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The Future of Validation in Clinical Trial Analysis

Eliminate double programming and radically transform clinical trial validation to vastly accelerate submissions and approvals.

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What is Validated by Verisian?

Outdated validation techniques in clinical trial analyses waste billions while delaying critical treatments for patients. Today's approach, heavily reliant on double programming and manual processes, wastes time and resources while undermining the very quality it aims to guarantee.

The Validated by Verisian process solves this problem. Powered by Full Study Traceability, it enables the required paradigm shift in how clinical trial analyses are validated, it enables quicker and more confident decisions that move medicine forward and bring treatments to patients faster at a lower cost.

Full study traceability

Verisian uses advanced graph analytics to turn specifications, metadata, code, and data into a fully traceable dependency graph. All upstream dependencies and downstream effects of any dataset, variable, and TLF can be explored and validated across the entire study, providing complete transparency and unparalleled quality control.

Validated by Verisian

Validated by Verisian allows for faster, cheaper, and higher quality validation of clinical trial analyses. Based on full study traceability, the unparalleled transparency forces a paradigm shift in the understanding, communication, and quality of analyses, submissions, and regulatory reviews. This eliminates the need for traditional double programming, the current gold standard for quality control.

Bring AI to your clinical trial analysis

Verisian AI co-pilots are fine-tuned for and base their answers on full study traceability to provide high quality and evidence-based answers. The co-pilots can be tuned to company- or indication-specific contexts and write code, fix bugs, debug logs, and generate submission documentation.

Supporting pharmaceutical companies, biotechs, CROs and regulatory agencies

Trusted by Industry Leaders

Verisian's approach to overcome traditional methods in the clinical programming field using graph-based tech will revolutionize the industry, paving the way for efficient and cost-effective solutions in the future.

Ankur Sangani

Senior Statistical Programmer,
ex-Agati Clinical Informatics

The technology Verisian uses is new and revolutionary: building traceability from code is exactly the right way to know what really happened in a study.

Oliver Wirtz

Head of Analysis Standards & Reporting Quality,
Bayer

Verisian is exactly what the pharmaceutical industry has been waiting for, easy traceability of programs and CDISC, SDTM and ADaM mappings which will streamline clinical trials for the future.

Claire Springett

Statistical Programmer,
AstraZeneca

Verisian is advancing the kind of change this industry badly needs. Their technology is fundamentally designed to improve the speed, clarity, and reliability of the clinical data reporting pipeline.

Kyle Ireton

Senior Statistical Programmer,
Syneos Health

Verisian is helping us scale our statistical programming services by streamlining our clinical programming framework. We’re excited about the potential!

Miguel Pereira

Executive Director and Biostatistician,
Cogitars UK

Verisian's approach to overcome traditional methods in clinical programming for e.g. SDTM and ADaM using graph-based tech will revolutionize the industry, paving the way for efficient and cost-effective solutions in the future.

Ankur Sangani

Senior Statistical Programmer,
IQVIA

The technology Verisian uses is new and revolutionary: parsing study code and leveraging that is exactly the right way to know what really happened in a study.

Oliver Wirtz

Head of Analysis Standards & Reporting Quality,
Bayer

"The technology Verisian uses is new and revolutionary: parsing study code and leveraging that is exactly the right way to know what really happened in a study."

Oliver Wirtz, Head of Analysis Standards & Reporting Quality

Bayer

"Verisian is exactly what the pharmaceutical industry has been waiting for, easy traceability of programs and CDISC mappings which will streamline clinical trials for the future."

Claire Springett, Statistical Programmer

AstraZeneca

"Verisian is advancing the kind of change this industry badly needs. Their technology is fundamentally designed to improve the speed, clarity, and reliability of the clinical data reporting pipeline"

Kyle Ireton, Senior Statistical Programmer

Syneos Health

"Verisian is advancing the kind of change this industry badly needs. Their technology is fundamentally designed to improve the speed, clarity, and reliability of the clinical data reporting pipeline"

Kyle Ireton, Senior Statistical Programmer

Syneos Health

"Verisian's approach to overcome traditional methods in the clinical programming field using graph-based tech will revolutionize the industry, paving the way for efficient and cost-effective solutions in the future."

Ankur Sangani, Senior Statistical Programmer

ex-Agati Clinical Informatics

Why Verisian

Improve Quality, Reduce Costs, Resources, and Time-to-Market

Specification Validation

Validate your SDTM and ADaM implementations variable-by-variable using full study traceability to ensure adherence to the study’s SAP and specifications.

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Results Validation

Validate your results, TLF-by-TLF, by reviewing the TLF, its data and relevant derivations using full study traceability to ensure correctness.

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Validation Tracker

Track and manage validation issues with full study traceability. Automatically link findings to the exact variable, dataset, or result, ensuring seamless communication, assignment, and resolution across teams.

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Data Explorer

Explore, review, and visualize your study data intuitively. Its integration with full traceability allows you to instantly inspect variable, track their transformations across datasets, and identify discrepancies with complete transparency from raw data to final outputs.

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Tracer

Trace your TLFs, data, and code with full study traceability. See data transformations and filter code to reveal essential derivations and results.

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Build

Build faster and higher quality studies through automation.

Easier code reuse across studies

Build SDTM, ADaM and TLF derivations faster using validated code extracted from previous studies.

AI co-pilot for clinical trials

Write better code for clinical trial analysis (including SDTM and ADaM), auto-generate documentation, and get help fixing bugs.

Develop and debug your code in confidence

See how datasets, variables, formats and codelists interact and understand upstream dependencies and downstream effects across your study.

Validate

Validate with Verisian to increase quality and speed while saving costs and resources.

Guarantee the quality of your analyses

Validate your SDTM and ADaM implementations variable-by-variable using full study traceability to ensure adherence to the study’s SAP and specifications

Validate data and results

Validate your results, TLF-by-TLF, by reviewing the TLF, its data and relevant derivations using full study traceability to ensure correctness

Eliminate Double Programming

Use the Validated by Verisian process to raise quality, gain confidence, and eliminate double programming to save cost, resources, and time

Submit

Submit transparently with quality, consistency, and confidence using Verisian Augmented Submissions.

Use full traceability for define.xml automation

Automatically generate, update, and ensure consistency for SDTM, ADaM, and ARM define.xmls to be always submission-ready

Generate first drafts of submission documents

Automatically generate first drafts of patient narratives and other submission documents using our proprietary study traceability-enabled AI system to speed up your submission workflow

Augmented submissions

Speed up review and prevent inquiries from regulatory authorities by augmenting your submission with Verisian. Grant regulatory access to full study traceability to speed up review, build trust, and get approval faster

In the spotlight

Join the Verisian Community

Join any of our meetups around the world to connect in-person, or join our online community for virtual peer support and updates.

Join the community

The Future of Validation in Clinical Trial Analysis

Trusted by Industry Leaders

Improve Quality, Reduce Costs, Resources, and Time-to-Market

Specification Validation

Results Validation

Validation Tracker

Data Explorer

Tracer

Build

Validate

Submit

In the spotlight

Traceability and AI for Better Understanding, Communication, and QC of Trials

Introducing Variable Traceability

Metadata Automation is Failing: A Paradigm Shift is Coming

Join the Verisian Community