CLINNEX has been involved in the analysis of data from all stages of clinical development with a variety of designs and statistical hypotheses, including interim analyses using adaptive, sequential, and sample size adjustment designs.
We have been involved in Independent Data Monitoring Committees to assist in decision-making process or to offer statistical support independent from the sponsor.
The Statistical Analysis Services Offered by Clinnex include:
- Sample size calculation
- Statistical inputs in the protocol
- Statistical analysis plan
- Interim analysis
- Tables, listings, figures
- Statistical report
- CDISC Data submission for USFDA