Archives: Agenda

• How to build a strong CRO onboarding plan that sets your study up for success
• Making your kickoff meeting count: aligning teams, timelines, and expectations
• Fast-tracking your study start-up — from project plan to site activation
• Anticipating and mitigating early risks to protect your study timelines

• Ensuring data accuracy: utilize eCOA to capture patient-reported outcomes in real-time, reducing errors and enhancing data reliability
• Streamlining patient enrollment: implement IRT to manage patient randomization and drug supply logistics, ensuring compliance and minimizing risks of bias
• Enhancing patient compliance: leverage eConsent to provide clear, accessible information to participants, ensuring informed consent and improving retention
• Strengthening data security: integrate robust encryption and authentication measures across eCOA, IRT, and eConsent platforms to protect sensitive data and maintain trial integrity
• Facilitating regulatory compliance: ensure all digital tools comply with regulatory standards (eg FDA, EMA) to streamline approval processes and enhance trial credibility

• Streamlining feasibility, site selection and qualification processes to minimize delays
• Leveraging technology to manage documents, workflows and communication
• Identifying common bottlenecks and strategies to overcome them proactively
• Aligning sponsor, CRO and site teams to ensure clarity from day one

Explore how artificial intelligence is revolutionizing the speed, quality, and consistency within clinical trials through innovative technologies and real-world applications. This presentation explores:

• Preparing your organization
• How to identify AI opportunities and associated value
• Real life examples of using AI to accelerate clinical trials

• DEI in rare diseases: how to ensure your trial participants represent the overall population in trials with limited patient numbers
• Navigating FDA regulations and devising a strategy for diversity and inclusion
• Building trust and relationships with communities who may not traditionally participate in clinical trials
• Working with advocacy groups to increase trial diversity and patient numbers

MODERATOR:

Robert Loll, Senior Vice President, Business Development and Strategic Planning, Praxis

• Review the results of a public and patient survey on the use of AI to develop clinical trial documents
• Assess patient level of trust in and comfort with the use of AI to generate patient-facing clinical trial documents
• Discuss the patient’s views on the importance of human review of AI-generated content and implications for the future

During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations. Roundtables will take place in the Stream A conference room.

ROUNDTABLE 1: Navigating biological material regulations

Sean D. Smith, Biological Threat Exclusion Coordinator (BTEC), US Customs and Border Protection

ROUNDTABLE 2: Keeping patients at the heart of your clinical trial

Behtash Bahador, Senior Director, Community Engagement & Partnerships, CISCRP

ROUNDTABLE 3: Fostering a positive relationship with your CRO and vendor partners

Liza Micioni, Director, Clinical Operations, Tris Pharma

ROUNDTABLE 4: Negotiation tips for emerging startups

• Discover how to achieve unparalleled accuracy and patient compliance through cutting-edge, low-touch technology
• Dive into the transformative power of AI and explore real-world applications reshaping cardiac care
• Understand how continuous monitoring ensures precise data collection and enhances patient adherence and safety
• Uncover the revolutionary role of AI in interpreting cardiac data
• Review practical examples and case studies demonstrating effectiveness of continuous cardiac monitoring in clinical settings