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Indegene helps a leading US-based pediatric medical institution achieve 40% reduction in study closeout time to improve data management for Oncology studies
The Customer
A leading US-based pediatric medical institution that focuses primarily on testing next-generation cell and gene therapies for pediatric diseases.
Challenges
Lack of an end-to-end clinical data management solution resulting in data management complexities
Implementation of a suitable Electronic Data Capture (EDC) platform
Indegene Solution
The US pediatric medical center deals with high volume of complex data from Oncology clinical studies, which involve multiple patient cohorts, and multi arms multi stage (MAMS) trials. They sought to implement a robust Electronic Data Capture (EDC) system and streamline data management to efficiently manage this data. Indegene's clinical research and statistics SMEs built a solution to improve data management and statistical analysis. As part of the solution, we:
Deployed a regulatory-compliant EDC platform which the institution could use to get suitable insights from various clinical trials, for their specific study needs
Implemented global libraries, standardized data capture forms, and verification checks within the centralized data management framework, which increased the reusability of key study components
Delivered well-structured study builds that could meet the unique requirements of Oncology trials, accommodating multiple visits, cohorts, and arms characterized by their complexity
Outcomes
In today’s rapidly evolving life sciences industry, efficient clinical data management is crucial for the success of clinical trials. The remarkable outcomes: 100% accuracy in error detection and a 40% reduction in study close-out time, achieved by the customer demonstrate the transformative potential of innovative solutions and technologies in clinical operations function.
40%
reduction in
study setup time
100%
accuracy in error
detection
