ScinoRx provides leading statistical and analytical services in support of clinical trials, regulatory submissions, marketing efforts, and quality initiatives. Our skillful resources apply innovative statistical methodologies to assess efficacy and safety analysis of the drug. Our principal focus is to provide our client with potential service with the abilities in complex areas of study design, concept protocols and data analysis strategy, sample size calculation, analysis methods and interpretations. ScinoRx provides the services understanding the global regulatory requirements and guidelines.
- SAS software
- Provides statistical plans for all phases of clinical studies
- Statistical inputs for development study protocol
- Reviews clinical study protocols and Case Report Forms (CRFs) for proposed studies
- 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
- Participate in pre IND and NDA activities
- Expert personnel to serve as statisticians on Data Monitoring Committees
- Analysis datasets and integrated database in CDISC format (ADaM) thereby fulfilling electronic submission requirements
- Assesses protocol deviations to the extent that they affect statistical analyses.
- Statistical sections clinical technical document integrated summaries of safety and efficacy
- Statistical support for presentations and publications