Products

R Submission Pipeline — From SDTM to TLF

A unified product suite organized around the clinical submission workflow. Available tools ship today; planned tools reflect our R-first roadmap.

围绕临床递交流水线组织的统一产品套件。已上线工具可直接使用，规划中工具反映我们的R优先路线图。

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aCRF generation after SDTM mapping / Clinical trial data submission (FDA/NMPA) / Automatic CRF-to-SDTM domain correspondence / Annotation quality QC with audit logs

aCRF Annotation

available

Upload a blank CRF PDF and SDTM mapping Excel, get an FDA/NMPA/EMA-compliant annotated CRF in minutes. Uses fuzzy matching to locate PDF fields, intelligently places SDTM domain/variable annotation boxes, supports multi-domain splitting and conditional annotations.

Upload CRF PDF + SDTM mapping Excel, one-click aCRF generation4-step fuzzy matching (exact → normalized → fuzzy → form context)Color-coded annotation boxes by SDTM domain, dashed borders for derived variablesAuto multi-domain row splitting, conditional annotation (when/then) parsingOverlap detection and smart position adjustment (up to 20 attempts)Complete processing log (match status, scores, page numbers, warnings)

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SDTM standardization for eCRF data

SDTM Recommendation

available

Accelerates SDTM mapping decisions for clinical data programmers. Provides structured variable-level recommendations grounded in clinical domain knowledge — the first step in every R-based submission pipeline.

Structured variable recommendationClinical domain context

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Quickly navigate large CRF documents by domain and visit / Preparing regulatory submission documents

Dual Bookmark

available

Adds dual-layer bookmark navigation to completed aCRF PDFs: organized by both SDTM domain and clinical visit. No SDTM mapping table required — just fill in page-to-visit correspondence.

Auto-extracts PDF page text, generates configuration tableDomain + Visit dual-layer bookmark structureNo SDTM mapping table required, standalone usageSupports Adobe Acrobat, Foxit, and other PDF readers

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Planned

Define.xml generation for every regulatory submission

Define.xml Generator

planned

Automatically generates CDISC-compliant Define.xml from SDTM/ADaM dataset metadata. Pure rule-driven, high standardization — the most immediate revenue opportunity in every submission package.

CDISC Define.xml 2.1 complianceAuto-derive ODM metadata from datasets

Source-to-EDC concordance review

Data Concordance Check

planned

Detects discrepancies and inconsistencies between EDC data and electronic medical records / electronic source data. A critical QC step before submission.

Discrepancy detectionSource-to-EDC audit

Complete R-based regulatory submission

End-to-End R Submission

planned

Complete clinical submission workflow built on R — from SDTM to ADaM to TLFs. Emphasizes compliance, verifiability, and regulatory acceptance. Backed by real MNC end-to-end R submission experience.

Compliance-first workflowVerifiable delivery with audit trailDual-programming independent QC