Archives: Agenda

• Everything starts with strategic site selection and feasibility
• Understand the value of patient engagement and measuring its impact on the trial successful completion
• Know your sites, know their needs, customize your support
• Innovative patient centric approach: defining a set of strategies designed to place the needs, preferences, and experiences of patients at the

• Overview of the value proposition and expected financial return of patient engagement practices
• Review of current adoption levels of patient engagement practices
• Assessment of the impact of patient engagement practices on performance and quality
• Discussion of opportunities to optimize patient engagement and its impact

• Priorities and strategies for small biotech in partnering with CROs and vendors
• Breaking down the myths
• Identifying the right partners
• Cultivating collaborative relationships
• Managing the partnership

• High-level study metrics and plan
• Discover data outliers with intuitive dashboards
• Deep dive into the data with the Data Browser
• Standard Reports, including Key Risk Indicator to track site trends
• Create unlimited custom, user generated reports

• Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
• Staff turnover and layoffs: handling changes in the industry in order to ensure success
• New regulations and guidance around clinical trials in the US: how will this impact you?
• An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

• 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

• 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