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.

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.

Running data validations for PMDA has required a separate compliance strategy, plus extra time for validation and regulatory submission. Too often, sponsors worry that PMDA submission packages will fall short of reviewer expectations.

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.

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

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?

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

The next meeting of the NJ CDISC User Group will be held on Monday, Feb 27, 2017, 1-5pm at Novartis Pharmaceuticals Corporation, East Hanover campus.
 
If you are interested in attending this meeting (in-person or online), please register by Friday, Feb 10th.

Register for NJ CDISC User Group
 
Planned agenda:

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

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.

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: