Pinnacle 21 clinical data standardization software empowers clinical teams to standardize, validate, and harmonize data effortlessly. Achieve flawless submissions and accelerate development with confidence.
Pinnacle 21
Achieve submission ready conformance with Pinnacle 21 clinical data standardization software
Learn more about Pinnacle 21 clinical data standardization software
Optimize quality & speed from setup through submission with clinical data standardization
Manage and optimize your clinical trial data from the start.
Shorten the time to analysis – and submission-ready CDISC datasets, Define XML files, and Study Data Reviewer’s Guides.
Collaborate with internal stakeholders, CROs, vendors, developers and others in a central workspace.
Why implement clinical data standardization software?
The Pinnacle 21 clinical data management software platform transforms clinical data into submission-ready deliverables – enhancing data quality across studies, and validating datasets against global regulatory standards.
By integrating metadata management and continuous data validation in a collaborative platform, Pinnacle 21 speeds timelines, reduces risk, and ensures data integrity throughout the clinical data flow.
Metadata management for eCRFs and submissions.
Centralize metadata for eCRFs, data transfers and submission datasets, and harmonize in line with clinical data standards, such as CDISC, as well as your own in-house standards.
Real-time data validation with issue tracking.
Collaborate with CROs, developers, and others in a central workspace to resolve issues discovered during validation.
Effortless collaboration across both internal and external clinical teams.
Design your transfer specifications with each vendor and accept data packages in the cloud.
Leaders in clinical data management
19,000
users of Certara Pinnacle 21 Enterprise
80
reduction in effort when creating define.xml files
14
years of leadership in CDISC compliant clinical data standardization
Continuous data validation
Insist on clinical data standardization
Pinnacle 21 for data standardization streamlines metadata management, collection workflows, and external vendor data exchange, helping you manage and optimize your clinical trial data from the start.
Get fit to submit
Pinnacle 21 for data validation shortens the time to analysis and submission-ready CDISC datasets, define.xml files, and Study Data Reviewer’s Guides.
Why choose our clinical data standardization software?
The team behind our technology bring decades of experience in clinical data management, as well as deep rooted knowledge of industry and regulatory standards, such as CDISC.
Alongside innovative technology, our compliance and metadata management expertise position us as your trusted partner for expedited submissions and regulatory compliance.
“Working in a platform like Pinnacle 21 has helped us meet the needs of our clients faster. And they can be confident that the data we provide is in a standardized format they can use to drive decisions right away.”
Liming Fang
Deputy General Manager, Longcharm Biomedical Technology
Pinnacle 21 resources
Download Pinnacle 21® Community 4.1.0
Download the community version of Validator, Define.xml Generator, Data Converter, and ClinicalTrials.gov Miner.
Download now
Support documentation
Browse documents related to Pinnacle 21 Community, data validation & quality assessment, CDISC standards, and regulatory agencies.
Learn more
Community forum login
Discuss the latest standardization and validation news, explore technical topics, and help shape our solutions.
Access community forum
Validation rules
Search, sort, and filter our comprehensive table of rules for SDTM, SEND, ADaM and DEFINE-XML. FDA, PMDA, NMPA are all included.
Learn more
Support from our technical experts
Need a hand preparing your SDTM datasets or submission deliverables? Our technical support team combines expert knowledge of clinical data standards with decades of experience helping thousands of clients achieve regulatory compliance and expedited submissions.
Submission-ready data including SDTM, ADaM, Define.XML and Study Data Reviewers’ Guides
Pinnacle 21 Enterprise validation checks
Review of data for consistency, completeness and scientific integrity
TLF programming
Data standardization and validation resources
View all
Aligned with CDISC data standards
The Clinical Data Interchange Standards Consortium (CDISC) develops data standards. Many regulatory agencies require drug submissions to conform to CDISC data standards. Pinnacle 21 embraces all CDISC guidance.
Transform clinical data with Pinnacle 21
Schedule a consultation to see how Pinnacle 21 clinical data management software can accelerate your path from study design to submission.
Master data standardization and validation
Experience a new dimension of submission efficiency
Harmonize data from diverse sources