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Pinnacle 21 Enterprise (P21E) empowers your team to create compliant clinical trial designs with ease.
By automating manual processes, ensuring real-time validation, and fostering collaboration, P21E reduces errors, accelerates timelines, and enhances regulatory readiness. It’s the same platform that 95% of top pharmaceutical companies have trusted for data validation for over a decade.
P21E simplifies clinical trial design by automating compliance checks, enabling cloud-based collaboration, and ensuring complete traceability. This centralized platform allows teams to work together seamlessly, track changes in real-time, and generate insights that drive better outcomes.
Rather than manually creating your trial design from the protocol, P21E uses your scanned data or relevant data standard to auto-populate the trial summary dataset tab.
In-stream cell validation checks verify your trial design, datasets, and scanned data for compliance against the relevant data standard. Warnings alert you to resolve any issues, easing the validation process.
Save time and effort by collaboratively managing designs in a central cloud platform. P21E’s chat functionality eases collaboration, with full chat history, and a complete audit trail for streamlined issue resolution.
P21E provides complete traceability, with full tracking of all versions of your trial design. With real-time change log tracking, you’ll have a full audit trail, and be firmly in control of versioning and change management.
Easily perform analysis and extract key insights with P21E. Run comparison reports across different trial design versions, or across trials, for example. Even find common features, or analyze planned vs. actual patient treatments and visits.
With P21E, designs can be done upfront – from study startup. This puts you in the best position for regulatory review, since rules are enforced from the outset.
Confidently manage trials from design to data validation. Developing trial designs collaboratively in the P21E platform – with a complete audit trail of changes – eases issue resolution. And having in-stream validation checks mitigates the worry and risk of non-conformance.
Save hours of manual spreadsheet work not having to create trial designs by hand from the protocol. Being able to automatically create trial designs from a standard or scanned data removes labor intensive admin, and allows for faster and more efficient study set up.
Since trial design datasets can be generated upfront – before patient data has been collected – there’s no rush to create it later, risking end of trial delays. Creating designs upfront also ensures that rules are enforced from the outset, and you’re well placed for regulatory reviewers like the FDA to easily understand your trial design.
Driving innovation in clinical trial design
With a proven track record of reducing study setup time by up to 85%, the Pinnacle 21 Enterprise platform empowers drug development professionals to achieve better outcomes – through cutting-edge technology and industry-leading technical support.
Partner with Certara to streamline your clinical trial design strategy, and accelerate the path to regulatory submission.
Your data is safe with Pinnacle 21 Enterprise. Our platform is ISO-certified, ensuring the highest standards of data security and compliance.
See how Pinnacle 21 Enterprise can revolutionize your clinical trial design process.
Pinnacle 21 Enterprise is a centralized platform for clinical trial design, offering automated compliance checks, cloud-based collaboration, and complete traceability.
P21E performs in-stream validation checks to verify compliance with selected data standards, flagging issues in real-time for resolution.
Yes, P21E enables you to create compliant trial designs upfront, ensuring readiness for regulatory review and avoiding submission delays.
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