Archives: Agenda

• How early engagement can improve outcomes
• How do we speak the same language, no one size fits all approach
• Simplifying the complex, in a world of overwhelming outsourcing options and models

• Understand the need for collaborative partnerships with patient advocacy groups
• Discuss valuable insights these groups provide into the patient journey, clinical trial design, and study participation to reduce barriers faced by diverse patient populations
• Share best practices for leveraging advocacy groups to enhance patient recruitment and retention
• Explore how patient advocacy groups help align the objectives of clinical trials with broader diversity and inclusion goals

• Details of my two hybrid clinical trial participations
• What worked well during the trials
• Areas of improvement observed during/after the trials
• Recommendations for ensuring patient-centric trial design

Patient data is the lifeblood of a clinical trial, but the eCOA/ePRO market has yet to live up to the promise of engaging more patients. Sponsors and CROs should expect more. We need an objective look at where the market is lagging, and concrete steps we can take to improve.

• Describe why a legacy eCOA/ePRO system will not deliver the same results as a system developed with modern, digital technology
• Examine how eCOA/ePRO technologies should promote compliance by giving patients apps that are akin to apps they use in daily life, on their own devices
• Discuss how eCOA/ePRO will not become a strategic component of sponsor and CROs technology portfolios unless vendors embrace continuous innovation

• Explore the critical role of equipment in enabling clinical trial success, from ensuring compliance to supporting protocol-specific needs.
• Understand key challenges in the equipment supply chain, including global logistics, maintenance, and vendor management.
• Discover practical solutions, such as centralized planning, global harmonization, and leveraging technology for supply chain optimization.
• Learn from real-world examples illustrating how proactive equipment management saves time, reduces costs, and ensures trial continuity.

• Effectively implementing a risk-based approach to vendor oversight
• How to right-size vendor oversight for our high-risk activities being outsourced
• Why is vendor oversight important and what regulations drive this
• Recognizing the importance of cross-functional collaboration to best manage vendor activity

• Choosing the “right” CRO for your study and ensuring you get the “A” team or the team you were promised: and building a positive relationship with them
• Clearly identifying who is responsible for each action item; especially items that are part of study start up (site ID, feasibility, site qualification) and how to proceed efficiently
• Establishing realistic timelines and practicing constant communication to avoid timelines slipping
• Keeping patients in mind when designing the protocol
• Utilizing updated technology: A look at a recently adopted eISF system and potentially adopting a RBQM system
• Using sites with a diverse population and promising constant communication with them
• Sending an initial budget template early on to help streamline the budget process and identify sites that may not fit within the study budget early on.