How to Get Better Clinical Data, Faster
Rethink your approach to data management
Traditional EDC systems impose challenges when it comes to delivering clinical trials. Firstly, the design and build of clinical trials is slow and inflexible and has not significantly changed in over 15 years. The design process does not consider the value and criticality of data being collected and all data is considered equal whether primary end-point or non-core. Cycle times still take weeks for review and approval.
Second, there are inefficiencies in data collection and review. 70% of study data bypasses EDC systems completely, requiring study teams to research in other locations to find the information needed to make decisions in a trial. Sites today still rely heavily on paper and site coordinators spend a large portion of their time on transcription. Despite risk based monitoring entering mainstream, source data verification still plays a major role in clinical trials. Query volumes are tens of thousands in phase 3 trials, and takes weeks or months to resolve. EDC systems today do not bring immediate actionable insights to study teams.
Lastly, the cost of administration in clinical trials is a huge overhead. Complex study designs are not fully supported. And design amendments require system downtime. Most EDC systems today were authored in the 1990’s and have complex data models with a lot of data duplication and no straightforward non-eCRF data integration strategy.
Modern EDC enables faster study build, easier data collection, and lowers the cost of clinical trial administration. It is easy to integrate modern EDC systems across various sources and get actionable insights from complete and concurrent data. The future of clinical trials is to be built and executed on a single platform where content and data are seamlessly integrated and that includes EDC, eSource, CTMS, eTMF, and more, all on the same platform as a true cloud solution.
Modern Data Management
To understand what a modern EDC system should look like and how this alters clinical trials, watch this webinar to learn how to make clinical data management the foundation for improved clinical trials. Tony Tsai, Product Manager of Vault EDC will join us in this webinar to give a hands-on demo of a modern EDC system. We will explore what modern clinical data management comprises of and how EDC can be transformed to be a centralized asset in clinical trials that reduces time to market of drugs.