Pinnacle 21 Clinical Data Management & Automation Suite
Pinnacle 21 Enterprise
Clinical Data Management & Automation Suite
Go from protocol to submission in half the time!
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!
What can you do with Pinnacle 21 Enterprise?
Manage Standards & Build Studies
Manage External Vendor Data
Validate & Prepare Submission Deliverables
How you’re better off with Pinnacle 21 Enterprise
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.
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.
Superior data
quality
Ensure the quality and integrity of clinical trial data with real-time validation, issue management and resolution.
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
Pre-approved, standardized content and built-in validation puts you in the strongest position for gaining FDA approval.
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.
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!
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!
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.
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!
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 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
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!
