R-Based Clinical Trial Submission

Replace SAS with R
for Regulatory Submissions

End-to-end R submission pipeline — from SDTM to ADaM to TLFs — built for compliance, verifiability, and regulatory acceptance.

端到端R语言临床试验递交方案。合规、可验证、监管可接受 — 背靠MNC端到端R递交经验。

01

available

aCRF Annotation

Automated aCRF Annotation from CRF PDF + SDTM Mapping

上传空白CRF + SDTM映射表,一键生成监管级aCRF

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02

available

SDTM Recommendation

Intelligent SDTM Variable Mapping Suggestions

智能SDTM变量映射推荐,加速标准化决策

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03

available

Dual Bookmark

Dual-Layer PDF Bookmarks for aCRF Navigation

aCRF PDF双层书签:按SDTM域 + 按访视,一键导航

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04

planned

Define.xml Generator

Auto-Generate CDISC Define.xml from Dataset Metadata

从数据集元数据自动生成CDISC Define.xml — 每次递交必做

05

planned

Data Concordance Check

EDC vs. Electronic Source Data Discrepancy Detection

EDC与电子源数据一致性核查

06

planned

End-to-End R Submission

Compliant, Verifiable, Regulatory-Accepted R Submission

合规、可验证、监管可接受的端到端R递交方案

StandardizationAnnotationConcordanceSubmission