Archives: Agenda

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