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 (GCP, ICH, US and EU).
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 bioequivalence testing, interim analysis including statistical evidence for go or no-go decisions, performance of ad hoc exploratory analysis and report this in stand-alone 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.
Kinesis has experienced SAS® and R programmers that can assist in database programming activities. Their core expertise is generation of clinical databases, including preparation of NONMEM® databases.