXPERTISE TO LEAD THE DESIGN AND DEVELOPMENT OF NEW, GAME-CHANGING COMPLIANCE TECHNOLOGIES.

Tim Stone
Chief Technology Officer

BUILDING SEMANTIC MODELS IS MY SINGULAR FOCUS. I BRING THAT FOCUS, ALONG WITH MY RICH EXPERTISE, TO THE TABLE EVERY DAY.

Michael DiGiantomasso
Semantic Modeler

You’ve met our people. Now check out our forward-thinking solutions.

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.

OpenCDISC Validator

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.

OpenCDISC Enterprise

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.

OpenCDISC On-Demand

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.

OpenCDISC Consulting

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

We offer the same products used by the FDA -- so you know you’re analyzing and preparing your data the right way.

CDISC Knowledge

We know CDISC standards like the back of our hand. It’s that expertise that enabled us to create OpenCDISC Validator.

A Step Ahead

We are always the first to implement new FDA rules and regulations, so you always remain a step ahead of the changes.

Unmatched Expertise

We have the unmatched insight and expertise to guide you through every regulatory and compliance barrier.


REVIEW AND ANALYZE YOUR DATA WITH
THE SAME TOOLS USED BY THE FDA

OpenCDISC Enterprise
OpenCDISC Enterprise screenshot
OpenCDISC Enterprise screenshot
OpenCDISC Enterprise screenshot

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.

OpenCDISC Enterprise Validation Scorecard

Validation Scorecard

Know precisely what to address by viewing a list of Pass/Fail grades on your data quality, standards compliance, etc.

OpenCDISC Enterprise Issue Organization

Issue Organization

View, organize, and tag various data issues through our intuitive interface. Also, add comments and assign tasks in a snap.

OpenCDISC Enterprise Issue Management

Issue Management

Communicate and collaborate with CROs, developers, and others to resolve timely issues through our simple messaging tool.

OpenCDISC Enterprise Change Tracking

Change Tracking

Produce and review a simple report that details only what has changed since the last time you validated your data.

OpenCDISC Enterprise Validation History

Validation History

In a single click, create a chart that shows the quality of your data over time, to ensure you’re moving in the right direction.

OpenCDISC Enterprise Define.xml Viewer

Define.xml Viewer

See, at a glance, if your metadata is written according to CDISC specifications, and get alerted to any marked issues.

OpenCDISC Enterprise Customizing Domains

Customizing Domains

Easily customize your data sets to support near-CDISC standards — like SDTM+ — or sponsor defined formats.

OpenCDISC Enterprise Updating Rules

Updating Rules

Update rules through our easy-to-use GUI to meet your specific requirements, and share them enterprise-wide.

No matter what your needs and budget, Pinnacle 21 has a solution to help you. Scroll down now to browse our offerings by features and price.
OpenCDISC Validator $0

Open Source

Desktop Client

Download & Install

XML Configuration

Reports in Excel & CSV

Community Support

OpenCDISC Validator $47K starting

RECOMMENDED

Issue Management

Change Tracking

Validation Scorecards

Rule & Spec Designer

Enhanced Reports

Dedicated Hosting

Priority Support

OpenCDISC Validator $299/study /month

Issue Management

Change Tracking

Validation Scorecards

Enhanced Reports

Multi-tenant Hosting

Professional Support


OpenCDISC Consulting

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.