Blog

New Pinnacle 21 Enterprise 4.0 Eases Concern about PMDA Submissions

April 2, 2019

Released March 31, the new P21 Enterprise 4.0 provides more options for submitting study data to the Japanese health authority PMDA, plus better ways to manage validation issues and reports, as well as new validation rules and support for STDMIG 3.3.

The new software release is the topic of our April 18, 2019, live webinar “Introducing P21 Enterprise 4.0”, featuring Pinnacle 21 President & CEO Max Kanevsky and Product Manager, Amy Garrett.

Please register for one of the two 45-minute sessions, either 9:00 am or 2:00 pm eastern time.

P21 Enterprise 4.0 addresses concerns raised by our customers who submit data to both FDA and PMDA. Historically, regulators at the two agencies have embraced clinical data standards and conformance rules at different rates and degrees of severity.

SDTMIG 3.3 – What’s New?

December 12, 2018

Now that the long-awaited SDTMIG 3.3 has been officially released, Pinnacle 21 team has eagerly began to implement validation rules for this new standard. As the first step, we performed a gap analysis for changes since SDTMIG 3.2. We excited to share our findings with the CDISC community, which you can find in the slides along with summary of changes below.

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The Do's and Don'ts of Define.xml

December 10, 2018

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

FDA Validator Rules 1.3 Released

November 12, 2018

Last week, FDA published an updated version of Validator Rules for study data. There are many changes which we have reviewed and summarized for you.

The first change you’ll notice is that there are a number of new columns:

  • FDA Validator Rule ID – a unique rule id that is now consistent across FDA, PMDA, and Pinnacle 21
  • FDA Validator Message – validation messages produced by the Validator
  • Publisher – the source of the business or conformance rule, FDA or CDISC

The FDA list now includes the conformance rules published by CDISC, which is the why the list has grown by 317 rules, from 163 to 480. The CDISC rule ids can be found in the Publisher ID column.

Next, the FDA added a reference to SEND-IG 3.1 to show how existing business and conformance rules apply to this standard. CDISC is still working on the conformance rules for SEND-IG 3.0 and 3.1, so this list could serve as a guide for implementers for the time being.

So how does this release effect you?

What’s New in Enterprise 3.4

May 17, 2018

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 Announces Platform Updates - Fall 2016

September 27, 2016

With the December 17th deadline drawing near, we are happy to announce several important and timely updates to our platform.

The FDA mandate goes into effect in only 80 days, at which point all new submissions will be required in standardized, electronic format. These new Pinnacle 21 tools will help you meet those demands quickly and confidently.

What’s new:

Validate Analysis Results Metadata (ARM)

Analysis Results Metadata provides traceability from results in a statistical display to the data in the analysis datasets. It helps regulatory reviewers understand and reproduce analysis results, which is why both FDA and PMDA are interested in ARM being included in Define.xml. Now you can ensure that your ARM metadata is compliant and ready for submission.

How to Prepare a Study Data Standardization Plan (SDSP) for FDA

July 25, 2016

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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: