Statistical Analysis

A clear and detailed analysis plan is drafted prior to treatment unblinding in blinded trials or prior to collecting patient data in open trials. This plan defines the primary and secondary endpoints, assumptions made, conventions used to derive new data and to estimate missing data, statistical analysis techniques, and lists all Tables, Figures and Listings to be produced.

Veeda CR has analyzed data from all stages of clinical development (pre-clinical, clinical: Phase I, including classical and population PK/PD analysis, to Phase IV, and epidemiological trials), with a variety of designs (parallel group, cross-over, factorial) and statistical hypotheses (superiority, non-inferiority, equivalence, bio-equivalence), including interim analyses using adaptive designs, sequential designs, and sample size adjustment designs. Biometric staff of Veeda CR has been involved in Independent Data Monitoring Committees to assist in the decision-making process or to offer statistical support independent from the sponsor.

Statistical analysis is performed using SAS and StatXact. For PK/PD analysis WinNonLin is used. Veeda CR has the expertise to produce specific TFLs using SAS reporting. At Veeda CR our aim is to ensure that the client receives the data in the exact format required. In order to provide this service our biometrics team is involved early in the study discussions.