Biostatistics Services

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Biostatistics Service
Customized end-to-end biostatistics services covering the full lifecycle of clinical research
Full-Cycle Biostatistics Services: Intelligence-Driven, Precision Decision-MakingClinflash leverages its team of seasoned statistical experts and AI digital platforms to provide sponsors and CROs with full-cycle biostatistics services. We strictly adhere to CDISC international standards, utilizing 15 core SOPs and an intelligent quality control system to ensure data reliability throughout the entire lifecycle, from trial design to results submission. By deeply integrating AI algorithms with traditional statistical models, we achieve efficient and accurate variable identification and risk prediction. This significantly enhances analytical efficiency and decision-making quality, delivering robust statistical support for clinical development and accelerating the transformation of innovative outcomes.
Providing End-to-End Biostatistics Services from Protocol Design to Statistical Reporting
Biostatistics
Clinical Trial Design & ConsultingTables, Figures, and Listings TemplatesAdaptive Design PlanningPK/PD Statistical AnalysisIntegrated Safety & Efficacy Analysis (ISS/ISE)Statistical Analysis Plan (SAP) DevelopmentStatistical Support for Sponsor-Regulatory CommunicationsSample Size CalculationStatistical Analysis Report (SAR) Writing & ReviewInterim Analysis/DMC Statistical SupportCentralized Monitoring/RBM ImplementationRandomization Scheme Development & Blinding ImplementationProtocol & Report Statistical Support
Statistical Programming
CDISC-Compliant Submission Datasets & Documentation: aCRF, SDTM, ADaM, Define.xml, Reviewer's GuideAnalyse the datasetData Monitoring Committee (DMC), Evaluation Committee, and Interim Analysis ResultsISE/ISS statistical programmingTable，Figure，Listing（TFLs）Generation & ValidationRapid Response to Regulatory QueriesJournal Publication & Post Hoc AnalysisExploratory Analysis Outputs
Providing End-to-End Biostatistics Services from Protocol Design to Statistical Reporting
Biostatistics
Clinical Trial Design & Consulting
Tables, Figures, and Listings Templates
Adaptive Design Planning
PK/PD Statistical Analysis
Integrated Safety & Efficacy Analysis (ISS/ISE)
Statistical Analysis Plan (SAP) Development
Statistical Support for Sponsor-Regulatory Communications
Sample Size Calculation
Statistical Analysis Report (SAR) Writing & Review
Interim Analysis/DMC Statistical Support
Centralized Monitoring/RBM Implementation
Randomization Scheme Development & Blinding Implementation
Protocol & Report Statistical Support
Statistical Programming
CDISC-Compliant Submission Datasets & Documentation: aCRF, SDTM, ADaM, Define.xml, Reviewer's Guide
Analyse the dataset
Data Monitoring Committee (DMC), Evaluation Committee, and Interim Analysis Results
ISE/ISS statistical programming
Table，Figure，Listing（TFLs）Generation & Validation
Rapid Response to Regulatory Queries
Journal Publication & Post Hoc Analysis
Exploratory Analysis Outputs
Core Advantages
Expert Team + AI Platform
Led by senior biostatisticians with intelligent algorithms for high-precision statistical analysis
Extensive project experience across Phase I-IV studies
End-to-End Service
Full cycle support covering trial design, statistical analysis to report submission
Statistical analysis process based on extensive project experience
International Standards
Strict compliance with CDISC standards
12 core SOPs ensuring data reliability and traceability
Intelligent Efficiency
AI-powered variable identification & risk alerts improving analysis efficiency by 30%+
Dual SAS programming and quality control systems
Core Advantages
Expert Team + AI Platform
Led by senior biostatisticians with intelligent algorithms for high-precision statistical analysis
Extensive project experience across Phase I-IV studies
End-to-End Service
Full cycle support covering trial design, statistical analysis to report submission
Statistical analysis process based on extensive project experience
International Standards
Strict compliance with CDISC standards
12 core SOPs ensuring data reliability and traceability
Intelligent Efficiency
AI-powered variable identification & risk alerts improving analysis efficiency by 30%+
Dual SAS programming and quality control systems
Full Compliance with CDISC Standards
Full Compliance with CDISC Standards
Service Coverage Areas
Oncology
Hematology
Respiratory
Women's Health
Ophthalmology
Nephrology & Urology
Neurology
Dermatology
Immunology
Endocrinology
Service Coverage Areas
Oncology
Hematology
Respiratory
Women's Health
Ophthalmology
Nephrology & Urology
Neurology
Dermatology
Immunology
Endocrinology
Clinflash IRT
Clinflash EDC
IRT/RTSM
System Configuration And Management Services
The leading provider of digital solutions and professional services in field of clinical development
Company Hotline：400-803-8655
Business Cooperation：bd@clinflash.com
Technical Support：edchelp@clinflash.com
Jiaxing Office：3rd Floor, Building 3, No. 551 Yazhong Road, Nanhu District, China PRC
Shanghai Office：Room 813, 999 West Zhongshan Road, Huawen Plaza, Shanghai, 200051, P/R. China
Hangzhou Office：16/F, Block A, Shanda Technology Park, No. 19 Jugong Road, Binjiang District, Hangzhou
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Zhejiang ICP 15024529-3Copyright © 2026 Clinflash International Limited. All Rights ReservedZhejiang Public Network Security 33040202000550Privacy PolicyService Levels (SLA)System Node Policy
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The leading provider of digital solutions and professional services in field of clinical developmentCompany Hotline：400-803-8655Business Cooperation：bd@clinflash.comTechnical Support：edchelp@clinflash.comJiaxing Office：3rd Floor, Building 3, No. 551 Yazhong Road, Nanhu District, China PRCShanghai Office：Room 813, 999 West Zhongshan Road, Huawen Plaza, Shanghai, 200051, P/R. ChinaHangzhou Office：16/F, Block A, Shanda Technology Park, No. 19 Jugong Road, Binjiang District, Hangzhou
Clinflash official account
Privacy PolicyService Levels (SLA)
Zhejiang ICP 15024529-3Copyright © 2026 Clinflash International Limited. All Rights ReservedZhejiang Public Network Security 33040202000550
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