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Biostatistics

Our Biostatisticians are involved in a broad range of activities, including:

  • Study design

  • Statistical Analysis Plan (SAP)

  • Sample size calculation

  • Statistical consideration inputs to study protocol

  • Randomization

  • Mock Shells

  • Interim Analysis (IA)

  • Data Safety Monitoring Boards (DSMBs)

  • PK Analysis

  • Statistical and strategic consulting

  • Programming & validation of TLFs

  • Support CDM to review and understand the data

  • Providing biostatisticians under FTE (Full Time Employee) module

  • Population Bioequivalence Study (PBE): Development of programming codes and setups at client site

  • Dissolution profile comparison using statistical methods model-independent, model-dependent, bootstrapping 

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Biostatistics is essential for all investigational drug product development to determine the efficacy and safety in clinical research. Biostatistics play an important role in study designs, determining the most relevant data end points and analysis and reporting.

At PHARMA-STATS, biostatistics is our hard-core services and solutions. Our skilled biostatisticians are involved to increase efficiencies at every phase of clinical drug development. We deliver clinical research results that are scientifically accurate, validated and reproducible. By using the appropriate tools, we are able to demonstrate the efficacy of a drug and present the results in the clearest way possible.

Experience with various therapeutic areas:

  • Anti-infective

  • Anti-Inflammatory, Pain Management

  • Cardiovascular

  • CNS

  • Dental

  • Dermatology

  • Endocrinology & Metabolic Disease

  • Gastroenterology

  • Hematology

  • Musculoskeletal, Rheumatology and Osteology

  • Nephrology, Renal, and Urology

  • Oncology

  • Ophthalmology

  • Respiratory

  • Vaccine & Virology

  • and many more....