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Clinical Trials Stress Traditional Data Management
Clinical Trials are pushing the capabilities of traditional data management. Clinical trials can generate an unprecedented amount of data. This data, sourced from various systems such as Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), laboratory data, imaging data, electronic health records, and Internet of Things (IoT) devices, is both vast and varied. The effective management of this data is central to the success of the trial.
Organizations often grapple with numerous challenges in managing this data. For instance, ensuring data harmonization and consolidating data from multiple sources and formats are key challenges, cited by 38% and 26% of respondents to a study conducted by IQVIA Technologies and Frost & Sullivan. However, one of the primary challenges is the automation of manual processes related to data for use in oversight.
Despite these challenges, there is growing interest in clinical data analytics and AI/automation platforms. These platforms offer a range of features that can significantly streamline data management in clinical trials. For instance, AI-driven query generation and data discrepancy detection can automate manual processes and improve data quality. Similarly, predictive analytics can provide early signal detection for safety, quality, and risk.
However, it’s important to note that the implementation of these technologies is not without its own set of challenges. Data entry errors, missing data, and inconsistencies may occur during data collection, leading to data quality issues. Therefore, robust data management systems and tools are required to manage and organize this vast amount of data.
The added complexities of data management in clinical trials are significant but not insurmountable. With the right tools and technologies, these challenges can be effectively addressed, paving the way for more efficient and successful clinical trials.