Archives: Agenda

• Exploring the capability of Digital Display Labels (DDLs) and the benefits for Clinical Trial Supplies
• A demonstration of the functionality of DDLs; just in time labelling, lot & expiry update, multiple page count.
• Understanding the operational ability to securely & remotely update content & language.
• Integrating across IMP profiles, vials, bottles, blisters.

• 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.