Archives: Agenda

• How GenAI utilizes existing data and prediction models for clinical trials to reduce the operational burden
• In a conservative and cautious industry, are sponsors truly ready for AI adoption?
• Understanding the risks of diving head-first into a technology many still struggle to conceptualize
• How much risk is too much risk when implementing AI into your trial?
• Why an over-reliance on AI will ultimately fail: The need for human oversight when the tool is deployed and having enough people reviewing the quality of the data that goes into the final dataset
• Examples of successful and unsuccessful AI adoption

Moderator: Amanda Murphy, Senior Director, Data Intelligence & Solutions, GlobalData

• What are KPIs and how are they used to monitor project progress?
• What are best practices for selecting KPIs?
• What are some ways to visually display KPIs for fast understanding and actionable insights?

In this session, we’ll address five of the most common myths surrounding mobile visits, replacing assumptions with real-world data and operational insights:

• Consistent clinician assignments build trust and strengthen patient relationships
• Mobile visits can offer greater privacy and comfort than traditional sites
• Decentralized models can accommodate complex protocols without compromising quality
• Structured planning makes mobile visits logistically viable and scalable
• Bringing research directly into communities expands access and improves retention and inclusivity

• How sponsor and CRO priorities differ, and the importance of clearly defined roles in fostering effective site partnerships
• Key distinctions between site engagement and site management, and how responsibilities should be strategically allocated
• Opportunities for sponsors to strengthen site relationships through proactive engagement and thoughtful collaboration
• Best practices for leveraging CRO networks and KOL partnerships to support site success, particularly in later-phase trials

• Streamlining vendor management to reduce costs and timelines and to improve overall operational efficiency: Clear communication, defined roles and responsibilities and standardized documentation to enhance accessibility and collaboration
• Mitigating risks associated with compliance, quality, and data integrity and reducing the impact of delays in patient recruitment, data collection, and regulatory submissions on trial budgets and timelines
• Setting specific, measurable KPIs to evaluate vendor performance throughout the trial, focusing on metrics such as patient enrollment rates, data accuracy, and timeline adherence
• Leverage technology for real-time monitoring of trial progress and vendor performance, allowing prompt identification of issues
• Comprehensive evaluation of the closing out the trial process: Aligning goals, timelines and encouraging proactive management of timelines to identify potential bottlenecks early and involve vendors in the resolution process

• Voyage of Discovery: Why we crossed the ocean for our FIH Trial
• Speed Dating: Choosing partners for the clinical research dance
• Do You Feel a Draft?: Endless iterations of study-specific documents
• H-Wrecked: navigating unexpected reefs in the journey to study start-up
• Out of Site, Out of Mind

• Acknowledging the value that patients can bring to every stage of the drug development pathway
• Engaging patients and advocacy groups early on in the clinical trial design process
• How minimizing participant burden leads to on-time enrollment and completion
• Combining patient perspectives with those of healthcare professionals to create a holistic trial model
• Highlighting how to compensate patients

Moderator: Amanda Murphy, Senior Director, Data Intelligence & Solutions, GlobalData