Archives: Agenda

This session will offer a deep dive into the practical applications of artificial intelligence (AI) within clinical trials and research settings. Moving beyond theory, we’ll focus on implementing AI solutions, addressing the challenges of navigating the unknown, and defining clear metrics to measure success.

• Identify key AI implementation areas in clinical trials and the tools available and how can the sponsor benefit from such tools
• Understand methods to assess and measure AI-driven initiatives’ success.
• Learn techniques for navigating uncertainties and overcoming implementation challenges.
• Gather and utilize feedback effectively to optimise AI solutions.

This session will delve into innovative approaches to sponsorCRO partnerships, with a focus on building stronger stakeholder relationships, enhancing transparency, and managing teams effectively.

• Identify innovative processes and partnership strategies to elevate sponsor-CRO collaborations.

• Understand the role of transparency and centralised data in fostering trust and alignment.

• Learn how AGILE team management can improve efficiency and responsiveness in clinical trials.

• Gain insights from a case study of a successful sponsor-CRO partnership.

This session will explore the patient experience within clinical trials, and how eClinical solutions can be an essential strategy for easing patient and site burdens.

In this session, we will explore:

• Why do patients participate in clinical trials? The statistics might surprise you.
• The challenges patients experience during their trial journey.
• What the recent updates to the Declaration of Helsinki mean for patient centricity.
• How to make it easier for patients and sites to participate in trials.
• Approaches and technological innovations that improve the trial journey and drive efficiency.

Discover a 5-step framework to define, design, cross-check, measure, and analyze the right technology and operational execution for your clinical trials. This session highlights the eConsent Fit-for-Purpose Study Framework, developed by the non-profit European Forum GCP eConsent initiative in collaboration with over 50 organizations. Additionally, we will explore the importance of harmonized terminologies, study documents requirements, and insights into Ethics Committees’ expectations for eConsent. While focused on eConsent, this approach can be re-used for developing similar frameworks tailored to any technology or Decentralized Clinical Trial Element

ICH E6 (R3) introduces significant updates to Good Clinical Practice guidelines, emphasizing risk-based quality management, patient centricity, and flexibility in trial design and execution. This panel discussion will address the impact of ICH E6 (R3) on clinical trials, comparing it to the previous ICH E6 (R2), discussing approaches to implementation, and considering varied interpretations among stakeholders.

• Understand the key changes in ICH E6 (R3) and their implications for clinical trial conduct.
• Explore different approaches to implementing the new guidelines in diverse trial settings.
• Analyse the challenges, opportunities, and interpretations associated with ICH E6 (R3).
• Highlight meaningful differences between ICH E6 (R2) and ICH E6 (R3) and their practical impacts.

Exploring how new technologies are transforming clinical trial processes, improving efficiency, and addressing challenges. The session will focus on real-world applications, benefits, potential risks, and future implications.

• Why, historically is Pharma so slow to adopt new technologies? Averaging up to 7 years according to a 2022 Tufts Study
• Current Innovations in Clinical Trials; How technologies like General AI and Large Language Models, prognostic and predictive deep learning, and direct data transfer (or EHR to EDC) are enhancing trial efficiency and patient outcomes.
• Overcoming Challenges; Regulatory hurdles: How are agencies responding to new technologies?
• Ethical considerations: Ensuring patient data privacy and compliance.
• Operational barriers: Integration with existing trial frameworks (or do we need to adapt?)
• Future Outlook: What technologies will dominate in the next 5–10 years? (perhaps 7-14 years considering the tech adoption cycle)
• How can stakeholders (pharma, CROs, tech companies, regulators) collaborate effectively??