Solutions
Products Organized by Submission Workflow
From raw clinical data to regulatory submission package — each stage maps to dedicated tools in the Thynexa pipeline.
从原始临床数据到监管递交包——每个阶段对应Thynexa管线中的专用工具。
Workflow Stage
Standardization
Supporting standardized structure judgment and mapping suggestions to help organize clinical data standardization paths faster.
SDTM Recommendation
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.
Workflow Stage
Annotation
Supporting annotation expression and structured output, building reusable capabilities around the aCRF annotation workflow.
aCRF Annotation
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.
Dual Bookmark
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.
Workflow Stage
Concordance
Focusing on discrepancy checking between EDC and electronic source records, targeting subsequent QC and consistency review.
Data Concordance Check
Detects discrepancies and inconsistencies between EDC data and electronic medical records / electronic source data. A critical QC step before submission.
Workflow Stage
Submission
Focusing on compliant, verifiable, regulatory-driven delivery workflows, building a more robust R submission solution.
Define.xml Generator
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.
End-to-End R Submission
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.