Blog

FDA Validation Rules webinar — recap

December 17, 2014

On November 19, 2014, the FDA’s Center for Drug Evaluation and Research (CDER) released its new “Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.’’ According to CDER, the organization is doing this “to improve the standardization and quality of [submitted] clinical data … as well as to improve the predictability of data quality and usefulness.”

But what does this mean for you? Fortunately, Pinnacle 21 recently hosted a webinar to answer this very question.

Introducing OpenCDISC Community 2.0

December 11, 2014

We are proud to announce the release of our next generation open source toolkit. Community 2.0 was created just for the CDISC professional and provides a wealth of game-changing new tools, including an upgraded version of Validator, a Define.xml Generator, and more. Download OpenCDISC Community 2.0 here

OpenCDISC Community 2.0 includes the following new features:

  • Validator – upgraded with FDA validation rules and ability to validate against study specific value level metadata
  • Define.xml Generator – creates fully compliant Define.xml 2.0 for SDTM, SEND, and ADaM datasets
  • Data Converter – quickly converts data between SAS XPORT, Dataset-XML, Excel, and CSV formats
  • ClinicalTrials.gov​ Miner – aggregates clinical outcome measures/endpoints across trials and therapeutic areas

FDA Publishes Official Validation Rules for Submission Data

November 18, 2014

This morning, November 18th, the Food and Drug Administration (FDA) published its first official list of validation rules for CDISC SDTM. These long awaited rules cover both conformance and quality requirements, as described in the FDA Study Data Technical Conformance Guide. Conformance validation rules help ensure that the data conform to the standards, while quality checks help ensure the data support meaningful analysis.

The FDA is asking sponsors to validate their study data before submission using these published validation rules and either correct any validation issues or explain, why they could not be corrected, in the Study Data Reviewer's Guide. This recommended pre-submission validation step is intended to minimize the presence of validation issues at the time of submission.

Rest assured: we have implemented the new FDA validation rules in the upcoming OpenCDISC Community 2.0 — keeping you ahead of the curve. Please join Sergiy Sirichenko — co-founder of OpenCDISC and an FDA Data Fitness Analyst — to learn about the new FDA validation rules and how you can get compliant in time for your next submission.

Open CDISC Live: San Fran — Recap

October 24, 2014

Sanfran

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.

Open CDISC Live: New Jersey — Recap

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.

OpenCDISC Live comes to San Francisco

September 10, 2014

OpenCDISC Live is making its way to the San Francisco Bay Area for the West Coast swing of our 2014 tour!
Enjoy this opportunity to meet the creators of OpenCDISC face-to-face, ask questions, collaborate and learn.

In our first West Coast Forum, we'll be discussing how to prepare for the new FDA JumpStart and DataFit processes.
We'll also give you an in-depth look at OpenCDISC Enterprise and show you how its new advancements can assist
the process.

Eventbrite - OpenCDISC Live San Francisco

Creating Define.xml 2.0 with OpenCDISC Webinar — Recap

August 27, 2014

The “Creating Define.xml 2.0 with OpenCDISC” webinars that ran on August 12th and 14th seemed to have served a big need. We had a total of 311 attendees across the two webinars, and received many thoughtful questions.

Bottom line: a lot of you have been struggling with Define.xml, and are excited to have a tool that can create FDA-compliant Define.xml 2.0 files so quickly and assuredly. But, as with any new technological solution, there is a learning process involved.

OpenCDISC Live comes to New Jersey

August 6, 2014

OpenCDISC Live is making its way to North Jersey for the second stop on our 2014 tour! Enjoy this opportunity
to meet the developers of OpenCDISC face-to-face, ask questions, collaborate and learn.

In our second Forum, we'll be discussing how to prepare for the new FDA JumpStart and DataFit processes. We'll also give you an in-depth look at OpenCDISC Enterprise and show you how its new advancements can assist the process.

Eventbrite - OpenCDISC Live New Jersey