REVOLUTIONIZING CLINICAL TRIALS

09:00 Emerging Trends and Technologies Transforming the Future of Trial Design and Execution

The landscape of clinical trials is undergoing a radical transformation, driven by cutting-edge technologies and innovative methodologies. This session will explore the latest advancements reshaping trial design, patient recruitment, data collection, and regulatory compliance. From AI-driven analytics and decentralized trial models to real-world evidence and digital biomarkers, we will discuss how these emerging trends enhance efficiency, reduce costs, and improve patient outcomes. Attendees will gain valuable insights into the future of clinical research and the strategies needed to navigate this evolving ecosystem.

09:25 Questions & Discussion

09:30 MAXIMIZING EFFICIENCY IN CLINICAL TRIALS

How Adaptive Trial Designs Are Transforming Drug Development, Reducing Timelines, and Enhancing Statistical Power

In an era where speed and precision are critical in drug development, adaptive trial designs are revolutionizing clinical research. This session will delve into how innovative methodologies—such as seamless phase transitions, response-adaptive randomization, and platform trials—are optimizing resource allocation, accelerating timelines, and improving decision-making. Attendees will gain insights into real-world applications, regulatory considerations, and the statistical advantages that make adaptive trials a game-changer in modern clinical development. Whether you're a researcher, regulator, or industry professional, this talk will provide practical strategies for leveraging adaptive designs to enhance trial efficiency and success rates.

09:55 Questions & Discussion

FROM DATA TO DISCOVERY

10:00 Enhancing Drug Development Using AI and Machine Learning to Streamline Clinical Trial Processes and Decisions

The integration of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing drug development by optimizing clinical trial processes and improving decision-making. This talk will explore how AI-driven predictive analytics, automation, and real-time data insights are accelerating patient recruitment, enhancing trial efficiency, and reducing costs. We will discuss real-world applications of AI in protocol design, risk assessment, and adaptive trial strategies, highlighting case studies that demonstrate tangible benefits. Attendees will gain insights into the latest advancements in AI-driven clinical research and how these innovations are shaping the future of drug development.

10:25 Questions & Discussion

REAL-WORLD EVIDENCE IN TRIAL DESIGN

10:30 Enhancing Trial Design with Real-World Evidence to Bridge the Gap Between Research and Clinical Practice

In the evolving landscape of clinical research, real-world evidence (RWE) is playing a crucial role in complementing traditional randomized controlled trials (RCTs). This talk explores how integrating RWE into trial design can improve study efficiency, enhance patient diversity, and generate findings that are more applicable to real-world clinical settings. Key topics include methodologies for leveraging RWE, regulatory perspectives, and case studies demonstrating its impact. By bridging the gap between research and practice, this approach helps accelerate the development of treatments that are both scientifically rigorous and practically relevant for patients.

10:55 Questions & Discussion

11:00 Morning Refreshment Break

MASTER PROTOCOLS

11:30 Optimizing Clinical Trials with Master Protocols Accelerating drug development through adaptive and efficient study designs.

In an era of rapid medical advancements, traditional clinical trial designs often struggle to keep pace with evolving scientific discoveries. Master protocols—umbrella, basket, and platform trials—offer a transformative approach by enabling the simultaneous evaluation of multiple therapies, indications, or patient subgroups within a single framework. This session provides an in-depth look at how adaptive and efficient study designs streamline drug development, reduce costs, and accelerate the path to regulatory approval. Attendees will gain insights into the latest innovations, regulatory considerations, and real-world applications of master protocols in clinical research.

11:55 Questions & Discussion

Digital Evolution

12:00 Advancing Digital Biomarkers in Next-Gen Clinical Trials Unlocking Real-Time Patient Insights for Precision Medicine

The integration of digital biomarkers into next-generation clinical trials is revolutionizing drug development and patient care. This session offers insights into how real-time data collection through wearables, sensors, and AI-driven analytics is enhancing patient monitoring, improving trial efficiency, and enabling precision medicine. We will discuss key advancements, challenges, and regulatory considerations in leveraging digital biomarkers to accelerate innovation and personalize treatment strategies. Attendees will gain insights into how these cutting-edge technologies are shaping the future of clinical research and transforming healthcare.

12:25 Questions & Discussion

COMPLIANCE TRUST CHALLENGES INNOVATION

12:30 Regulatory and Ethical Challenges Ensuring Compliance and Trust in Digital Biomarkers for Clinical Innovation

This talk will explore key regulatory frameworks governing digital biomarkers, including FDA, EMA, and GDPR compliance requirements. It will also address ethical considerations such as informed consent, data transparency, and algorithmic fairness. By examining real-world case studies, we will discuss strategies to navigate these challenges, foster trust among stakeholders, and ensure that digital biomarkers serve as reliable and ethical tools for clinical innovation.

12:55 Questions & Discussion

13:00 Lunch Break

ENHANCED OVERSIGHT

14:00 Optimizing Risk Based Monitoring Approaches to Enhance Data Quality Site Performance and Trial Efficiency Globally

In today’s evolving clinical research landscape, risk-based monitoring (RBM) has become a critical strategy for ensuring high-quality data while optimizing site performance and trial efficiency. This session will explore innovative RBM methodologies that leverage advanced analytics, centralized monitoring, and adaptive risk assessments to enhance oversight across global clinical trials.

Key discussion points include:

• Enhancing Data Quality: Leveraging RBM to identify and mitigate risks proactively, ensuring data integrity and compliance.
• Improving Site Performance: Utilizing targeted monitoring approaches to support sites efficiently, reducing burden while maintaining regulatory adherence.
• Boosting Trial Efficiency: Streamlining operations and resource allocation through risk-based strategies to accelerate trial timelines and outcomes.

Attendees will gain insights into best practices and real-world case studies demonstrating how RBM can drive more efficient, high-quality, and globally scalable clinical trials.

14:25 Questions & Discussion