Archives: Agenda

• Protocol deviations – missed or swapped samples, mistimed dosing, skipped assessments – quietly compromise trial integrity
• Errors are identified too late with current approaches to clinical trial conduct
• Real-time oversight enables faster, cleaner data through stronger protocol compliance and earlier course correction
• Proactive and risk-based quality management under ICH E6(R3) provides earlier visibility into site execution
• Real-world examples of preventable deviations that delayed trials and jeopardized data

• What is PED and how is it influencing clinical research today
• It all begins with smart science – A strong scientific foundation paves the way for creation of fit for purpose PED strategies.
• Technology is key – Leveraging eCOA and Digital Health Technologies to capture PED
• Data oversight is essential – Using real-time PED monitoring strategies to protect study endpoints
• Keeping it real – We will explore real life examples of how robust PED strategies are used in the context of Obesity & Oncology research

• 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?

• 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

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