January 27, 2017

The next meeting of the NJ CDISC User Group will be held on Monday, Feb 27, 2017, 1-5pm at Novartis Pharmaceuticals Corporation, East Hanover campus.
If you are interested in attending this meeting (in-person or online), please register by Friday, Feb 10th.

Register for NJ CDISC User Group
Planned agenda:

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June 4, 2015


The 2015 PharmaSUG Annual Conference, in Orlando, Florida, was an important and telling event. Pinnacle 21 was there, as both a presenter and exhibitor. The event drew more than 600 attendees, who generated a wealth of intriguing questions and discussions over the four-day stretch.

If you attended our programs, or witnessed the buzz of activity around the booths, then you saw what we saw: pharmaceutical software users who were eager to learn more about how to navigate FDA regulatory submissions in the months and years to come.

Pinnacle 21 ran two important programs to try to answer some of our attendees’ biggest concerns:

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October 24, 2014


On October 9, 2014, the Pinnacle 21 tour bus rolled over the Golden Gate Bridge and into Foster City, where we held our third OpenCDISC Live event. And what an event it was.

We kicked off with a brief history of OpenCDISC, where Max Kanevsky, Pinnacle 21 president and CEO, talked about the origins of the project and how it has evolved over years. Attendees then received tutorials on two FDA programs — JumpStart and DataFit — and learned why both are so critical to the modern FDA review process.

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September 15, 2014

Team Pinnacle 21
Team P21 (L to R): Piotr Romanowski, Sergiy Sirichenko, Inna Lernerman, Max Kanevsky, Gerard McDevitt, Kevin McIntyre, Travis Collopy

The second stop on the OpenCDISC Live 2014 Tour, in East Hanover, NJ, was a lively and engaging event, and we thank everyone who attended.

In addition to providing tutorials on two FDA programs — JumpStart and DataFit — our subject matter experts covered how to create FDA-compliant Define.xml 2.0 files. Attendees also got a sneak peek of OpenCDISC Community v2.0, the next-generation of our gold-standard open-source software.

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September 8, 2014


OpenCDISC Live is making its way to North Jersey for the second stop on
our 2014 tour!

Our first OpenCDISC Live event — in Boston, earlier this summer — drew more than 100 attendees, and a wealth of thoughtful discussions around JumpStart, DataFit, and the modern FDA approval process.

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June 16, 2014

OpenCDISC Live Team

Thanks to all who attended the first OpenCDISC Live Forum in Boston, MA!

This inaugural CDISC and FDA educational event was a resounding success. Topics covered included the challenges and opportunities presented by JumpStart, DataFit, and the modern FDA approval process.

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May 15, 2014

OpenCDISC-live.jpgPinnacle 21 proudly introduces OpenCDISC Live!

This series of events will travel across the U.S., throughout 2014 and beyond. They will provide time and space for pharmaceutical and biotech professionals to meet with the developers of OpenCDISC, learn what’s coming from the FDA and CDISC, ask questions, collaborate and learn.

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