Differentiators
Proficency
15+ years of experience in the field of Biostatistics services
330+ projects executed
All phase of clinical trials, Non-Interventional Studies (NIS), FMCG and Real World Evidence (RWE)
Our core expertise
Statistical input to study protocol, design, DSMB/DMC, Interim Analysis, Statistical Analysis Plan (SAP) Randomization
SAS programmers with wide therapeutic area experience along with Statistical Programming services
Compliance and Quality assurance
Compliance with current industry standards and regulatory guidelines/ requirements
High quality biostatistics deliverables
CDISC Submission Format
Adaptability and efficiency to comply with CDISC format
Biostatistics and Programming service offerings
Biostatistical Services
- Statistical inputs to control
- Sample size estimation
- Randomization for open label and blinded studies
- SAP develoment
- Statistical analysis for trial data
- Support for DSMB/Interim Analysis/BDR activities
- Full DMC support, including preparation of the DMC charter
- PK and PD Analysis
- Interpretation of results and input to clinical study reports
Statistical Programming
- Writing SAS edit checks for data validation
- Programming analysis datasets
- Reporting of statistical analysis results (TLFs)
- Programming of CDISC deliverables
CDISC Programming/Legacy Data Conversion
- CRF annotation
- SDTM and ADaM specification creation
- Programming of SDTM and ADaM datasets
- Generation of define.xml
- CDISC complaint deliverables
Business Intelligence & Data Analytics
- Pharmaceutical sales analytics
- Supply chain analytics
- Risk based monitoring
- Dashboard reporting