Archives: Agenda

Moderator: Jeff Trickett, Business Advisor, Archetype Therapeutics

• A case study from WinSanTor
• How to best implement innovative e-clinical software systems to ensure they work within the service provider universe
• A harmonious partnership: Balancing innovation and data safety
• When service providers have too much power, how can we ensure innovation isn’t stifled?

• Accomplishing the right vendor selection to ensure better equipped budget and overhead wise for smaller companies
• Optimizing boutique service providers to guarantee the flexibility and attention you need for study start up
• Building the appropriate infrastructure needed to scale up clinical research and knowing when to invest in outsourcing services
• Looking at the latest technologies which are demonstrating that scalability is a solvable problem
• Having a comprehensive understanding of global requirements and timelines

Chair: Robert Loll, SVP, Business Development & Strategic Planning, Praxis

• What are the guidelines suggesting sponsors to do internally, from the perspective of QA, governance and metrics?
• Recommended vendor management reporting: the oversight, the eTMF and data quality/ validation oversight
• How are sponsors going to address these suggested new guidelines from ICH and what are the timelines to react and the most immediate need?
• Understanding updated requirements to document oversight of who is contracted with any sub-contractors
• Focusing on a proportionate risk-based approach to vendor oversight and encompassing a broad range of information
• Addressing the robustness of the Quality Management System or oversight of vendors and highlighting the data types that the ICH suggests
• Processes and practices currently being implemented that are responding well to the ICH guidelines

Moderator: Melody Puckett, Director, GXP Quality, Janux Therapeutics

• Placing data-driven insights at the core: Need for integrating real-world data (RWD) and real-world evidence (RWE) into clinical trial design
• How data-driven insights enhance patient engagement and improve trial outcomes, addressing unmet patient needs?
• Driving patient-centric innovation with AI: Role of AI in personalizing patient selection, optimizing recruitment, and predicting treatment responses
• Bridging silos: medical, commercial, and clinical teams: Impact of collaboration between commercial, medical, and clinical teams to ensure a holistic patient journey
• Harnessing technology for improved trial efficiency: Examples of successful deployments of AI and analytics in clinical trials, showing measurable impacts on trial success rates

• Navigating global data restrictions: Lowering concerns and finding solutions regarding the limitations on research imposed by GDPR in the EU
• Sharing best practice for scaling studies across multiple states and countries despite a lack of consistency with regulations
• Looking at the intersection of data privacy and sample ownership regulations with the business imperative to address new questions that may arise during study analysis
• Addressing concerns at the protocol and ICF development phase