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:

The first, “The Most Common Issues in Submission Data,” covered the data quality issues most frequently seen by our experts. Now that FDA has announced that future submissions will be required in standardized format, many are struggling to navigate the data issues inherent in that process. We showed attendees how to avoid some common errors across many regulatory submissions, and provided recommendations on how they can ensure the highest quality submission data.

The second, “OpenCDISC Community Toolset 2.0 for Clinical Programmers,” was a workshop that provided an overview of installation, tuning, usage and automation of various OpenCDISC Community applications — including Validator, Define.xml Generator, Data Converter and ClinicalTrials.gov Miner. Clinical programmers who work with CDISC standards got to know the “ins” and “outs” of this open-source toolkit on another level … and the positive response from the crowd was palpable.

Below, you’ll find links to the various decks Pinnacle 21 presented at PharmaSUG 2015. We hope you find them informative and helpful. If you have any specific questions pertaining to submission data issues and how they can affect the FDA approval process, please send us an email.

Conference PowerPoint Slides:

• The Most Common Issues in Submission Data
• OpenCDISC Community 2.0 Toolset for Clinical Programmers
• Creating Define.xml with OpenCDISC Community 2.0