You’ve probably heard of JumpStart by now. The FDA is describing it as a “service [that] is modernizing the drug review process.” But how, and why? And how can the pharmaceutical and biotech industries benefit from it?

One of the big drivers of this change was time. Currently, when the FDA receives a submission, reviewers spend up to 45 days just to assess the quality of that submission. They have to first churn through enormous files — some of which are gigabytes in size — to determine if the data quality and content are strong enough to support the review. Between the time spent by the FDA to conduct this “pre-review,” and the time spent by the submitting organization to fix these issues and resubmit, valuable months are often wasted.

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.

Pinnacle 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.

Welcome to the first ever OpenCDISC Live Forum - a series of events where you can meet the developers of
OpenCDISC face-to-face, ask questions, collaborate and learn.

In our first 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 Validator 1.5 and show you how it's new advancements
can assist the process.

We're pleased to announce the availability of OpenCDISC Validator 1.5.
Download OpenCDISC Validator 1.5 here

What’s New in Version 1.5

• Validation against SDTM 1.4 model and SDTMIG v3.2
• Validation of Define-XML v2.0
• Support for Dataset-XML format
• Updated SEND config for FDA compliance
• Various bug fixes and minor engine enhancements. Please refer to the changelog for details.
• Various updates to SDTM 3.1.3, 3.1.2, 3.1.1, and SEND 3.0 configs. For a complete list of validation rule changes please refer to the release notes.

Registration is open for the next meeting, scheduled for April 17, 2014 from 1-5pm. The meeting will be hosted by Celgene at their Summit site. Web conferencing will also be available. Please register by Wednesday, April 9. The link to register: https://www.survey-expert.com/surveyIndex.asp?U=8000008002105027347

Meeting agenda:

• Lex Jansen and Marcelina Hungria:  Dataset-XML - A New Exchange Format for Clinical Research Data
• Greg Steffens:  SUPPQUALs
• Kevin Lee: CDISC Journey on Lymphoma Studies using Cheson 2007
• Joyce Hernandez:  CDISC Pharmacogenomics/Genetics Standard 
• Karin LaPann:  Challenges of Processing Questionnaire Data from Collection to SDTM to ADaM and Solutions using SAS®

See you there!

The next meeting of the NJ CDISC Users Group will be held the afternoon of April 17, 2014 at Celgene in Summit. If you are interested in presenting at the meeting, please contact Patricia Majcher at patricia.majcher@novartis.com by March 7. Presentations should be no more than 20 minutes long (excluding time for Q&A). Any CDISC-related topic is welcome. We look forward to hearing from you!

Registration is now open for the January 14, 2014 meeting. The meeting will be held from 1-5pm at Sanofi, 55 Corporate Drive (Room B-1121), Bridgewater, NJ. Web conferencing will also be available. Please register by Monday, January 6. The link to register: https://www.survey-expert.com/surveyIndex.asp?U=1009002005108017393

Meeting agenda:

• Jeff Xia (Galderma): Demo of how to check hyperlinks in define.xml and corresponding CRF Page number in blankcrf
• Jian Chen; Peter Smilansky (Edetek): End-to-End Study Management using BRIDG
• Nate Freimark (Theorem Clinical): Approaches to Creating ADaM Subject-Level Analysis Datasets (ADSL) for Integrated Analyses
• Kevin Lee (Cytel): CDISC Journey to solid tumor using RECIST 1.1
• Greg Steffens (Novartis): Data and metadata related to SUPP data sets

See you there!

The next meeting of the NJ CDISC Users Group will be held the afternoon of January 14, 2014 at Sanofi in Bridgewater, NJ. If you are interested in presenting at the meeting, please contact Pei Lee Tien by November 8. Her email address is pei.tien@novartis.com. Presentations should be no more than 20 minutes long (excluding time for Q&A). Any CDISC-related topic is welcome. We look forward to hearing from you!

We're pleased to announce the availability of OpenCDISC Validator 1.4.1.
Download OpenCDISC Validator 1.4.1 here

What’s New in Version 1.4.1

• Support for latest ADaM v1.2 Validation Checks
• Validation of QS Controlled Terminology
• Enhanced Excel report with the versions of Validator, MedDRA, and CDISC CT
• Refined SDTM, SEND, and ADaM rule messages and descriptions
• Various bug fixes and minor enhancements. Please refer to the changelog for details.

For a complete list of validation rule changes please refer to the release notes or review the latest rules posted on OpenCDISC Validation Rules Repository.