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.

Validate SDTM Medical Devices data

Pinnacle 21 has expanded support to medical device companies. Now you can validate your study data and metadata against the SDTM Medical Devices Implementation Guide v1.0. The Medical Devices standard is an extension SDTM-IG v3.2 and includes seven new domains and additional device-specific variables.

Browse Validation Rules

The Validation Rules Browser is back on the Pinnacle 21 website. Now it features an intuitive search, which lets you quickly locate any rule-related information you need. Just enter a relevant term, to search the available rules for any and all CDISC standards, and to see what’s required by FDA or PMDA. It’s as easy as “Googling it”!

Validate Custom Standards & Terminology (Enterprise only)

It’s too late and costly to catch errors in submission data. You need to start by validating your company standards and study specifications. Now you can upload them using our system, and know immediately which ones are compliant (and, which ones need work). By validating at the standards level, you’ll begin every study knowing you’re working with clean, compliant metadata — which helps you avoid the difficulties and the lost time.

Track Changes in Standards & Terminology (Enterprise only)

Each time CDISC updates its standards and terminology, our new tool will show you what’s changed and how your custom metadata needs to be adjusted for compliance. You can track the most recent updates to CDISC standards and terminology against older versions … and, you can also track different versions of your own standards — eliminating the time and frustration that comes with doing it manually.

Create Reviewer’s Guides to Expedite Review (Enterprise only)

A well-crafted Reviewer’s Guide mitigates confusion, thereby expediting the review process. Now you can automate and simplify the process of creating Reviewer’s Guides for clinical and pre-clinical tabulation data, as well as analysis data. Our tool generates compliant templates, pre-populates critical sections for you, and helps explain a submission’s data issues — saving you both aggravation and valuable time.

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These advancements were created to support the next evolution of review: Continuous Compliance. It’s Pinnacle 21’s proprietary approach for managing and ensuring consistent data from the moment you design the protocol all the way through to FDA submission. Rather than validating data right before regulatory submission — and unearthing a world of problems — you can now manage it from the beginning: controlling your process, mitigating your risk, and reducing your time to market.

If you have any immediate questions about the platform updates, the FDA deadline, or Continuous Compliance, please email us.