See siera in Action
Curious how siera works? Watch this quick demo to see how it seamlessly integrates with TFL Designer for a fully automated workflow.
siera: Streamlining CDISC ARD Generation
With siera, generating Analysis Results Datasets (ARDs) has never been easier. Our R package seamlessly integrates CDISC’s Analysis Results Standard (ARS), transforming structured metadata into ready-to-run R scripts. Here’s how siera simplifies the process:
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Effortless Metadata Ingestion
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Accepts JSON and Excel formats (aligned with CDISC standards)
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Reads ARS metadata to define analysis components automatically
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Seamless TFL Integration
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Produces ARDs that align with TFL outputs
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Ensures traceability, reproducibility, and automation
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Instant R Script Generation
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Transforms ARS metadata into ready-to-run R scripts
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No manual programming—just plug in your ADaM dataset
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Generates the ARD for seamless TFL reporting
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Smart Automation for Clinical Analysis
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Identifies Analysis Sets (e.g., SAFFL = "Y")
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Groups data dynamically (e.g., Group by TRT01A)
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Handles subsets and filters (e.g., AGE > 65)
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Performs statistical operations (Mean, SD, etc.)
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siera takes the guesswork out of clinical data analysis
Eliminate inefficiencies, reduce manual coding, and let automation handle the heavy lifting. With siera, your analysis workflow is faster, smarter, and fully CDISC-compliant.
Automate Your TFL Workflow
Most Biostats teams still rely on traditional, manual methods to generate Tables, Figures, and Listings (TFLs). Static shells require programmers to manually write code based on domain expertise—a time-consuming and error-prone process.
With siera, that changes,
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Machine-readable ARS metadata replaces static shells
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Automation engine ingests metadata and programmatically generates ARDs
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No manual scripting needed—just plug in your ADaM dataset and run
By leveraging Siera and CDISC-compliant ARS metadata, your team moves one step closer to fully automated TFL generation.
Full Transparency & Code Ownership
Unlike black-box automation solutions, siera gives you full visibility and control over your generated outputs.
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R scripts are fully accessible, customizable, and transparent
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One R script per ARD, one ARD per TFL output
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Modify and integrate with existing workflows as needed
This means you’re not just automating—you’re empowering your team with tools that enhance, rather than replace, their expertise.
Seamless Integration & Expert Support
siera is developed and maintained by Clymb Clinical, a leader in clinical data automation. The package seamlessly integrates with TFL Designer, which automatically generates ARS metadata—removing the need for manual setup.
And when you need help? Our expert team is here to support you, ensuring:
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Smooth onboarding and integration
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Ongoing updates & enhancements
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Dedicated assistance whenever you need it
Built on CDISC Standards, Future-Proofed for Compliance
Many organizations attempt in-house automation, but without an industry-wide standard, scalability and regulatory compliance become major hurdles.
siera is different because it is built on CDISC’s ARS standard, ensuring:
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Full alignment with foundational CDISC models (SDTM, ADaM, and ARS)
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Long-term sustainability & regulatory confidence
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Ongoing CDISC updates to keep your automation current
With siera, your automation strategy isn’t just efficient—it’s future-proof and fully compliant.
Get Instant access to our ARS Whitepaper!
The Analysis Results Standard (ARS), developed by CDISC, is designed to streamline, automate, and standardize the way clinical trial analysis results are structured. It ensures automation, reproducibility, reusability, and traceability across datasets—eliminating inefficiencies caused by inconsistent reporting methods.
At its core, ARS provides a Logical Data Model that defines analysis results and their associated metadata, creating a consistent framework for organizing and automating clinical trial outputs, such as tables and figures.
Got Questions? We've Got Answers
What do I need in order to use siera?
In order to use siera, the user needs a populated ARS (Analysis Results Standard) metadata JSON file describing the reporting event outputs. This ARS metadata can be produced by using TFL Designer. Furthermore, the ADaM datasets underlying the outputs described in the ARS metadata is required as input.
How would using siera impact the current workflow of TFL generation?
In traditional TFL generation, each TFL is manually and individually programmed. With siera, there would be a greater focus on setting up the ARS metadata prospectively, which may require a larger effort in terms of metadata configuration. Once the metadata is configured, however, siera automatically generates results (ARDs) for all outputs. The final step of creating the display from the ARD, is not in the scope of siera, but combining the ARD with Display Metadata would fill this gap (consider looking at tfrmt R package).
Where can I learn more about ARS, using siera, or finding support for implementation?
As a foundational CDISC standard, ARS can be found here: Analysis Results Standard. The GitHub page for siera, with code examples, can be found here: GitHub - siera. If any assistance or consulting services are required, feel free to reach out to info@clymbclinical.com.
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