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Clinical Trial Design

Pinnacle 21 clinical metadata repository
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Streamline clinical trial design with greater collaboration, increased traceability, and real-time validation

Create collaborative, compliant clinical trial designs

A clinical trial design is the blueprint for ensuring that the relevant data is collected, in the correct format, in a way that is consistent with study protocol, and compliant with the standard. The outdated practice of manually extracting protocol content and pasting into spreadsheets is time-consuming and often at risk of human error. Plus, validation against the protocol and standard to ensure compliance involves a series of unnecessary extra steps – that extends timelines and increases costs.

Not only that, without a documented audit trail, version tracking and change management requires a lot of email back-and-forth. Pinnacle 21 Enterprise (P21E) allows your team to build clinical trial designs collaboratively, as well as document, track, and validate in a centralized platform – the same platform that 95% of top pharmas have trusted for data validation for more than a decade.

Pinnacle 21 Clinical Trial Design mofule

Why use Pinnacle 21 Enterprise for clinical trial design?

Jumpstart your next trial design by creating from scanned data in P21E, or by building from a standard. P21E automatically performs in-cell validation checks and flags non-compliance issues in real-time – so your team can research and resolve them collaboratively in the platform.

Automatically create compliant trial designs

Rather than manually creating your trial design from the protocol, P21E uses your scanned data or relevant standard to auto-populate the trial summary dataset tab. Now you’ll automatically have a compliant and consistent trial design!

Ensure compliance

In-stream cell validation checks your trial design for compliance against the data standard you’ve selected. The same applies to uploaded datasets and scanned data. Cell warnings will alert you to resolve any issues, enabling complete compliance in your trial design.

Collaborate in the cloud

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.

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Complete traceability

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 across your trial designs.

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Deliver trial insights

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. Now data insights are at your fingertips!

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Create designs upfront

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. Plus, biostats teams benefit from seeing your validated trial designs before the trial is underway!

Ensure compliant clinical trial designs with greater collaboration and full traceability

如何更好地使用 Pinnacle 21 Enterprise

De-risk your trials

Now you can confidently manage trials from design to data validation. Developing your trial design collaboratively in our cloud 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 time and manual labor

You’ll 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 you to get studies set up faster and more efficiently.

Avoid submission delays

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.

SDTM mapping & SDTM conversion with Pinnacle 21

Automatically create compliant, customized trial designs

Select your SDTM/SEND data package

Create a design from a standard/scanned data before study startup

Import .xlsx, .csv, or .xpt files to auto-create and populate trial design domain tabs

Collaborate with teams to add/remove parameters

Export your trial design as a machine-readable .xpt file

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