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Pinnacle 21 Clinical Data Management & Automation Suite

Pinnacle 21 Enterprise
Clinical Data Management & Automation Suite

Go from protocol to submission in half the time!

Pinnacle 21 by Certara

Increase the speed and quality of your clinical trial submissions

The Pinnacle 21 Enterprise (P21E) next generation cloud suite optimizes the end-to-end clinical trials process. Increased efficiency, higher data quality, and improved data flow across stakeholders are now at your fingertips!

Costly, resource heavy processes are replaced by innovative technology, which empowers sponsors and CROs to automate manual processes, and speed lifesaving drugs to market faster than ever before!

Pinnacle 21 Clinical Data Management & Automation Suite

What can you do with Pinnacle 21 Enterprise?

Manage Standards & Build Studies
Manage External Vendor Data

How you’re better off with Pinnacle 21 Enterprise

Start trials in half the time with Pinnacle 21

Start trials in less than half
the time

Build validated studies in less than 6 weeks by standardizing and reusing approved study content. With faster study setup and earlier enrolment, lifesaving drugs can be brought to market sooner.

Make earlier informed decisions with Pinnacle 21

Earlier informed
decisions

Get real-time SDTM data from first patient in (FPI), and make informed safety and efficacy decisions, earlier, with on-demand insights.

Achieve superior data quality with Pinnacle 21

Superior data
quality

Ensure the quality and integrity of clinical trial data with real-time validation, issue management and resolution.  

Improve compliance with Pinnacle 21

Improve
compliance

Ensure regulatory compliance and accelerate submission readiness with data quality control, CDISC conformance, and fitness-for-use reports.  

Maximize chances of submission approval with Pinnacle 21

Maximize chances of submission approval

Pre-approved, standardized content and built-in validation puts you in the strongest position for gaining FDA approval.

Reduce costs and maximize profits with Pinnacle 21

Reduce costs
& maximize profits

Save labor, time, and costs as manual work is replaced by automated processes. Now you can increase productivity, as skilled resources can be diverted to more profitable projects.   

Pinnacle 21 Clinical Metadata Repository

Standardize & reuse content in your Clinical MDR

P21E provides a centralized clinical metadata repository (CMDR) to share, standardize, manage and reuse standards across studies at every stage.

Building a global library of compliant, pre-approved standards saves time and effort on study setup, and ensures quality and consistency across studies.

Not only that, with P21E CMDR as your foundation, you can automate EDC build, and drive further automation downstream across SDTM and submission deliverables.

Design & build EDC studies in under 6 weeks

Design CRFs in P21E and see how forms will look for your EDC before study build. Being able to edit and visualize forms, and carry out stakeholder review within the platform, majorly shortens review cycles – ultimately accelerating study build and time to data collection.

And because the platform is EDC agnostic, it’s just one click to build your full EDC!

Plus, once CRFs are approved, you can add them to your CMDR library of standardized content and used forevermore!

Pinnacle 21 EDC integrations - use multiple EDCs

Run SDTM Conversions From First Patient In

Get your hands on trial insights as soon as patient data is collected!

With spec design, mapping, and conversion tools embedded in our clinical MDR, you’ll have SDTM datasets in just 2-4 weeks. That’s because CRFs are designed in line with SDTM from the outset – so mappings can be done at study design.

You’ll be able to run SDTM conversions on-demand, and make informed safety and efficacy decisions earlier than ever before!

SDTM datasets in Pinnacle 21
High quality third party data insights in Pinnacle 21

Get high quality external vendor data insights, on time!

P21E eases and expedites the process of ingesting non-CRF and external vendor data.

Specification tools allow you to work on up-to-date specs in the platform. Then easily create data transfer specs by modifying and merging content from your clinical MDR.

Secure vendor-sponsor data transfers with in-stream validation and structural checks ensure high quality deliverables from the outset.

With our platform dashboards and analytics, informed decision making is at your fingertips.

Pinnacle 21 Clinical Data Management & Automation Suite

Request a free demo

Book a free no-obligation demo and see how better off you could be with Pinnacle 21 Enterprise!

Create define.xml up to 80% faster & automate your Reviewer’s Guide

Automatically create define.xml files in P21E’s ‘zero coding’ platform.

With support for datasets in SDTM, SEND, ADaM, and Analysis Results Metadata, compliant define.xml becomes a breeze!

Plus, you can auto-populate metadata, validate in real-time, and version your define.xml files for easy comparison.

The platform helps you auto-fill your Reviewer’s Guide template. With all the heavy lifting already done, you’re just one click away from producing your Reviewer’s Guide!  

Clinical Study Data Reviewer's Guide in Pinnacle 21
Data fitness - Pinnacle 21 platform

Reduce risk & ensure submission readiness

Quality control and compliance underpins every aspect of our platform. Data validation and conformance checks are performed at every stage of the trial’s lifecycle, from design onwards.

With issue management, you can easily collaborate with teams to track and resolve errors and perform interim analysis – eliminating risk at every stage.

And when it comes to submission, you can preview data fitness results before giving data to the FDA or PMDA.

That’s why we’re trusted by 24/25 top pharmas, and 11/15 top CROs!

Pinnacle 21 - Formedix by Certara

Pinnacle 21 and Formedix have joined forces!

Our unified platform will improve collaboration and data flow across key stakeholders, whilst enabling faster, higher quality trials, from design to submission.

Find out more about ryze > visit formedix.com

Find out more about P21 > visit pinnacle21.com

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Get a free demo of Pinnacle 21 Enterprise Clinical Data Management & Automation Suite

Complete the form to book your no-obligation demo of the P21E Clinical Data Management & Automation Suite… and see how better off you could be!

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