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One live review workspace
Clinical, statistics, medical writing, and leadership all review the same live outputs , no mismatched PDFs.
CLYMBR HUB · TFL & CSRTFL Viewer ™ +
CSR Builder ™
Review, approve, and assemble TFL outputs into a submission-ready Clinical Study Report , all from one source of truth.
TFL Viewer + CSR Builder is a unified Clymbr Hub module for clinical output review and CSR authoring. Reviewers compare TFL versions, drill into Analysis Results Data, and approve outputs with e-signature; approved results then flow directly into structured, GenAI-assisted Clinical Study Report sections so every number in the report is linked to its source.
- ARD-native TFL review with cross-version comparison
- Structured review comments and electronic signatures
- Automated in-text table generation from approved results
- Live integration with TFL Viewer , writers always have the latest approved outputs
TFL Viewer + CSR Builder , in the workflow— / 04
upstream
Structured Analysis Results Data underpins every number that reaches review.
70–80%
Cost reduction in review time
In-text table generation
In-text summary tables generated automatically from approved TFLs and their ARD , correctly formatted and placed in the CSR section.
25–35%
Cost reduction per study CSR
Capabilities
What TFL Viewer + CSR Builder does
A controlled workspace where every stakeholder reviews the same outputs, then approved results flow directly into the Clinical Study Report.
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ARD-native drill-down
Every number is backed by Analysis Results Data, so reviewers can trace a cell back to the result that produced it.
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Version and cross-study comparison
Diff outputs across drafts, data cuts, populations, and even studies to see exactly what changed.
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Controlled approval
Capture reviewer decisions and electronic signatures against a specific version of a specific output.
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ICH E3-aligned CSR templates
Start from structured, reusable report templates that encode your sponsor conventions and section structure.
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Automated in-text table generation
In-text summary tables are generated directly from approved TFLs and their ARD , no copy-paste, no re-formatting, no stale numbers.
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Live TFL Viewer integration
CSR Builder is wired straight into TFL Viewer, so medical writing always works from the latest approved version of every output.
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GenAI-assisted drafting
Generate first-draft narrative for standard sections directly from the results, with the writer in control.
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Numbers that stay consistent
In-text values are bound to the ARD, so a re-approved output updates the report rather than leaving a stale figure.
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Broad document coverage
The same engine supports CSR, ISS/ISE, annual reports, Investigator's Brochure, and DSUR content.
How it works
TFL Viewer + CSR Builder in the workflow
From generated outputs to a submission-ready CSR, without re-keying a single number.
Publish the draft
Outputs generated against approved shells are published into the viewer as a controlled draft.
Review in context
Reviewers compare versions, drill into ARD, and leave comments directly against the output.
Resolve and re-run
Programmers action comments, re-run, and the viewer shows exactly what changed between versions.
Approve and release
Sign off each output electronically; approved results become available to CSR Builder.
Assemble the CSR
Approved TFLs and ARD are inserted into ICH E3-aligned sections; GenAI drafts narrative and writers refine.
Review and export
Run structured CSR review, capture sign-off, and export a submission-ready document.
Key functionalities
Everything included in TFL Viewer + CSR Builder
TFL Viewer streamlines review, feedback and approval of tables, figures and listings , and CSR Builder bolts on to draft CSR sections from those same machine-readable outputs using large language models.
12 capabilities shipped today
Platform
Secure cloud-based, scalable solution
Hosted in Clymb's validated SCE with role-based access, encryption and elastic compute , handles full study output sets without local installs.
Select any capability to see what it does.
Standards & compliance
Built to the standards your submission expects
- CDISC ARS
- Analysis Results Data (ARD)
- ARD JSON
- ICH E3
- eCTD-ready outputs
- 21 CFR Part 11
- GxP
Who uses it
Teams working in the same workspace
- Biostatisticians
- Statistical programmers
- Medical writers
- Clinical scientists
- Regulatory affairs
- CRO / partner reviewers
- Submission leads
Common questions
About TFL Viewer + CSR Builder
What is TFL Viewer + CSR Builder?+
It is a combined Clymbr Hub module that closes the loop between TFL review and CSR authoring. Teams review and approve Tables, Figures, and Listings in a controlled workspace, then pull those approved outputs and their underlying Analysis Results Data straight into a structured Clinical Study Report.
What is ARD and why does it matter?+
ARD (Analysis Results Data) is a CDISC standard that captures analysis results as structured data rather than just formatted tables. TFL Viewer is ARD-native, so every number in an output can be traced back to the result that produced it , and that same data feeds CSR Builder.
How does review connect to CSR authoring?+
Approved TFLs and their ARD flow directly into CSR Builder. Medical writers use the exact signed-off numbers, and any re-approved output updates the report automatically, eliminating transcription errors.
Does CSR Builder replace medical writers?+
No. CSR Builder accelerates the mechanical parts of drafting , inserting the right tables, summarizing standard sections, keeping numbers consistent , so medical writers spend more time on interpretation and clinical narrative.
Which standards does it support?+
TFL Viewer + CSR Builder supports CDISC ARS/ARD, ICH E3, 21 CFR Part 11, GxP, and eCTD-ready outputs.
See TFL Viewer + CSR Builder inside Clymbr Hub.
Bring your team, your study, and your code. We'll show you TFL Viewer + CSR Builder working end-to-end alongside the rest of the platform.