Archives: Agenda

• Identifying community-based organizations that don’t typically participate in clinical trials and helping them to increase their capacity to execute a clinical trial
• Understanding what mitigations and barriers these communities are experiencing
• Exploring tactics and strategies to help these patient populations to overcome obstacles
• Guidance on Diversity Plans to be submitted to FDA

• We will share data collected from partner sites regarding attitudes towards decentralized trials – both positive and negative
• We will discuss different patient perspectives on decentralized trials and how these can differ based on a number of factors
• Finally, we will discuss how we can better operationalize decentralized trials by considering site and patient feedback

• Role of clinical supply chain in within the organization
• Scalability and building an effective internal/external supply chain team
• Strategies for outsourcing supply chain functions
• Developing, maintaining, and implementing consistent and streamlined SOPs, business processes and infrastructure to improve departments effectiveness

Site team responsibilities need to be less time and effort consuming.

PIs need to be more engaged and involved.

The patient’s HCP needs to be integrated.

Site/CRO/Sponsor communication needs to be improved.

“Underrepresented” patients need to be enrolled

• Evolution of clinical trials and need for decentralization
• Regulatory compliance in decentralized clinical trials (DCT)
• Qualification, oversight, and accountability of DCT vendors
• Assurance of quality and consistency of critical study activities performed remotely
• Maintaining control, accountability and subject privacy when delivering IP remotely
• Managing challenges with subject engagement and study compliance
• Ensuring control when things are out of your direct control

• The business case for integrating digital technologies into clinical research
• Elevating the level of patient care and innovative therapies to withstand future threats in the industry
• Managing unprecedented global socio-economic issues and reducing the impact on trials
• Innovative approaches to trial design and execution to reduce vulnerability of clinical trials

Moderator: Robert Loll, SVP of Business Development & Strategic Planning, Praxis

• Exposing the inefficiencies of current vendor qualification practices and challenging the industry to adopt a proven process innovation that will help Sponsors onboard Providers more quickly leading to a real reduction in clinical trial start-up times.
• Learn how embracing innovation, and adopting a risk-based data-driven approach to vendor management can help organizations become inspection ready in a heavily regulated industry.
• Uncover the benefits of a centralized approach to vendor qualification that provides unique benefits to both Sponsors and Providers across the globe.