Pinnacle 21

Engine releases, software updates, and P21E news 

Announcements

Being aware of the limitations of the CDISC "CORE" engine

P21 Community - Experimental Engines Advisory

What's New in PMDA 2411.1

Engine Updates

P21E and FDA deliver a major validation engine release. Learn what's in it, what you need to configure, and how it will be deployed.

What's in the 2508.0 validation engine suite?

Explore the updates to Japan's PMDA validation rules

What's New in PMDA Engine 2411.0?

Learn where you can find the answers you need for a smoother submission and review.

Webinar: SDTM Beyond the Implementation Guide

Best practices to incorporate bi-directional mapping for your source data workflow

The Challenges of Mapping Source Data to SDTM

Learn about the newest recommended CDISC dataset, how it is structured, what variables are included, and more

What is ADNCA (and why is it important)?

Learn about the changes to rules, messages, descriptions, algorithms and more in this version of the P21, FDA, and NMPA Validation Engines.

What's in the 2405.2 Validation Engine update?

Are you measuring the right things? What metrics you might want to monitor, how to obtain those metrics, and what that can all mean.

KPIs in Clinical Trial Data Management

What changed in PMDA Validation Engine version 4.0 as of March 2023

PMDA Engine Update: 2211.0

Metadata used to be an afterthought. Today, it’s the architecture of data confidence.

WEBINAR: Metadata as Infrastructure: Designing for Reuse, Insight, and Auditability

In case you missed it... you can find recordings of our public webinars and Q & A right here in our Help Center, 

Pinnacle 21 Webinars

Sowing Seeds of Inspiration: Letters to a Pre-Scientist

Featured Articles

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