Indegene helps a leading European medical devices company improve clinical data management and implement relevant EDC platform

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

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