KAI has an in-house full service statistics group with experience in designing and writing protocols and statistical analysis plans (SAP); designing and implementing sampling statistics and randomization procedures; carrying out interim and final analysis of the data. They contribute to the writing of clinical study reports and provide results for submission to the FDA. KAI's staff comprising this group have PhDs and MS degrees in statistics, epidemiology and information management and have worked in the pharmaceutical industry, NIH, FDA and academia.
KAI has been a leader in implementing both adaptive design and randomization. We are constantly researching new study designs that can increase the study efficiency while preserving the integrity of the analysis. Additionally, we make use of business intelligence software which allows project managers and sponsors to analyze the data without having to rely on access to a programmer.
In regards to submissions to regulatory agencies KAI has developed a battery of validated SAS programs and macros that can be used to produce statistical reports, listings and tabulations that are customarily included in IND, NDA and BLA submissions to the FDA, and in support of DSMB meetings. These SAS programs can be quickly implemented to keep programming development time down and get submission ready output to the client. KAI has carried out statistical analysis on data from a variety of EDC and medical monitoring systems.
KAI statistical team can be used on a consulting basis to write or review protocols or SAPS, provide independent review of previous statistical analysis, carry out interim analysis or present statistical evidence before regulatory agencies. Randomization systems using the Web or interactive voice recognition software can also be implemented for clients.
Statistical Analysis & SAS Programming