CROS NT has an expert team of biostatisticians with a range of experience, from the planning and design of a trial, to reporting and regulatory submission guidance. It is generally agreed that the best time to involve a biostatistician in a clinical study is at its inception. This allows the biostatistician to understand the study design and make suggestions on hypothesis testing and analysis and also ensures continuity throughout the study team.
CROS NT has performed statistical analysis and reporting activities for thousands of studies in a variety of therapeutic areas, in all phases of drug development and medical device trials.
Our biostatisticians deliver the following services:
- Study Design and complex study design including Adaptive and Bayesian
- Power/sample size calculations
- Protocol Writing and Review
- CRF Design & Review
- Statistical Analysis Plan
- Production and Validation of Interim Analysis and Reports
- Ad hoc analyses
- Preparation of Integrated Summaries of Safety & Efficacy
- Filing and Reporting with Regulatory Bodies (FDA and EMA)
- Statistical Analysis Reports including the statistical analysis part of the Clinical Study Report
- Centralized Statistical Intelligence to facilitate Risk-Based Monitoring