Archives: Agenda

• Addressing logistical challenges in clinical trials for blood sample processing
• Implementing solutions to stabilise biomarkers at collection and simplify workflows

Running four Phase II oncology studies in parallel exposed a fundamental truth: in clinical-stage biotech, execution failure is not a delivery problem — it is a value problem. This session draws on Ryvu’s experience building an internal clinical execution unit from scratch, covering the strategic decisions behind insourcing key functions, building a CEE-anchored site network, and delivering ASH 2025 data on time. Attendees will leave with a practical framework for thinking about clinical program architecture as a value inflection decision, not an operational one.

• How well‑designed digital measures deliver measurable ROI in clinical trials by reducing missing data, improving statistical power, accelerating timelines, and preventing costly trial rework or failure.
• How an end‑to‑end Wearable Sensor CRO delivery model integrates scientific strategy, operational oversight, and analytics to consistently produce regulatory‑ready datasets.
• Real‑world case examples showing how proactive compliance monitoring and fit‑for‑purpose algorithms dramatically improve data completeness and statistical power.
• The critical role of disease‑specific digital endpoint design versus off‑the‑shelf wearable algorithms in capturing meaningful treatment effects.
• Practical guidance for clinical operations and outsourcing teams on reducing sponsor burden while scaling wearable technologies across global trials.

• Identifying and addressing key barriers that limit timely and representative recruitment.
• Improving collaboration between sites, sponsors and patient advocacy groups to expand referral pathways.
• Enhancing patient trust and understanding through clear, accessible communication strategies.
• Leveraging AI tools to support more accurate pre-screening, eligibility matching and outreach.

• Reimagining responsibilities across clinical trial functions in an AI- and automation-driven environment
• Evolving from task-based roles to strategic, insight-driven contributors across operations and data functions
• Redefining entry-level roles as technology reshapes foundational skills, expectations, and career pathways
• Identifying the new capabilities required to ensure technology enhances, not replaces the expertise of clinical trial professionals

Robust, well supported site infrastructure is the foundation of efficient clinical trial delivery across the UK and Ireland. This session will examine how workforce, facilities, digital systems and governance structures at NHS and HSE sites can be optimised to reduce operational burden and increase throughput of high quality studies. Panellists will share practical strategies for investing in and partnering with sites to strengthen research infrastructure, streamline processes, and enable sustainable growth in commercial and academic trial activity.

• Assessing current site infrastructure: workforce, facilities, governance and digital capabilities in NHS/HSE settings.
• Targeted investments and partnerships that meaningfully strengthen site capacity and trial readiness.
• Aligning sponsor/CRO expectations and processes with real site infrastructure constraints.
• Building scalable, resilient site infrastructure that supports long term growth in UK & Irish clinical research.