The driving force of biostatistics gives the investigational product story, demonstrating the efficacy and safety analysis of the drug. Our teams with sound and deep knowledge in statistics unveil their potential in complex areas of study design, sample size calculation, analysis methods and interpretations. Stark Associates provides the services understanding the global regulatory requirements and guidelines.
- SAS software
- Statistical inputs for development study protocol
- Preparation of Statistical analysis plans for traditional as well as adaptive clinical trials
- Randomization, Power calculation with defined sample size and Interim analysis
- Designing and development of tables, graphs and listings
- Recommendation / evaluations on study design and regulatory submissions
- Interim analysis support for adaptive clinical trials
- Expert personnel to serve as statisticians on Data Monitoring Committees
- Analysis datasets and integrated database in CDISC format (ADaM) thereby fulfilling electronic submission requirements
- Statistical sections clinical technical document integrated summaries of safety and efficacy
- Statistical support for presentations and publications
