Archives: Agenda

What is Patient Experience Data (PED)?

With a focus on clinical trials, and a data management perspective, Ane will cover study design considerations, patient burden, missing data and other challenges

In the complex world of clinical research, even meticulously planned trials can face unexpected hurdles that threaten to derail progress and encounter obstacles beyond the capabilities of a small-scale Clinical Research Organization (CRO). When studies falter, a well-executed rescue strategy with an experienced global CRO becomes crucial. Drawing from Parexel’s extensive rescue-trial experience, this presentation unveils the blueprint for successful clinical trial transitions, focusing on four key phases:

• Strategic Initiation & Planning – establishing a robust framework and standardized processes
• Comprehensive Preparation & Due Diligence – ensuring stakeholder alignment on transition plans and timelines – Conducting thorough documentation review and gap analysis
• Adaptive Execution & Transfer – How to operationalize a study transfer – Anticipating challenges and employing agile governance for real-time course corrections
• Effective Closure & Delivery – defining clear transition thresholds and success metrics  – Ensuring continuity and maintaining data integrity throughout the process

• Examples from integrating DHTs, such as wearable devices, into clinical trials
• Device burden and patient-related factors
• Challenges faced by sites during DHT implementation

• Incorporating digitalization and new technologies into your clinical trials
• AI & collaborative platforms: improving communication and efficiency among stakeholders
• Success stories, transformative case studies and key takeaways

Discussing the status quo of clinical trials in Denmark and beyond including factors influencing country selection

• Considering barriers of success for site-set up and patient recruitment/screening
• Considering types of data that can be utilized to assist with patient recruitment challenges
• Incorporating data findings into development of eligibility criteria
• Using secondary health data to identify sites and patient cohorts

• Building an organization with capabilities to reach an NDA-approval
• Transitioning from development to registration phase – what does it take?
• The importance of vendor governance and collaboration
• Preparing for next steps
• Key challenges and mitigations

• Selecting a CRO in Japan
• Discussing PMDA negotiations, regulatory landscape and inspection readiness
• Sharing challenges and benefits of conducting trials in Japan
• Overcoming initial doubts and providing lessons learned from partnerships between sponsor and CRO in Japan