End-to-End Statistical Leadership
From protocol design through post-submission support, providing strategic expertise with proven regulatory success
What we can do
Full-Spectrum Programming Excellence
Regulatory-ready SDTM/ADaM datasets, validated TFL programming, and submission-quality deliverables meeting regulatory standards
Regulatory Submission Mastery
NDA/BLA statistical packages including eCTD Module 5, ISS/ISE integration, and comprehensive CSR development
Strategic Trial & Publication Support
IDMC/DSMB statistics, adaptive design implementation, manuscript preparation, and post-approval analytics
Regulatory-Grade Biostatistics from Protocol to Approval
End-to-end biostatistics & statistical programming excellence powered by AI automation, delivering regulatory-ready datasets and analyses with 40% faster turnaround through validated excellence from protocol to submission.
What we offer
Stage 1: Study Planning
- Statistical Section of Protocol
- Sample size justification & power analysis
- Randomization
- Statistical Analysis Plan (SAP) with mock shells
Stage 2: Trial Execution
- SDTM/ADaM/TFL
- IDMC/DSMB management
- Safety monitoring reports
Stage 3: Final Analysis
- Final complete SDTM/ADaM/TFL package
- Statistical analysis report
- CSR statistical sections
Stage 4: Submission Ready
- ISS/ISE integrated analysis
- Regulatory inspection-ready documentation
- eCTD Module 5 components
Quality Guaranteed
- Full validation
- Regulatory compliance
- Complete documentation
Service category 1Biostatistics Services
- Protocol statistical design & consultation
- Database Build & Configuration
- Statistical methodology selection
- Adaptive design planning
- Statistical Analysis Plan (SAP) development
- Randomization & blinding strategies
Service category 2Statistical Programming
- CDISC SDTM/ADaM programming
- TFL generation & validation
- Custom analysis programming
- Legacy data conversion
- Define.xml & metadata creation
- Programming automation & macros
Service category 3Clinical Trial Support
- IDMC/DSMB statistical support
- Interim analysis & safety monitoring
- Central statistical monitoring
- Real-time data review
- Safety signal detection
- Blinded data management
Service category 4Regulatory Services
- NDA/BLA statistical submissions
- ISS/ISE integration
- Regulatory response support
- ADCOM/ODAC preparation
- CSR statistical sections
- Regulatory strategy consulting
Service category 5Publication & Dissemination
- Manuscript statistical review
- Conference abstract development
- Post-marketing analysis
- Real-world evidence studies
- Meta-analysis support
- Scientific communication
How We Engage
A streamlined 4-step approach to clinical excellence.
1
Strategic Planning & Design
Week 1-3
- Resource allocation & timeline planning
- Protocol statistical review & optimization
- Sample size calculation & power analysis
- SAP development with mock shells
- Regulatory strategy alignment
2
Programming Setup
Week 3-6
- SDTM/ADaM specifications development
- Programming standards & environment setup
- Mock TFL programming
- Validation & QC strategy
- Data transfer specifications
3
Trial Execution
Ongoing
- IDMC/DSMB statistical packages
- Safety monitoring & reporting
- Interim analysis support
- Real-time issue resolution
4
Final Analysis
Week 1-4 Post-Lock
- Final SDTM/ADaM/TFL
- Statistical analysis execution
- Independent double programming
- Comprehensive QC & validation
5
Submission Assembly
Week 5-8 Post-Lock
- ISS/ISE integration
- eCTD Module 5 compilation
- Regulatory compliance check
6
Post-Submission Support
Ongoing
- Regulatory query responses (48hr SLA)
- Additional analyses as requested
- ADCOM/ODAC support
- Publication assistance
Ready to optimize your clinical trial?
Accelerating Drug Development with Data-Driven Biometrics & Clinical Intelligence.
Submit RFP Biostatistics & Programming
Regulatory-Grade Biostatistics from Protocol to Approval
Get in Touch What we can do
End-to-End Statistical Leadership
From protocol design through post-submission support, providing strategic expertise with proven regulatory success
Full-Spectrum Programming Excellence
Regulatory-ready SDTM/ADaM datasets, validated TFL programming, and submission-quality deliverables meeting regulatory standards
Regulatory Submission Mastery
NDA/BLA statistical packages including eCTD Module 5, ISS/ISE integration, and comprehensive CSR development
Strategic Trial & Publication Support
IDMC/DSMB statistics, adaptive design implementation, manuscript preparation, and post-approval analytics
Regulatory-Grade Biostatistics from Protocol to Approval
End-to-end biostatistics & statistical programming excellence powered by AI automation, delivering regulatory-ready datasets and analyses with 40% faster turnaround through validated excellence from protocol to submission.
What we offer
Stage 1: Study Planning
- Statistical Section of Protocol
- Sample size justification & power analysis
- Randomization
- Statistical Analysis Plan (SAP) with mock shells
Stage 2: Trial Execution
- SDTM/ADaM/TFL
- IDMC/DSMB management
- Safety monitoring reports
Stage 3: Final Analysis
- Final complete SDTM/ADaM/TFL package
- Statistical analysis report
- CSR statistical sections
Stage 4: Submission Ready
- ISS/ISE integrated analysis
- Regulatory inspection-ready documentation
- eCTD Module 5 components
Quality Guaranteed
- Full validation
- Regulatory compliance
- Complete documentation
Service category 1
Biostatistics Services
- Protocol statistical design & consultation
- Database Build & Configuration
- Statistical methodology selection
- Adaptive design planning
- Statistical Analysis Plan (SAP) development
- Randomization & blinding strategies
Service category 2
Statistical Programming
- CDISC SDTM/ADaM programming
- TFL generation & validation
- Custom analysis programming
- Legacy data conversion
- Define.xml & metadata creation
- Programming automation & macros
Service category 3
Clinical Trial Support
- IDMC/DSMB statistical support
- Interim analysis & safety monitoring
- Central statistical monitoring
- Real-time data review
- Safety signal detection
- Blinded data management
Service category 4
Regulatory Services
- NDA/BLA statistical submissions
- ISS/ISE integration
- Regulatory response support
- ADCOM/ODAC preparation
- CSR statistical sections
- Regulatory strategy consulting
Service category 5
Publication & Dissemination
- Manuscript statistical review
- Conference abstract development
- Post-marketing analysis
- Real-world evidence studies
- Meta-analysis support
- Scientific communication
How We Engage
A streamlined 4-step approach to clinical excellence.
1
Strategic Planning & Design
Week 1-3
- Resource allocation & timeline planning
- Protocol statistical review & optimization
- Sample size calculation & power analysis
- SAP development with mock shells
- Regulatory strategy alignment
2
Programming Setup
Week 3-6
- SDTM/ADaM specifications development
- Programming standards & environment setup
- Mock TFL programming
- Validation & QC strategy
- Data transfer specifications
3
Trial Execution
Ongoing
- IDMC/DSMB statistical packages
- Safety monitoring & reporting
- Interim analysis support
- Real-time issue resolution
4
Final Analysis
Week 1-4 Post-Lock
- Final SDTM/ADaM/TFL
- Statistical analysis execution
- Independent double programming
- Comprehensive QC & validation
5
Submission Assembly
Week 5-8 Post-Lock
- ISS/ISE integration
- eCTD Module 5 compilation
- Regulatory compliance check
6
Post-Submission Support
Ongoing
- Regulatory query responses (48hr SLA)
- Additional analyses as requested
- ADCOM/ODAC support
- Publication assistance
Ready to optimize your clinical trial?
Accelerating Drug Development with Data-Driven Biometrics & Clinical Intelligence.
Submit RFP