Archives: Agenda

Jehan Poco, Associate Director, BDM Planning and Functional Excellence, Biostatistics and Data Management, Daiichi Sankyo, Inc
Kevin Douglass, Associate Director, RBQM Center of Excellence, Biostatistics and Data Management, Daiichi Sankyo, Inc

• Incorporating innovative products and tools into your clinical trial for remote data capture
• FDA regulatory guidance around data acquisition and collecting data in remote settings
• Easing burden on patients through remote data collection: how to utilize these tools effectively
• How new tools such as eCOA solve patient issues

MODERATOR: Terry Katz, Senior Director, Biostatistics and Data Management Planning and Functional Excellence, Daiichi Sankyo, Inc

• Understand how the increasing complexity of clinical trials, higher competition, and site staff turnover are driving the need for more engaged site support
• Learn how (CROs) provide crucial support through improved communication and tailored site resources
• Explore how sponsors can enhance site performance through clear expectations and data-driven collaboration
• Discover strategies for streamlining processes and improving site engagement to drive trial success

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss 0ut!

• Explore the critical role of equipment in enabling clinical trial success, from ensuring compliance to supporting protocol-specific needs
• Understand key challenges in the equipment supply chain, including global logistics, maintenance, and vendor management
• Discover practical solutions such as centralized planning, global harmonization, and the use of technology to optimize supply chain performance
• Learn from real-world examples that illustrate how proactive equipment management can save time, reduce costs, and ensure continuity across trials

• Reviewing last year’s FDA feedback on audits: what were the main reasons for failure?
• Tips and tricks to ensure you are ready for inspection
• Simplifying processes in order to prepare for an FDA inspection

MODERATOR: Judyth Zahora, Senior Director, Clinical QA and Process Improvement, Zentalis Pharmaceuticals

• How vital is knowledge of therapeutic area in CRO selection?
• As a small biotech, is it beneficial to work with a smaller CRO or a large global CRO?
• Ensuring your CRO and vendor partners prioritize your study

• An overview of emerging therapy areas including women’s health, cell and gene therapy and rare diseases
• Designing a successful patient recruitment strategy: common challenges and how to overcome these
• Vendor sourcing: key considerations in vendor selection
• How important is therapeutic area knowledge when choosing CROs and partners?