CSR Builder
CSR Builder is a web-based authoring platform designed to streamline the drafting, review, and maintenance of Clinical Study Reports across clinical programs.
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Narrative Generation
Automatically generate results narratives directly from tables, figures, and listings viewed in TFL Viewer. CSR Builder ensures that text accurately reflects the underlying data, reducing transcription errors and speeding up results writing.
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Intelligent Section Authoring
Create standardized, high-quality narratives for key CSR sections—such as Efficacy, Safety, Disposition, and Demographics—with configurable sponsor style, tone, and regulatory conventions, while preserving full editorial control.
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Dynamic Updates & Change Propagation
When outputs change, CSR Builder helps identify impacted sections and supports rapid narrative updates—minimizing manual rework during late-stage data refreshes or re-runs.
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Traceability & Auditability
Maintain a clear link between narratives, source TFLs, and SAP specifications. Built-in traceability supports internal review, quality checks, and regulatory inspection readiness.
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Export Functionalities
Export CSRs to Word or PDF formats with controlled formatting and versioning, supporting submission-ready deliverables while maintaining a complete audit trail.
Why CSR Builder?
CSR Builder is a centralized, web-based solution that supports end-to-end CSR authoring from first draft through final submission. By leveraging structured inputs such as TFLs, SAPs, and metadata, CSR Builder ensures consistency, traceability, and efficiency across every section f the report.
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75%
Reduction in overall CSR authoring time
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ICH E3 Aligned
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50%
Cost reduction in report generation process
Experience the power of CSR Builder
Contact the Clymb team to schedule a demo of our CSR Builder solution and learn more about our community and enterprise-level offerings.