Pinnacle 21 is a global leader in software for preparing clinical trial data for regulatory submission. Twenty-two of the largest 25 global biopharmaceutical companies trust Pinnacle 21 Enterprise. It is the same platform used by the US FDA and Japan’s PMDA to review a submission’s data quality, CDISC compliance, and fitness for use.

You too can judge datasets against their rejection criteria to fix issues in advance, mitigate risk, and accelerate the review process.

  • Use the dashboard and scoring algorithm to monitor progress toward submission readiness.
  • Track changes between validation runs with clear before and after views.
  • Dig deeper into your data composition with our pre-built reports to surface patterns and inconsistencies.
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What’s your data fitness score?

Our software checks whether your data comply with CDISC standards, controlled terminology, and dictionaries like MedDRA and WHODrug. This is your final checkpoint before datasets embark for the FDA, PMDA, or China’s NMPA. It checks whether your data adhere to each agency’s business rules. Issues may derail their standardized review tools, so we offer insights and “Fix Tips” so that you stay on track.

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Catch and fix quality issues continually

Fix quality issues at data cuts while studies are ongoing, and validate data early and often so that you minimize your risk of regulatory delays. Our embedded feedback loop helps both you and your collaborators. Sponsors can share access to the platform with partners and vendors. Furthermore, you can upload your custom standards, terminology, and business rules into our validator to see which are CDISC-compliant and which need work. Ensure that everyone’s deliverables are perpetually compliant and submission-ready.

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Maintain a single source of truth with seamless issue management

Collaborate with devs and external vendors to work through issues across decentralized teams and standardize datasets. Process batches fast with bulk actions and automations. Set custom defaults for validation issues by pre-setting their status and source. Bring in your own workflow. Our process-agnostic platform enables any complex use case. With a suite of tags and filters, you can fix issues immediately with programming, delegate them, or let them resolve over time.

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Make Define.xml files ready to submit up to 80% faster.

Define.xml files document the metadata that describe your tabular dataset structure. They tell reviewers the structure of your data and its origins. Many studies fail due to faulty Define.xml files. Our Define Designer creates these files automatically. It lets you manage and edit these files directly like a spreadsheet. No need to write any code, XML, macros, or scripts. Our solution gives you one-stop support for datasets in SDTM, SEND, ADaM, and Analysis Result Metadata. You can even auto-populate metadata, validate in real-time, and compare versions.

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我们的专家
Max Kanevsky Chief Technology Officer, Software

Max has spent his entire career in data standardization. In 2008, he created an open-source toolkit for implementing CDISC standards. As these standards transformed clinical data exchange, Max grew Pinnacle 21 as its CEO to be a global leader in preparing clinical data for submission, enabling clean data pipelines from sponsors to health authorities.

Sergiy Sirichenko Director of Consultative Services

Sergiy’s career spans consultative statistical analysis and the promotion of data standards. Along with Max, he co-founded Pinnacle 21 to bring scalable software solutions to this space. He is a user advocate for all of Pinnacle 21’s solutions, and serves as a Subject Matter Expert on FDA JumpStart, coreDF (the FDA’s instance of P21E), and eDATA projects.

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