Archives: Agenda

• 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

• 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