Archives: Agenda

• The Vaccine Innovation Pathway: delivering results and shaping the future
• Real-world innovations in site-level delivery
• Reimagining clinical research delivery: innovative models and collaborative approaches
• Expanding primary care horizons: commercial trials in the community
• Driving innovation from industry: lessons learned and future directions

MODERATOR:

Moderator to be confirmed

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

Suzanne McNally, Executive Director in Portfolio Management, Parexel

• An overview of the MHRA’s primary care research database, Clinical Practice Research Datalink
• Using electronic healthcare research data (EHR) to find, recruit and follow-up patients for clinical trials
• Considerations when using EHR data for finding and recruiting patients – advantages and limitations
• Case studies on EHR enabled clinical trial patient recruitment and lessons learned