Navigating Trial Complexity with RBQM: Practical Strategies for Adopting Risk-Based Approaches
Webinars
Powering an Effective Oversight Strategy with Clinical and Operational Insights
Clinical trial data dragging you down?
Learn how you can leverage your clinical trial data to your advantage for better insights, compliance and outcomes in this fireside chat with life science industry leaders.
Jason Gubb (Global Clinical Operations Consultant), Jason Konn (Product Manager) and Sheila Rocchio (Chief Marketing Officer) will discuss how you can power an effective oversight strategy so clinical trial data is not dragging you down. This interactive fireside chat with live Q&A will outline how to overcome the volume and variety of unique data sources and the velocity of data acquisition in today’s clinical trial landscape.
If you’re among the 75% of clinical teams still spending time in SAS and Excel to integrate data across sources and delivering analysis and insights to downstream teams, this conversation will benefit you. With ICH E6 R2 and impending R3 prescribing a more comprehensive approach to the oversight of clinical trials, risk-based strategies and reliable operational and clinical analytics is critical to trial success.
This fireside chat will share how a single source of truth can power a more comprehensive oversight strategy and include a live demonstration of the elluminate Clinical Data Cloud. Using specific case examples, the speakers will discuss how a single source of truth can power a more comprehensive oversight strategy with faster and more reliable insights to deliver value and improve experiences for cross-functional teams running trials.
At the conclusion of this fireside chat, Jason Konn (Product Manager) will show that by automating data from numerous sources from the start, you can make it available for consumption by clinical teams for better decision-making. Ensuring that your teams collaborate more effectively to make certain of data quality, participant safety and operational excellence.
Key Takeaways
- The role comprehensive analytics plays in establishing an effective oversight to meet referenced regulatory requirements and diversity and inclusion goals, including proposed legislation such as the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act
- How clinical teams will benefit from a centralized clinical data platform that contains both clinical and operational data from numerous sources, including decentralized clinical trial (DCT) systems
- What types of insights are most important for trial oversight
- Case studies illustrating how analytics that power oversight deliver ROI and enhanced collaboration
Who Will Benefit
- Clinical operations professionals
- Clinical trial managers
- Clinical development professionals
- Clinical informatics professionals
Presenters
Clinical Operations Consultant and Co-Founder, ClinOpsClarity
Jason Gubb has more than 25 years of experience in global clinical operations strategy and leadership. He has an applied knowledge of leveraging internal and external data, analytics, digital technology and collaborative partnerships to create actionable insights for study teams. Mr. Gubb works with startups, pharma, vendors and contract research organizations (CROs) to develop innovative approaches to optimize protocol designs, modernize clinical trial conduct and accelerate trial delivery.
Solution Consultant, eClinical Solutions
As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management. Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.
Former Chief Marketing Officer, eClinical Solutions
Sheila has more than 20 years of industry experience including marketing, product management and strategy roles in life sciences technology companies. She spent 15 years at PHT Corporation (now ERT) in a variety of marketing and executive leadership roles helping to drive the company’s growth and the industry adoption of electronic clinical outcome assessments (eCOA). At eClinical Solutions, Sheila managed all aspects of marketing including branding, communications, lead generation and product marketing. She enjoys finding creative ways to tell customer stories, and building products and services that help clinicians, data scientists and technologists do the challenging and important work of bringing life-saving new therapies to market.
