The Customer
A leading European Medical Devices company wanted to improve their clinical data management to improve the study startup time and reduce error rate in study report to ensure accurate analysis of the trials data
Challenges
European based medical devices company faced:
Significant data management complexities and lack of expertise to identify and implement the right Electronic Data Capture (EDC) platform
High error rate in study reports due to inefficient manual data analysis
Indegene Solution
Indegene’s SMEs from clinical research and statistics built a solution to streamline data management and improve statistical analysis. As part of the solution, we:
Developed a detailed data management plan outlining standardized data collection procedures and formats for all study sites
Trained site coordinators on data entry protocols and standards that improved the accuracy, reliability, and integrity of the data collected
Created a centralized data repository to collect, store, and integrate data from all sites seamlessly and prevent duplicate data flows
Conducted statistical analysis of the data for site-specific variability by including site-specific characteristics and covariates
Deployed a regulatory-compliant EDC platform that is suitable for the organization’s specific study needs
Outcomes
40%
reduction in study setup time
100%
accuracy in error detection
50%
reduction in cost