Archives: Agenda

• 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

• 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

• 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