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

  • Protocol Inputs Including Clinical Study Design, Sample Size Calculations, Number of Studies,
    Randomization Methodology and Consultancy Advice.
  • Delineation of Objectives and Endpoints and Analysis Strategies.
  • Randomization Plan Development, Schedule Generation, Review and Implementation.
  • Generation of ADaM (Analysis Data Model).
  • Blinded and Unblinded Tables, Listings and Figures (TLF) Review and Results Interpretation.
  • Statistical Analysis Plan (SAP) Composition and Mock Shells Creation.
  • PK/PD Analyses.
  • Support and Provide Consultancy for Data and Safety Monitoring Board (DSMB), DMC and
    Interim Analysis.
  • Submission.
  • Exploratory Analysis for Publications, Abstracts, and Marketing and Also A Meta-Analysis.

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) 

  • Observational study analysis

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