Pinnacle 21

Pinnacle 21® is a clinical data standardization and validation software platform developed by Certara, designed to help clinical teams transform raw trial data into submission-ready deliverables. It is built for biotech, pharma, and CRO organizations that need to standardize, validate, and harmonize clinical data in line with global regulatory requirements, including CDISC, FDA, PMDA, and NMPA standards. With over 19,000 users and 17 years of leadership in CDISC-compliant data standardization, Pinnacle 21 is a trusted solution for accelerating timelines and ensuring data integrity from study setup through regulatory submission.

The platform integrates metadata management, continuous data validation, and collaborative workflows in a single centralized environment. By bringing together internal stakeholders, CROs, vendors, and developers, Pinnacle 21 reduces risk, shortens time to analysis, and enables the efficient production of CDISC datasets, Define.xml files, and Study Data Reviewer's Guides — all without requiring code, XML, macros, or scripts.

Core Capabilities and Software Modules

• Clinical Metadata Repository (CMDR): Centralizes and harmonizes metadata for eCRFs, data transfers, and submission datasets, aligning with CDISC, FDA, PMDA, NMPA, and in-house standards to enable reuse of standardized study metadata across studies.
• Clinical Trial Design: Automatically creates compliant trial designs from scanned data and relevant standards, including auto-fill and validation of trial design datasets.
• CRF Design and EDC Build: Enables the rapid creation of compliant case report forms (CRFs) and electronic data capture (EDC) systems, with support for platforms such as Rave and Veeva, including edit checks and visit structures.
• External Data Exchange: Provides a collaborative cloud-based platform for designing transfer specifications with each vendor and accepting non-CRF vendor data packages.
• Clinical Data Validation: Instantly checks submission datasets against acceptance criteria and generates a detailed log of issues to resolve, with real-time validation that identifies issues as data is entered.
• Issue Management: Allows teams to collaborate with CROs, developers, and other stakeholders in a central workspace to resolve issues discovered during validation in-stream.
• Define.xml: Automates the creation of Define.xml 2.0 files for SDTM, ADaM, SEND, and legacy datasets, delivering an 80% reduction in effort compared to manual approaches.
• Reviewer's Guide Support: Pre-populates and auto-generates Study Data Reviewer's Guides (SDRG) and Analysis Data Reviewer's Guides (ADRG) with a single button push.
• SDTM Specification Management: Enables teams to define, validate, and manage SDTM mapping specifications in one collaborative workspace, automating compliant SDTM mapping specs.

Enterprise Tiers and Deployment Options

• Pinnacle 21 Enterprise serves as the foundational platform, covering validation, Define.xml, Reviewer's Guide, trial design, issue management, and mapping specifications.
• Pinnacle 21 Enterprise Plus extends the platform with additional modules including CRF Creator, Data Exchange, and the full Clinical Metadata Repository for standards governance.
• Additional modules can be added to the Enterprise platform according to organizational requirements, allowing teams to scale functionality as needed.
• The platform supports cloud-based collaboration, enabling distributed teams and external partners to work together within a shared environment.

Community Resources and Validation Rules

• A comprehensive listing of SDTM, SEND, ADaM, and Define-XML validation rules is available, covering FDA, PMDA, and NMPA requirements, and is fully browsable and searchable.
• A community forum provides a space for discussing standardization and validation topics, exploring technical questions, and receiving peer support.
• A free community version of the Validator, Define.xml Generator, Data Converter, and ClinicalTrials.gov Miner is available for download.

Key Benefits and Performance Metrics

• More than 19,000 users rely on Certara Pinnacle 21 Enterprise for clinical data standardization and submission readiness.
• Teams report an 80% reduction in effort when creating Define.xml files compared to manual methods.
• The platform has maintained 17 years of leadership in CDISC-compliant clinical data standardization.
• Pinnacle 21 shortens timelines to analysis and submission-ready datasets by integrating metadata management and continuous validation in a single workflow.
• The software reduces the risk of regulatory rejection by ensuring datasets are validated against globally recognized standards throughout the clinical data flow.

Pinnacle 21 is backed by Certara's technical support team, which combines deep expertise in clinical data standards with decades of experience helping clients achieve regulatory compliance and expedite submissions. The platform is suitable for organizations of all sizes — from emerging biotech companies to large pharmaceutical firms and CROs — seeking a trusted, scalable solution for clinical data management and regulatory submission readiness.