Navigating Trial Complexity with RBQM: Practical Strategies for Adopting Risk-Based Approaches
Webinars
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The growing complexity and influx of data sources in oncology trials present challenges for medical data reviewers when monitoring adverse events and patient safety and determining drug efficacy. Many of the top global life science companies turn to the elluminate® clinical data cloud as the digital foundation of their Oncology trials to provide real-time insights into patient disease response rates, safety signals, trends and more to help with these challenges.
In this new Academy Webinar, two eClinical Solutions senior medical data reviewers with in-depth oncology experience will demonstrate five unique use cases from over 50+ standard oncology visualizations in elluminate to spot safety signals and measure efficacy from real-time data analytics. They will share how the ability to raise issues within elluminate for the distribution of safety signals and risk helps facilitate team discussions to address patient safety more effectively.
What You Will Learn
- Five elluminate oncology medical review use cases for safety signal detection across your various domains including labs, prohibited meds against inclusion/exclusion criteria, etc.
- Review of tumor distribution, response assessments, waterfall plots, and overall survival visualizations as safety and efficacy measures in elluminate.
- How data comparisons with Investigator assessment can drive effective conversations between investigators and medical monitors.
Who Should Attend?
- Medical Data Reviewers
- Data Management
- Clinical Operations
- Data Sciences
- Oncology R&D Stakeholders
Presenters
Senior Clinical Data Reviewer, eClinical Solutions
Donna Lacroix is a Senior Clinical Data Reviewer with eClinical Solutions. She works with a team of Clinical Data Reviewers, who are responsible for performing scientific data review of subject level patient data via data visualizations, and other reporting tools to ensure medical plausibility, adherence to protocol and to ensure overall data quality and safety. She is an Oncology Certified Nurse, (OCNZ©) with > 35 years of clinical experience at UMass Memorial Medical Center, and most recently Dana Farber Cancer Institute in Boston. She has clinical expertise in the fields of pediatric and adult oncology, hematology/oncology, bone marrow transplant and clinical trials.
Principal Data Reviewer, eClinical Solutions
Mohan Pulluru is a Principal Clinical Data Reviewer with eClinical Solutions. He works on the Clinical Medical Review team that are responsible for Clinical study review and subject level patient data via data visualizations, data listing and reporting tools to ensure medical plausibility, adherence to protocol and to ensure overall data quality. Mohan has a MBBS and a Masters in Diabetology with 17 years of Medical experience as a Physician and 10 years focused on Medical Data Review.
