Pinnacle 21: Achieve submission ready conformance with Pinnacle 21 clinical data standardization software

Your clinical trial is nearing completion, data is flowing in from multiple sources, and regulatory submission deadlines are looming. Yet your team is drowning in validation issues, struggling with metadata inconsistencies, and coordinating with external vendors feels like herding cats. Sound familiar?

You're not alone. Clinical data standardization has become one of the most pressing challenges in modern drug development, where a single data integrity issue can delay submissions by months and cost millions.

Pinnacle 21 is a clinical data management software platform that systematically transforms raw clinical data into regulatory submission-ready deliverables through integrated metadata management and continuous validation processes. The platform enables clinical teams to standardize, validate, and harmonize data against global regulatory standards while facilitating collaboration between internal stakeholders, CROs, vendors, and developers within a centralized workspace. By optimizing data management from trial initiation through final submission, Pinnacle 21 accelerates development timelines, reduces compliance risk, maintains data integrity throughout the clinical data flow, and generates compliant CDISC datasets, Define XML files, and Study Data Reviewer's Guides that ensure flawless regulatory submissions with enhanced confidence and efficiency.

Key Features of Pinnacle 21 Enterprise

Metadata management for eCRFs and submissions: The Pinnacle 21 Clinical Metadata Repository (CMDR) provides a centralized platform for managing clinical trial metadata, ensuring consistency, compliance, and efficiency across studies. By leveraging reusable, validated standards, organizations can significantly accelerate study builds—often completing setup in under six weeks—while maintaining high-quality, compliant outputs. The CMDR enhances governance by enabling teams to define clear workflows, giving greater visibility and control over study content development. With a library of approved metadata, the platform promotes standardization and quality, ensuring consistency across future studies and submission datasets, and ultimately streamlining the path to regulatory compliance.

Real-time data validation with issue tracking: Transform the way clinical data issues are managed by a real-time validation platform with robust issue tracking capabilities. Designed to support decentralized teams, this enables efficient assessment, triage, and resolution of data issues—all within a collaborative workspace that maintains a full audit trail for regulatory compliance. Collaborate with CROs, developers, and other stakeholders in a central workspace to resolve issues discovered during validation, eliminating the inefficiencies of scattered communication and local spreadsheets. Each issue comes with detailed explanations, including rule violations, impact on compliance, and customizable annotations such as fix tips and internal tags. There is also  a powerful data fitness score—ranging from 0 to 100—to help teams prioritize issues that have the greatest effect on submission readiness. This score, combined with performance metrics and trend tracking, empowers teams to enhance data quality and accelerate submission timelines with confidence.

Effortless collaboration across both internal and external clinical teams:

Streamline the management of non-CRF vendor data with internal teams and external partners with a platform that can be used to collaborate efficiently. With over 70% of clinical trial data now coming from non-EDC sources, manual methods like spreadsheets and email threads are no longer sustainable. This allows teams to design data transfer specifications with each vendor and receive data packages securely via the cloud, simplifying the entire exchange process. Real-time validation ensures that vendor data is checked instantly against defined standards, with immediate feedback on any issues. By enabling shared access to specifications, validation reports, and audit trails, this reduces delays and improves data quality. Dashboards provide clear visibility into timelines, data delivery, and issue resolution, making it easier to manage vendor performance and maintain compliance across studies.

Regulatory compliance 

The software ensures regulatory compliance by automating and aligning clinical trial design and CRF development with global standards. It enables teams to generate protocol-compliant study designs using pre-approved templates and metadata, ensuring consistency across trials. Additionally, the platform supports rapid and standardized CRF and EDC builds, embedding regulatory and CDISC standards. This structured approach reduces manual effort, minimizes errors, and guarantees that your study design and data collection tools meet FDA, PMDA, and other international regulatory requirements from the outset.

This clinical data standardization software enables clinical teams to seamlessly standardize, validate, and harmonize their data. This streamlined approach ensures regulatory-compliant submissions while accelerating development timelines through enhanced data confidence and quality assurance.

Ready to transform your clinical data management? Pinnacle 21 offers comprehensive consultation to understand your specific challenges and design a solution that fits your organization's needs.

Whether you're a global pharmaceutical company managing dozens of concurrent trials or a biotech startup preparing for your first regulatory submission, Pinnacle 21 scales to meet you where you are and grows with your success.

Don't let data management challenges slow down your life-saving work. Schedule a consultation with AKTHealth at info@akthealth.com for Pinnacle 21 today and discover how clinical data standardization software can accelerate your path from study design to successful submission.

Transform your clinical data. Accelerate your timelines. Achieve regulatory success.