SEND

How We Improved the SEND Validation Rules

June 11, 2020

When preparing data for regulatory submissions, we know you need to comply with hundreds of validation rules. While many rules are straightforward, some could be confusing. Are you wondering why a certain validation rule fired? If it’s applicable to your study? And whether you should fix it or explain it? These and other commonly asked questions were answered by Pinnacle 21’s Michael Beers in a recently hosted webinar. You can watch the recording below. For webinar slides and frequently asked questions, read on.

Define’s New Stylesheet

August 22, 2019

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. In addition to the define.xml, the Technical Conformance Guide also asks that sponsors submit a stylesheet. A stylesheet transforms the define.xml into a human readable structure.

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