Navigating Trial Complexity with RBQM: Practical Strategies for Adopting Risk-Based Approaches
Webinars
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The need for more efficient, patient-centric approaches in drug development is ushering in a new era of innovative clinical trials such as master protocols and adaptive designs that enhance flexibility and accelerate the identification of effective treatments. While these novel approaches are vital tools for improving patient outcomes, especially within oncology and rare diseases, they significantly increase the complexity of data handling, from collection to analysis. This complexity mirrors a wider shift in clinical research towards a more data-rich environment drawing on a wider variety of emerging data sources.
In this context, a well-defined data strategy that ensures the efficient collection, integration, management and analysis of the diverse data generated in complex trials is critical. Close alignment across clinical data functions provides a robust foundation that enhances adaptive capabilities, reduces data bottlenecks and inefficiencies and supports more informed, timely decision-making.
This webinar brings together clinical data experts from clinical data acquisition, data management and statistical analysis disciplines for an interactive conversation exploring the vital roles of technology, collaboration and flexibility in navigating the complexities of this new type of clinical trials.
Webinar attendees will benefit from insights into designing flexible, future-proofed electronic data capture systems; proactive data management strategies that deliver real-time insights and seamlessly handle external data including biomarker and patient-reported outcomes and the importance of incorporating statistical input across the data lifecycle. The role of advanced technologies including clinical data platforms that integrate diverse data types from various sources, as well as the application of artificial intelligence and machine learning approaches to manage the increased volume, variety and velocity of data in innovative clinical trials will also be discussed.
Through discussion and practical examples, the speakers will highlight the positive impact of cross-functional collaboration and integrated data strategies in complex clinical research, helping to reduce cycle times and pave the way for new breakthroughs.
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Presenters
Chief Delivery Officer, Biometrics Services, eClinical Solutions
Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 25 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much at home scaling operations as she is in developing strategies that drive revenue growth. At eClinical Solutions, Katrina was recently promoted from Executive Vice President of Professional Services to Chief Delivery Officer. She has previously held various technical roles at Lockheed Martin Energy Group and Bayer. Katrina holds a Bachelor of Science degree in Computer Science from Alabama Agricultural and Mechanical University and a Master of Science degree in Computer Science with Advanced Applications from the University of New Haven. In her free time, Katrina is an active participant of Chief, a private network for women in senior leadership roles, Treasurer in her church where she oversees all financial aspects and a Member of the Delta Sigma Theta Sorority Incorporated, a not-for-profit organization dedicated to public service with an emphasis on programs that assist the African American community.
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.
Vice President, Biostatistics and Statistical Programming, eClinical Solutions
Demi Niforos is VP, Biostatistics and Statistical Programming for eClinical Solutions and has more than 20 years of drug development experience in both the CRO and Pharmaceutical/Biotech environments. Prior to joining eClinical Solutions she held leadership roles in biostatistics and data management across multiple companies including YM Biosciences, Viventia Biotech and AAIPharma. She has extensive expertise in the clinical development process from study planning to agency submission. Prior to joining eClinical Solutions, Demi led Biostatistics and Data Management for Arbutus BioPharma. Demi holds an M.S. in Applied Statistics from Worcester Polytechnic Institute and a B.S. in Mathematics and Science from Worcester State College.
Sr. Director, Clinical Programming, eClinical Solutions
Grant Williamson has 15 years of experience in clinical programming and data management. As the Sr. Director, Clinical Programming at eClinical Solutions, he drives the combination of technology and clinical development expertise to guide life science companies through the optimal design, implementation, and use of all their data capture systems.
