People come in all shapes and sizes. But in addition, kidney function, body mass index, liver function and many other physiological factors can influence how long drugs persist in our bodies.
When monitoring a clinical trial, it is essential that medics know how much of a dose of a new therapy is left in the blood. By examining how the concentration of drug changes with time, statistics can be calculated that help medics decide whether the dose is too high (toxic) or too low (ineffective).
These statistics, derived by Non-Compartmental Analysis (NCA) of the concentration profiles are regularly performed as standard during clinical trials. However, this analysis can be time consuming to perform. In addition, extra time needs to be spent creating clear reports for communication with team members. The trial team are interested in understanding the statistics by subject (are individuals being exposed to the treatment at the right level) and by group (are different formulations behaving in the same way). These documents are also needed for reporting the trial, and recording why decisions were made.
RapidNCA is an application for the quick performance of non-compartmental analysis via a streamlined and controlled workflow process. The application streamlines routine work, accelerating and automating report production.
- Intuitive, visual interface which prompts and supports users through each stage of the process
- Interactive graphics
- Ability to read CSV, Excel (XLS, XLSX) and SAS transport (XPT) files
- Data checking on import
- Validation of entry fields to ensure existing projects are not overwritten
- Database lock to ensure the data source cannot be modified during data import
- Recording of access and changes to data
- A selection of audited, reproducible analyses
- Output of statistics tables
- Summary or detailed report generation – in both PDF and spread sheet form
High quality reports are generated in 3 easy steps:
- Import and map the data
- Review the data and confirm reporting hierarchy
- Create Reports
Mango Solutions are pleased to offer web demonstrations of RapidNCA upon request.