Company insight
Next generation clinical data management
Genius DAMA (Next Generation Data Management and Analytics) by Exom Group introduces a new data-centric approach to data management through automated, real-time and continuous running of quality checks, queries and identification of wrong and missing data and data reconciliation across eCRF forms.
D
espite improvements and enhancements in data management technologies supporting clinical trials during the past decade, data management cycle times paradoxically have gotten longer. The Tufts CSDD Impact Report 2019 showed that the time from the last patient visit to database lock, for example, increased from an average of 33.4 days in 2007 to 36.1 days in 2017. This situation has not changed significantly over the past five years. There are some significant challenges clinical teams are facing when it comes to the study finalisation. Firstly, they are spending valuable time cleaning data rather than analysing it. Secondly, the time wasted reconciling clinical trial data issues is detrimental and costly and can result in anything from slight delays to the complete failure of study results. These challenges will only become more difficult to navigate as the volume and variety of data and data sources continue to increase. A survey among clinical research professionals involved in clinical data management worldwide, performed by Pharma Intelligence and Oracle Health Sciences confirmed that data managers struggle with processes and environments that fail to deliver the desired data governance and quality. Many clinical research professionals are concerned about their data's quality, consistency, and traceability. The impact of these findings is that most professionals lack confidence in the quality and completeness of their clinical trial data from an audit and compliance perspective. But in today’s technology-driven world, an efficient solution to address this challenge is a fully integrated clinical trial digital ecosystem, which provides unified data for continuous, automated, and real-
Clinical Trials Insight /
www.worldpharmaceuticals.net
Genius DaMA allows for enhanced patient safety and higher quality data collection.
time advanced data management. Rather than trying to compare data across multiple platforms, study and data managers who use these holistic tools can view standardised data that leads to actionable insights in one place.
Genius focus
Genius DAMA (Next Generation Data Management and Analytics) by Exom Group introduces a new data-centric approach that, through an automated, real-time and continuous running of quality checks, queries, identification of wrong and missing data and data reconciliation across eCRF forms, improves quality and accuracy of data entered by investigators from first patient- in to last patient-out. It also reduces the human labour-intensive activity and data batch approach in programming and cleaning. Furthermore, it provides a complete picture of trial data, taken from the various data sources in real-time to get visibility into the trial and make better decisions more effectively, and efficiently.
An end-to-end clinical analytics framework, like Exom Group’s ‘Genius WIZARD’, ensures there is a more efficient and comprehensive management of clinical trial and safety data from the source generation at sites to the final database lock. The seamless integration within the same ‘Clinical Trial Data Science’ working group of clinical site monitors, data mangers and safety officers applying ‘Genius DaMA’ framework, speeds up the collection, cleaning and risk detection and assessment, for a more accurate and higher quality data, enhanced patient safety and new level of monitoring efficiency. In summary, ‘Genius DaMA’ accelerates data cleaning, increases regulatory quality, reduces costs, and significantly reduces time from LPO to database lock. It transforms data cleaning into real-time actionable insights. Finally, it can increase subject safety by providing a historical warehouse, enabling the execution of cross-trial safety queries. ●
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