Clinical statistics and database programming
Kinesis has specialists in SAS programming and data management, and
dedicated statisticians to fulfill the needs for efficacy and biomarker
analysis (especially in phase II, proof of concept type of studies), and
safety and demographic analysis.
All statistical and programming activities are performed in-line with the Regulatory requirements (ICH-GXP/Federal/Local).
Statistics
During
clinical trial planning Kinesis offers statistical consultancy services
for sample size calculations and trial design, randomization and
writing or reviewing statistical sections of clinical protocols,
including choosing appropriate hypothesis composition, research
methodologies and suitable endpoint(s).
Common components in
statistical analysis in clinical development are writing of statistical
analysis plans, generation of analysis datasets, data interpretation and
analysis, and production of table, listing and figure displays using
SAS® software.
Other services that Kinesis offers include interim
analysis including statistical evidence for go or non go decisions,
performance of ad hoc exploratory analysis and report this in standalone
statistical reports.
Kinesis’ specialists are familiar with more
advanced statistical methods, including Bayesian evaluation, utilized
for exploratory efficacy, biomarker and safety evaluations. Intelligent
and adaptive trial designs are common practice for Kinesis’ experts.