Automation in clinical trials refers to the use of computer programs to automate certain aspects of data collection, cleaning, processing and analysis in clinical trials. Automation has been increasingly implemented in clinical trials with the goal of improving efficiency, accuracy, and speed of the clinical trial process. The use of automation also reduces the chance of human error through its capability to consistently perform repetitive tasks.
MARS can provide expertise and work in collaboration with the sponsor to automate the following:
- Develop standard checks as per Therapeutic Area requirements to automate the process of data validation and cleaning. This can include checks for missing data, out-of-range values, and inconsistencies. By automating this process, data cleaning can be made faster and more efficient, and errors can be minimized.
- Create global standard TFL shells based on Therapeutic area to automate the process of generating TFLs for clinical study reports.
- Develop standard macros to create CDISC compliant standard SDTM/ADAM and TFLs to ensure that the data analysis is accurate and reliable with reduced time and efforts required for development and validation.
