TFL Designer Community Release v2.0

1st & 2nd October 2025

Description

Clymb Clinical hosted this webinar to introduce the TFL Designer Community Version 2.0.0. This session highlighted how TFL Designer further streamlines the creation of Tables, Figures, and Listings (TFL) mock-up shells while aligning with the latest CDISC Analysis Results Standard (ARS). The webinar featured a live demonstration of the platform’s upgraded capabilities, including simplified study setup, enhanced statistics configuration, table of contents filtering, and export customization. Speakers also showed how annotations and metadata are captured during design to support consistent review and downstream automation.

Key highlights included the expansion of the TFL Designer template library, improvements for comparative statistics and shift tables, richer formatting options such as superscript, subscript, and display notes, and the ability to export shells and ARS-structured metadata in multiple formats, such as JSON, Excel, RTF, and PDF. The session also emphasized the distinction between the Community and Enterprise versions of TFL Designer, with Community being a free, web-based solution, while Enterprise adds governance features and integrations with automation tools such as Sierra, Atlas, and AI Code Generation to help teams move from shell design to analysis more efficiently.

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Q&A

My company is moving to requiring ADSLpre as the first dataset and ADSL is run last. Would this cause any issues?

No. However, you can still continue to choose ADSL as your source dataset for TFLs. Since datasets are generated prior to TFLs, your ADaM sequencing (ADSL-pre vs. ADSL) will not affect the workflow or metadata mapping.

Can you share more about the placeholder aspects of TFL library templates? What is the flexibility versus limitation?

Placeholders in the TFL Library provide flexibility by making templates reusable, consistent, and automation-ready through pre-populated metadata. They eliminate the need to start from scratch, allowing users to quickly build study-specific shells. This approach offers a strong starting framework, with the only consideration being the initial setup time required to define and build the placeholders.

Is there functionality to compare across products or studies, for example, to identify similarities or differences in TFLs or ADaM dataset mappings?

That functionality is not currently available in the Community version.

Is it easy to organize the TFL template or shell library by therapeutic area, indication, or other classifications such as BIMO listings?

Yes. The TFL Library supports grouping and filtering by multiple attributes, including Analysis of Interest, Compound, Therapeutic Area, Disease Area, and Reporting Event. Users can sort and filter them by any of these elements.

Will there always be a TFL limit of 25 per study?

At present, the Community version supports up to 25 shells per study. Enterprise users have expanded capacity and additional study-management features.

What has been the appetite for TFL Designer across small, medium, and large organizations?

Adoption has been strong across all organization sizes.

Smaller companies value the out-of-the-box standardization and reduced programming overhead.
Mid-size organizations leverage it to scale and unify reporting processes.
Large pharma benefits from automation, compliance alignment, and reduced redundancy across global studies.

Across all groups, the metadata-driven workflow is recognized for improving traceability, consistency, and readiness for automation using tools such as Siera and the AI Code Generator.

Is the Enterprise version self-hosted, or is it available only on tfldesigner.org?

The Enterprise version is a cloud-hosted single-instance dedicated SaaS solution managed by Clymb Clinical. It offers organization-specific workspaces, authentication, and audit trails, eliminating the need for local installation or maintenance.

Can Enterprise customers have custom URLs, such as company.tfldesigner.com?

Yes. Enterprise deployments will be configured with custom subdomains, allowing secure organization-specific access (for example, company.tfldesigner.com).

How does content get added to the Community Library? Are permissions required?

The Community Library contains curated templates sourced from FDA-STFIG, JPMA, and shells voluntarily contributed by verified users. No special privileges are required to contribute to the community library, and all new contributions are reviewed and approved before publication. Enterprise templates remain private unless explicitly shared for community inclusion.

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