Our team has extensive experience in providing a wide range of statistical services.
These statistical services include the key processes outlined below.
The study design process covers elements such as sample size calculation, endpoint definitions and statistical methodology. Discussion of these elements occurs within the clinical project team at the earliest possible stage of protocol development.
STATISTICAL ANALYSIS PLANS
Statistical analysis plans are produced during the clinical phase and include patient populations, parameters for analysis and primary and secondary endpoints. In addition all statistical methodology is incorporated into the statistical analysis plan from the protocol.
CLINICAL DATA REVIEW
A full data review is carried out by our clinical team of doctors, statisticians and project managers. Primary efficacy parameters and standard safety data are reviewed during this process. Subject populations are also drawn up, along with listings of protocol violators.
PROJECT PROGRAMMING AND DATA TABULATIONS
Standard and study specific safety and efficacy tabulations are designed and programmed well in advance of database lock. This ensures preliminary results are reported to the client within days of randomisation code release. Data summaries are in-line with ICH requirements outlined in E3, structure and content of clinical study reports.
STATISTICAL ANALYSES AND REPORTING
The quality controlled statistical analyses are prepared by our statisticians. The collation of the protocol, statistical analysis, data listings and summary tables are prepared by our report writers with advice from our statisticians and doctors. Finally, our internal independent reviewers ensure the draft and final reports are produced to the highest possible standards.