Archives: Agenda

The Future of RBQM for Early Phase Studies Starts Here

RBQM is essential for protecting patient safety and driving quality by design principles across all phases of clinical research and is arguably more important in early phase studies than any other. Yet in practice, the application of RBQM to early phase is highly inconsistent, often relying on manual processes and individual judgement instead of structured processes, supported by compliant technology.

In this session we’ll share where the gaps are in RBQM adoption and implementation, what’s at stake when sponsors get this wrong, as well as how to move forward to implement a rigorous RBQM strategy for your trials. Attendees will leave with actionable insights on how flexible, structured monitoring can:

  • Improve visibility into what’s been reviewed, by whom and why
  • Drive efficiency and consistency without rigidity
  • Enable better decision-making and prioritization across diverse study designs.

 

This session will provide you with a roadmap to bringing early phase studies into the RBQM fold.

TRI TRIALS

Powering Pragmatic Decentralised Trials with Real-World, Real-Time Data

  • Discover how routinely collected healthcare data can power the next generation of pragmatic and decentralised clinical trials.
  • Learn how integrating real-time electronic health record (EHR) data into trial workflows can accelerate recruitment and reduce burden on sites and patients.
  • Explore practical approaches for generating high-quality real-world evidence alongside traditional interventional study data.
  • Gain insight into the technology, governance, and operational partnerships required to deliver scalable, patient-centric research models in practice.

Unlocking UK trials through primary care: predictable, accurate and fast recruitment

UK clinical research faces a persistent challenge in translating study design into timely, predictable recruitment at scale. Ongoing variability in feasibility, slow start‑up and fragmented patient identification continue to affect delivery, site workload and participant experience.

In this presentation, Solutions Specialist Isabel Hunt will demonstrate how closer collaboration with primary care, underpinned by comprehensive, coded general practice data, can address these challenges end to end. Using the Recruit solution, embedded within the UK’s leading GP clinical systems, sponsors and CROs can enable predictable, accurate and fast recruitment through improved feasibility, faster identification of eligible patients and trusted GP‑led engagement at scale.

Attendees will learn how Recruit reduces time to first patient in, lowers screen failures, minimises site burden and supports more reliable trial delivery. The session will also explore how secure, consent driven primary care data supports ongoing study delivery and real‑world evidence generation across the UK.

Europe at a Crossroads: Modern Clinical Trials, Market Pressures, and the UK’s approach in the global competitive environment

  • The traditional CRO model is no longer fit for purpose
    Transactional, vendor-based approaches create duplication, misalignment, and inefficiency, slowing trials precisely when regulatory systems are designed to move faster.
  • Integrated partnerships are the new execution engine for clinical trials
    Success in Europe now depends on deeply integrated CRO-biotech models with shared accountability, centralized oversight, and proactive regulatory strategy built in from the start.
  • Winning in 2026 requires a global, lifecycle-driven strategy
    Biotechs can combine different global solutions for early phase acceleration.

INSPIRATIONAL KEYNOTE Clinical Operational Excellence: Delivery like an Elite Athlete

  • What is the Athlete Mindset?
  • Parallels between elite sport and clinical trial delivery
  • Applying the athlete-style discipline, goal-setting, ‘pivot quickly’ mindset and performance tracking in delivering complex oncology trials
  • Translating setbacks into learnings and future strengths- The drive for continuous improvement-The perfect race!
  • Sustaining performance and energy across multi-year clinical trials- The Long-Distance Athlete

KEYNOTE: A New Chapter for UK Clinical Trials: Regulation Reform and the Rise of AI

  • The impact of the new UK clinical trial regulations coming into force in April 2026 and what they mean for sponsors, investigators, and trial delivery
  • Government priorities and progress across the UK clinical research ecosystem two years on
  • How artificial intelligence is transforming clinical trial design, feasibility, patient identification, and operational efficiency
  • Cross-sector collaboration between regulators, industry, and the NHS to strengthen the UK’s position as a leading destination for clinical research
  • Looking ahead: building a more agile, technology-enabled clinical trials environment in the UK

PANEL DISCUSSION Harnessing Real-World Data and Registries in Clinical Trials: UK & Ireland Perspectives

  • Overview of available RWD sources and disease registries across the UK and Ireland, and how they can support trial design.
  • Leveraging RWD to inform patient eligibility, site selection, and endpoint development.
  • Practical considerations for integrating registry data with trial datasets while ensuring data quality and regulatory compliance.
  • Case studies demonstrating how RWD and registries have accelerated clinical trial insights and improved patient outcomes.