Mitigating Risk, Improving Results: A Better Approach to Protocol Deviations
Webinars
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Transforming and Simplifying Clinical Data Review and Management
The majority of clinical trial data now comes from “external” or non EDC data sources with most trials using at least four data sources and many using six or more. The role of clinical trial data management has changed requiring an increased focus on defining data flows, setting up and managing external data providers and sources along with integrating and reconciling these data and the data review function has become more complex. Providing data access and review capabilities of governed data to key stakeholders including medical monitors, Biostatisticians and clinical CRAs has become critical.
With elluminate® Data Central, data managers and medical reviewers collaborate within the clinical data management software to quickly and effectively manage study data and resolve queries and other data issues. Data Central is a data management workbench that provides a holistic view of all your trial data along with smart listings, flexible workflow and issue management that streamlines your data review process.
What You Will Learn
- What a Clinical Data Workbench is and the value it provides
- How the elluminate Data Central Workbench facilitates comprehensive clinical data review
- Demonstration of elluminate Data Central and key use cases for data reconciliation and review
- Case study of how elluminate Data Central is being utilized by an emerging biotech for
- Cross functional data Review
- Oversight
- Data Visualization
Who Should Attend
- Data Management
- Medical Monitors
- Clinical Scientists
- Chief Medical Officers
- R&D IT Business Partners
Presenters
Director, Data Management, Wave Life Sciences
Jelly Dominic Maratt has been the Director of Data Management at Wave Life Sciences since 2018. Prior to that she has held data management positions at Alexion Pharmaceuticals, Genzyme Corporation/Sanofi, and Genetics Institute/Wyeth. She has over 20 years of experience in Data Management within Clinical Development. She started her data management career at Parexel.
Vice President, Clinical Data Management, eClinical Solutions
Diane Lacroix is a data management professional and leader with over 20 years in the pharmaceutical/CRO industry. As VP, Clinical Data Management at eClinical Solutions, Diane is responsible for leading the data management function including building effective process and implementation strategies to ensure that clients receive maximum value and quality from the elluminate driven data services that Diane’s team delivers. Diane’s career in data management has included numerous leadership roles both at service providers and on the sponsor side. She has worked on all aspects of global trials from study start-up through to database closure and submission leading and managing successful teams and projects to ensure high quality and on-time delivery of clinical data assets. Diane has deep expertise in the oncology and rare disease therapeutic areas and in data management technologies including EDC (Electronic Data Capture) systems and integration and analytics technology platform like elluminate.
