Blog

In December 2022, the Food and Drug Administration (FDA) published an updated version of its Validator Rules. Pinnacle 21 Principal Consultant Michael Beers delivered an overview of the differences between newly released version 1.6 and the now legacy March 2021 version 1.5.

P21 is proud to announce that support for CDISC Open Rules Engine (CORE) is now available in P21 Community 4.0. We have expanded CORE’s reference implementation to let you execute machine-readable CDISC Conformance Rules within the familiar P21 toolkit. This new CDISC Engine can run from the desktop GUI or command-line interface (CLI) on any platform in which you have already installed P21 Community.

As of April 25, 2022, we have released P21 Community 4.0 to general availability! Install it now from our Downloads page.

P21C 4.0 is the first major release of this application since P21's M&A with Certara in October 2021, per the commitment that P21's software applications will “continue to be supported, updated, and developed.”

On December 15th, 2021, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) published its long-awaited update to the validation rules for SDTM, ADAM and Define.xml. PMDA Validation Rules 3.0 introduce additional standard conformance rules from CDISC, support for ADaM-IG 1.1, and many other changes.

At Pinnacle 21, we've got you covered. We have released support for these new rules in our latest validation engine PMDA 2010.2. And in this webinar, we've shared everything you need to know about PMDA Validation Rules 3.0.

On November 29th, CDISC released updated versions of SDTM and ADaM, including standardized structures for medical devices and new non-compartmental analysis data.

Moving to new versions of standards is always a challenge and requires planning. Pinnacle 21's subject matter experts Trevor Mankus and Michael Beers summarized key changes and answered industry questions in this webinar and the discussion below, so you can better prepare to up-version your study data.

New PMDA Engine

Pinnacle 21 is happy to announce the latest Validation Engine for submissions to Japan's PMDA! 🇯🇵

P21 has spent many months developing this Engine with and for the PMDA, and now the industry—whether as users of P21 Community (P21C) or clients of P21 Enterprise (P21E)—can utilize it for expanded standards support, e.g., ADaMIG 1.1, in their eData submissions to the Japanese health agency.

In October, 2021, Pinnacle 21 was successfully acquired by Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation and regulatory science. In this post, we recap P21's founding impetus, share the benefits of joining Certara, and set expectations for the great things to come.

Despite continuous development of, and the quarterly updates to, CDISC Controlled Terminology, there is still a need for study-specific extensions to standard codelists.

Often, extensions to standard terminology are incorrect. For example, some users falsely believe that any new terms can be added to an extensible codelist and related data validation is not needed if new terms are listed in the define.xml. In this webinar, Sergiy Sirichenko will summarize industry metrics across many studies and sponsors to produce an overall picture of CDISC Controlled Terminology utilization. He will review common issues with implementation of controlled terminology and reinforce best practices for extending standard codelists.

SDTM Trial Summary (TS) domain is essential for regulatory submission and is part of FDA rejection criteria.

TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical Conformance Guide (TCG), FDA Technical Rejection Criteria, and numerous terminologies. Interpretation of validation results for TS can also be difficult. In this webinar, Kristin Kelly discusses the minimum set of parameters that should be included in TS and reviews common implementation issues.

The COVID-19 pandemic had an immense impact on people’s lives. The quick development of effective and safe vaccines as well as their availability are critical to public health.

Clinical trials for vaccines typically collect similar types of data. Preparing this data for submission requires knowledge of specific guidance from regulatory agencies and standards development organizations. In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance and other considerations for preparing vaccine studies for regulatory submissions. Also, Michael goes over common problems and inconsistencies seen in data of vaccine studies.