Biostatistics & Programming

Our biostatisticians offer extensive experience across all phases of clinical trials (Phase I-IV) and a broad range of therapeutic areas. Working closely with other departments, they ensure seamless integration and interpretation of statistical data for reporting and analysis.

Differentiators

Proficency

15+ years of experience in the field of Biostatistics and Programming 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 & 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

Why Choose Our
Biostatistics & Programming Services?

Biostatistical Services

Statistical inputs to control
Sample size estimation
Randomization for open label and blinded studies
SAP development
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