PointCross 为临床、生物标志物、非临床、临床前检测以及其他相关辅助检测提供数据标准化服务。我们的数据标准化团队开发各类工具、工作流程、智能工具和自动化系统,将原始源数据整理为标准数据模型(如 ODM 或通用数据模型),用以支持直接分析或派生元数据的生成。我们还提供自动化工具,将数据从标准数据模型转换为监管提交标准,例如 SDTM、ADaM、SEND 或 CDISC 及相关机构发布的其他标准,并严格遵循 CDISC、FDA、PMDA 制定的规则。
- About
- SOLUTIONS
- SEND Services
- Interim Study Monitoring
- Digital Study Report (DSR) GenerationAuto-generate compliant study reports from your data
- Automated SDTM Generation from EDCConvert EDC data to SDTM-ready datasets automatically
- Biosample Tracking for Specialty AssaysTrack and manage biosamples across specialty & translational assays
- Clinical or Nonclinical RepositoryCentralized repository to store, search & visualize study data
- PRODUCTS
- XBIOM™ Solutions PlatformEnd-to-end platform for clinical & nonclinical data automation
- Single Track ProcessingDeliver Study Reports + SEND submissions in 2–3 weeks
- XBIOM™ VDR, Study Data I/O, CurationSecurely exchange, organize & curate study data in one place
- XBIOM™ MDR, Smart Transformer, eDVTransform and standardize metadata for regulatory-ready submissions
- XBIOM™ UDM, RepositoryStore all study data in a unified, analysis-ready repository
- XBIOM™ Regulatory SubmissionPackage and submit SDTM, ADaM & TFLs for regulatory agencies
- XBIOM™ Nonclinical InsightsAnalyze and compare data across nonclinical studies
- XBIOM™ Clinical InsightsRun cohort analyses and build statistical analysis plans
- eDataValidatorValidate SDTM, ADaM & SEND datasets against CDISC standards
- XBIOM™ IGO - Immersive Graphics Object for TFL generationGenerate publication-quality Tables, Figures & Listings (TFLs)
- Services
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