09:50

Sponsored by: Digitalizing Protocols: Driving Efficiencies across Clinical Development

Protocol development is central to clinical trial planning, yet today’s workflows remain fragmented and resource-intensive. As trials become increasingly complex, digital protocol solutions can streamline operations and create downstream efficiencies across the study lifecycle. This session explores how protocol digitalization supports structured content capture, automation, and optimization, enabling reuse across key processes. Rather than replacing expert oversight, digital approaches enhance it by accelerating workflows, reducing errors, and improving quality. Attend this session to gain practical insights into how organizations are leveraging protocol digitalization for efficiencies in DDF generation and through Agentic applications such as the EDC Builder, RACT Builder, and Site Selection, while ensuring governance, traceability, and scalability in adoption.

10:40

Sponsored by: AI-Powered Virtual Assistants to Accelerate Clinical Trials: From Protocol to Study Build in Days, Not Months

Clinical trial start-up is often slowed by lengthy builds, complex validation, and resource bottlenecks. Anju will showcase Luminee, a self-serve AI ecosystem of virtual assistants designed to eliminate repetitive tasks, auto-generate study objects, and deliver audit-ready validation. By accelerating database go-live timelines and ensuring data sovereignty, Luminee empowers trial teams to focus on strategic work and bring therapies to patients faster.

15:05

Sponsored by: From Study Design to ICH M11 Protocol: Seamless Digital Transformation through CDISC USDM and Structured Component Authoring Integration

This presentation demonstrates an end-to-end digital workflow integrating Open Study Builder (OSB) with Docuvera to automatically generate ICH M11-compliant protocols from CDISC USDM-structured study designs. Our implementation leverages Digital Data Flow (DDF) principles to establish live links between study design components and protocol authoring systems, enabling real-time synchronization and reusable content management. The integration supports component-based authoring with automated FHIR export capabilities, transforming traditional document-centric processes into data-driven workflows. We demonstrate the complete journey from structured study design creation in OSB through automated protocol generation, review/approval workflows, and regulatory-compliant FHIR output, showcasing how USDM standards enable seamless clinical trial digitization.

15:55

Sponsored by: Next-Gen AI: The Future of Clinical Trial Financial Management

In today’s rapidly evolving clinical research landscape, organisations are under pressure to deliver efficiency, flexibility, and scalability. Sponsors are shifting towards models where intelligent software and AI play a significant role in managing trial finances, driven by the need for streamlined, automated processes. This presentation will review how a powerful combination of advanced technology, specialised services, and deep clinical-trial financial expertise can be used to improve your clinical financial management wherever you are in your development journey.

16:20

Sponsored by: Bringing Research to Every Neighborhood: Expanding Reach to Improve Outcomes

Clinical trials succeed when they reflect the realities of everyday patient experiences. That begins with who participates, where they’re reached, and how they’re supported. This session will explore how expanding access, extending geographic reach, and embedding research in local communities leads to stronger data, lower dropout rates, and more representative outcomes. We’ll unpack how EmVenio’s community-based model improved trial accessibility and dramatically reduced patient dropout in an ongoing Phase 3 influenza study. We’ll also review industry data that challenges traditional assumptions about trial design and site strategy, offering a scalable, inclusive blueprint for future trials.

09:40

Sponsored by: From Sample to Strategy: Holistic Laboratory Partnership to Enable Delivery of Modern Trial Designs

Clinical trial design often overlooks central laboratory insight, risking fragmented workflows and avoidable delays. This presentation advocates for integrating laboratory expertise early in trial design. Case studies will show how proactive collaboration with lab providers enhances efficiency, reduces costly amendments, and optimizes biomarker strategy. We'll demonstrate lab providers as co-authors of research success, offering actionable insights on biomarkers, assays, sample and data flow. We'll also showcase how central lab integration ensures protocols are scientifically robust and operationally feasible.

10:05

Sponsored by: How AI-Powered Protocol Design Influences Outcomes

This session examines practical approaches for optimizing protocol design to improve patient outcomes and trial performance. More specifically: How AI and machine learning analyze protocol choices using WCG’s comprehensive protocol and benchmarking databases. Strategic insights on country and site selection and their influence on recruitment and trial efficiency. Which protocol decisions most significantly affect clinical trial timelines, recruitment, and operational success.

14:05

Sponsored by: The Evolution of Adaptive Protocols: Early Clinical Development

In traditional early phase studies, discrete protocols and studies have been used for healthy volunteer and patient populations. However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drug developers.

Instead of the standard approach where studies are designed to address a primary focus, a parallel study method — a format that incorporates multiple endpoints and objectives, modifications, treatment arms and dose selections into a single protocol — is being rapidly adopted. This results in more complex protocols but provides a flexible, adaptive and proactive approach.