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Define.xml is "arguably the most important part of the electronic dataset submission for regulatory review,” according to The FDA’s Technical Conformance Guide. It helps reviewers gain familiarity with study data, its origins and derivations, as well as sponsor-specific implementation of CDISC standards.

Webinar Video

With the latest Pinnacle 21 Enterprise 3.4 release, we continue to bring efficiencies to your data standardization and compliance efforts. This release features a number of new enhancements and compliance checks that you have been asking for. This release also marks the formal roll-out of our new customer-centric initiative and a dedicated Customer Success Team.

We recently hosted a webinar presenting the new features. You can watch the video, access the slides, review the Q&A, or read the summary below.

Webinar Video

Pinnacle 21 recently hosted a webinar discussing the FDA’s new business rules for clinical data. You can watch the video, access the slides and review the Q&A list.

Webinar Video

On November 2, Pinnacle 21 was the recipient of the 2016 TOPRA Award for Regulatory Excellence in Innovation. We were excited to be nominated and shortlisted among some incredible competition. We are really thrilled to accept the award this year!

VIDEO: Max Kanevsky's acceptance speech

December 17, 2016, is less than five months away.

As we all know by now, studies starting on or after that date must be submitted to the Food & Drug Administration electronically. They must also utilize the most-recent FDA-acknowledged version of data standards.

To support the latter point, FDA is requesting that sponsors submit a Study Data Standardization Plan (SDSP) as part of the IND application.

With time running out quickly, two big questions have taken on a new urgency:

In late 2014, the FDA announced that, starting December 17, 2016, all new clinical and nonclinical studies must be submitted electronically and contain data in conformance with the standards specified in FDA’s Data Catalog. This is part of an effort to accelerate the regulatory review process.

At the time of this writing, that deadline is only nine months away. So, the big question looms: Are you 100% ready for FDA submission? Because when December 17th comes, any doubt you have may represent a risk of slowing down the review process. More importantly, you’ll be missing out on an opportunity to get your new drug to market faster than ever before.

On November 24th, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) published its first official list of validation rules for CDISC SDTM, ADaM and Define.xml. These long awaited rules cover conformance, reviewability and quality requirements, as described in the PMDA Technical Conformance Guide on Electronic Study Data Submissions. The rules will ensure that data conform to the standards and support ease of use and meaningful analysis.

The PMDA agency 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 data guide. PMDA has introduced new “Reject” rules, which, if violated, will cause the review to be suspended until issues are corrected. PMDA can also suspend review if explanations for certain issues are not provided.

OpenCDISC has begun a rebranding process. The first step in that process, effective immediately, is that our organization will no longer be using the name “OpenCDISC” for any product, service or event.

Going forward, OpenCDISC Community will now be known as Pinnacle 21 Community; and OpenCDISC Enterprise will now be known as Pinnacle 21 Enterprise.

Why? After many years of mutual support and understanding, the CDISC organization has asked us to stop using the name “OpenCDISC.”

What does this mean to you? Ultimately, nothing. The staff at Pinnacle 21 will continue to develop our open source software and make it available to all, free of charge. And we will continue to help and support our users as we always have.

Pinnacle 21 is proud to announce the launch of OpenCDISC Enterprise 3.0, which will be available November 2, 2015. This enhanced, comprehensive, web-based application makes it easier than ever to manage standards compliance over the entire study life-cycle.

Now, instead of validating data right before regulatory submission (and unearthing a world of problems), you can manage it from the beginning: controlling your process, mitigating your risk, and reducing your time to market.

“Continuous Compliance” is Pinnacle 21’s proprietary approach for managing and ensuring consistent data from the moment you design the protocol all the way through to FDA and PMDA submission — and OpenCDISC Enterprise 3.0 is the tool that drives it. The result is an intelligent process that:

• Eliminates risk
• Saves time and money
• Achieves faster FDA approval

Pinnacle 21 is pleased to announce that we’ve been awarded a renewed contract to provide software and services in ongoing support of the FDA’s DataFit program.

According to the FDA’s Center for Drug Evaluation and Research (CDER), which made the decision: