Pinnacle 21 by Certara currently offers 3 modules for all P21E subscriptions for environments on P21E v5.3.0-6.2.0. As of P21E v6.2.0, the following features and included in these modules:
1️⃣ Foundational Pinnacle 21 Enterprise
Validation - ensure the accuracy, reliability, and integrity of study data, and ensure it is consistent, complete, accurate, and adheres to standards to help teams make informed decisions and prepare for regulatory submission
Issue Management - jumpstart the research, review, and resolution of problems with your data that could impede (or even derail) regulatory review in a single, collaborative workspace
Define Designer - build and validate this critical document designed to describe the format and content of submitted datasets in the same place you'll validate, manage, and resolve issues
Custom Standards & Terminologies (export only)
Custom Metadata - streamline workflows by setting and using system or organization-specific defaults for status, source, and assignee, and provide direction to the entire team through P21E's unique Fix Tips and Explanations capabilities
Trial Design - quickly build/generate a Trial Design Document that can be exported into a machine-readable, standardized XPT output that agency reviewers can review and quickly understand
Reviewer’s Guide - automatically generate critical documents that provide context and clarity for agency reviewers and help them understand the study design and data structure related to the data being reviewed
2️⃣ P21 Advanced Tier 2 - Data Exchange (DX)
Spec Designer - foster collaboration and clarity between sponsors and vendor partners by importing, creating, and/or maintaining Data Specifications in P21E's Data Exchange module
Sample Data Generator - deliver a file of what each vendor's data should look like based on the agreed-upon Data Transfer Specification to keep study data consistent and compliant from collection to submission
Vendor data file validation and delivery to EDC - deliver and integrate data generated by external vendors into your Electronic Data Capture (EDC) system, including Veeva, for centralized management and analysis
3️⃣ P21 Advanced Tier 3 - Metadata Repository (CMDR)
Custom Standards & Terminologies (via Standards Designer) - enhance CDISC standards with your company-specific metadata created and maintained in a single location accessible to your entire study team, or use them portfolio-wide
Standards Governance - manage and approve change requests, and track versions, edits, and deviations via a system-generated changelog
Source Data Mapping - transform raw clinical trial data into a standardized format for regulatory submissions by matching source data elements to SDTM domains and variables, along with data transformation and quality checks
Reference Data - create blueprints via structured sets of information used to standardize and organize data collected, ensuring consistent data representation across all your organization's sites and studies
Form Spec Designer (for release in P21E v6.3.0) - create and reuse Form Specs at the global level, and pull them down to reference during the Study-level spec creation process to ensure they adhere to CDISC Implementation Guidelines or your company specifications
Rules Designer (for release in P21E v6.4.0) - create custom rule checks based on your organization's needs and SOPs, then test them to ensure they produce the expected results
👣 What's Next?
With the release of P21E v6.4.0, P21E will allow even greater flexibility for your team by restructuring which features are included in each module and expanding our offering to 5 modules, including foundational P21E.
Contact your Customer Success Manager to get connected to more information on the modules and features available for your team now and take advantage of the additional functionality you can gain by investing in the advanced modules today.