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

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

Dental

Dermatology

Endocrinology & Metabolic Disease

Gastroenterology

Hematology

Musculoskeletal, Rheumatology and Osteology

Nephrology, Renal, and Urology

Oncology

Ophthalmology

Respiratory

Vaccine & Virology
and many more....