Navigating Trial Complexity with RBQM: Practical Strategies for Adopting Risk-Based Approaches
Webinars
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Self-Service Access To All Clinical Data for Faster and Easier Medical Review
Medical review of clinical trial data is a critical component of the clinical development process. The process of medical monitoring requires access and analysis of all clinical data sources in order to understand the holistic patient experience along with data trending and exploration capabilities. In many clinical development organizations currently, medical review is conducted on data sets that have been cleaned and are provided to the medical team in a visualization tool or via programmed SAS listings. The Medical Monitors review this data, ask questions or request clarifications which are in turn sent back to data management, clinical operations, medical coding and biostatistics teams and the process begins again.
The use of technology to facilitate data review has not dramatically improved this process as it still resembles an assembly line approach versus an agile or iterative one that allows all parties to access the same data sources and act upon it in real time for continuous oversight and ever improving quality along with a richer clinical understanding of the patient experience.
The elluminate® platform is intended to solve this problem by providing one, centralized source of truth that data managers and medical monitors can work from collaboratively. This webinar describes how the elluminate platform supports and improves the medical monitoring process by providing self-service access to all clinical data with role based workflow and data lineage resulting in faster and easier medical review. The webinar will include the following examples that demonstrate how the elluminate platform makes the medical monitoring process easier and less time consuming. Key topics and use cases covered in this webinar include:
- Reviewing patient safety data trends and analyses for safety oversight
- Exploring data from patient and sites that show outlying or unexpected data values and identifying issues for follow-up
- Comprehensive data across systems and sources by patient through interactive patient profiles
- Collaborating with data management and clinical operations to resolve queries and quality issues
We will also discuss the benefits of the elluminate clinical data platform including automation, data standardization and governance, data storage and provisioning for all roles involved in the clinical development process.
The webinar is intended for:
- Chief Medical Officers
- Medical Directors
- Clinical scientists
- Data Managers
- Clinical Operations
- R&D IT Business Partners
Presenter
Senior Manager, Solution Consulting, eClinical Solutions
Achilleas has 12+ years of experience in software industry involving software demonstrations, managing a team of 15+ developers, hands-on coding in Microsoft .Net platform and Business Intelligence Suites like QlikSense. He has enjoyed a progressive career in diverse roles including responsibilities of a Sales Engineer, Team Manager, Software Engineer and Business Intelligence Analyst in various industries like Banking, Retail and now the Pharmaceutical industry with eClinical Solutions.
