The customer sought assistance to create and qualify a custom CPET Analysis Workbook (CPET Workbook). Discrete steps and activities were required to create and collectively demonstrate the CPET Workbook's capability to meet the defined business and regulatory requirements and provide a high degree of confidence in the design and deployment of the CPET Workbook.
- Customer required a validated solution to analyze their cardiopulmonary exercise test (CPET) clinical data.
- Customer’s previous solution required manual manipulations, calculations, and data transcriptions.
- Customer’s QC verification of data often uncovered human error.
- Customer received inconsistently formatted data from investigator sites.
- Customer’s workbook had various anomalies and required modifications to analyze data set types.