Next Generation Data Management Strategies for Clinical Trials

This webinar will highlight how pharmaceutical companies like Karyopharm are employing new methods, business models and technologies for more effective data management outcomes in oncology. The discussion will include perspectives from the sponsor and provider highlighting experience-based best practices from eight trials, including defining a data strategy for improving the end to end clinical data acquisition and cleaning processes and leveraging the benefits of the elluminate® clinical data hub for integrated data analysis and review.

The webinar will cover:

• Karyopharm data management business goals and high level data flows
• Key goals and critical success factors in working with a data services provider and the elluminate® clinical data hub across eight oncology trials
• Lessons learned including successful data management processes, results and metrics tracked and communication and collaboration strategies
• Best practices for effectively using technology for a more agile approach to data management including proactively preparing for amendments to avoid large database changes, structure for handling re-consents and other design recommendations
• Examples of how using a technology platform for integrated clinical data review can facilitate the data review process
• Future plans for further utilizing technology and elluminate® to optimize the data review and management process

Speakers

Lilia Fenelon, Associate Director, Clinical Data Management at Karyopharm Therapeutics Inc.

Lilia Fenelon is currently the Associate Director, Clinical Data Management at Karyopharm Therapeutics where she is responsible for defining data management processes and strategy and overseeing the delivery of key data management deliverables for Karyopharm trials. Lilia has more than 14 years of experience in clinical research with 11 years of experience in clinical data management and project management. Lilia has supported all aspects of trials from startup to submission and has worked with numerous data acquisition and integration technologies used to facilitate the data management process.

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Diane Lacroix, Director, Data Management, eClinical Solutions

Diane Lacroix is a data management professional and leader with 19 plus years in the pharmaceutical/CRO industry. 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 startup through 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 systems and integration and analytics technology platform like elluminate®.

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