Biostatistics and Statistical Programming

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Biostatistics and Statistical Programming

Right from strategies to operations to protocol design to final analysis, Cispact’s Biostatistics and Statistical Programming stands by you through every phase. Our services are catered across a wide range of therapeutic areas complying with the local and global regulatory agencies for a successful acceptance of a therapy. We at Cispact are a house to a highly skilled team of Statisticians and Clinical SAS Programmers who master the knowledge of global regulatory requirements and guidelines. With an extraordinary team of leaders who specialize in leading industry technology, we help you generate high-quality standardised deliverables much ahead of the designated deadlines.

Biostatistical Services

  • Clinical study design & sample size calculations
  • Number of studies & randomization methodology/schemes
  • Protocol Development and strategic consultancy advice
  • Delineation of objectives and endpoints
  • Statistical analysis plans (SAP) composition, mock shells creation and reports
  • Plan development, schedule generation, review and implementation for randomization
  • Clinical trial planning, stimulation and implementation through adaptive design
  • Generation of ADaM (Analysis Data Model)
  • Blinded and Unblinded Tables, Listings and Figures (TLF) review and results interpretation
  • PK/PD Analyses
  • Integrated safety and efficacy analyses (ISS/ISE/ISM)
  • Support and consultancy services for Data and Safety Monitoring Board (DSMB), DMC and Interim analysis
  • Submissions management & regulations.

Statistical Programming Services

  • TLF’s - Generation of Tables, Listings and Figures as per Statistical Analysis Plan And Quality Control
  • CDISC SDTM Mapping and Conversion
  • Generation of ADaM (Analysis Data Model) & Interim Analysis Support
  • Observational study analysis
  • CDISC and ADaM Submission-ready Dataset Development and Quality Control for Submission Compliance
  • Analysis Dataset Development and Quality Control for ISS and ISE
  • Annual Clinical Trial Safety Updates

" We promise statistical experience and robust programming towards quality control and best trials through preclinical, clinical, registration, and post-marketing phases of trials "