Patient insights are increasingly recognised as essential to clinical protocol development. By engaging patients early, sponsors can identify practical barriers, refine endpoints and procedures, and improve inclusivity. This supports better feasibility, recruitment and retention, and data quality, while aligning studies with real-world needs and reducing avoidable protocol amendments. The presentation will share practical methods, tools, and real examples to integrate the patient voice.

To address scattered insights across the organisation and the business need to integrate patient perspective into decision making, we developed a comprehensive repository that consolidates patient and site insights into a single, accessible platform. Coupled with an AI assistant it enables teams to access relevant insights on demand. This unified approach supports more inclusive, efficient, and patient centered clinical trial designs, ultimately improving trial experience for all involved.

Even in highly outsourced models, sponsors remain accountable for start-up timelines and execution. Protocol quality, and the way it’s pressure-tested before finalization, is one of the strongest levers sponsors still fully control. Sharing some best practices on how to validate that the protocol that we are about to outsource is executable.

This panel brings together members of the Biospecimen Management Consortium (BMC) to share the organization's work toward elevating biospecimen management as a strategic function in clinical research, exploring challenges and solutions associated with standardizing study planning practices across the clinical trial ecosystem. Discussions will encompass cross-document alignment (protocol, biospecimen plan, and lab manual), stakeholder coordination across sponsors, sites, and laboratories, and the development of industry baseline guidelines.

Trials are designed with clinical and exploratory endpoints in mind. To operationalize generation of data to investigate these endpoints, a visit schedule is constructed, and during these visits, participants are asked to give numerous physical samples for lab testing. Currently, ~14 billion lab tests are performed annually.  As the substrate for lab tests, specimens and quality specimen management practices are key to reproducible results, critical for training AI models, and yet, paradoxically, industry-wide best practices for specimen management don't exist. Come hear about our roadmap to build best practice in this new domain, and how these considerations may influence your trial design.

You are part of a global study team, looking for the right country, the right sites, quality, speed— investigator networks can be a valuable partner in navigating a complex and diverse landscape. We are very happy to share our experience in The Netherlands, where sponsors and WCN network successfully collaborate for decades. In a panel discussion we will answer many questions and address different topics on how we can close the gap between design and delivery.

Too often, clinical trial protocols are held together by a patchwork of disconnected platforms and manual workarounds, a system built on repeated data entry, mismatched formats, and limited data consistency. It’s inefficient, error-prone, and a major barrier to accelerating study start-up. This session will explore how biopharmaceutical companies are changing that by digitalizing protocol design and authoring. Using an open-source, vendor-agnostic data model, organizations are automating data flow, improving interoperability across systems, and gaining insight to inform better study design. Join us to see how this approach can unlock new use cases from registry submission to statistical analysis; automate data flow and interoperability between systems; reduce study start-up effort, cycle time, and complexity; improve quality and compliance.​

Pragmatic trials have arguably been characterized more by promise than actual progress. New developments are poised to help shift the balance. The use of pragmatic elements in clinical trials—including broad eligibility criteria, use of electronic health records and patient-reported outcomes—has been a popular topic of conversation, but also a source of great hesitation. While these options create new opportunities for regulatory decision-making, they also present challenges around sponsor oversight and selective safety data reporting.To address these challenges, TransCelerate, in collaboration with FDA’s CDER Center for Clinical Trial Innovation, conducted tabletop exercises to test trial designs under real-world conditions. This session will share key insights and approaches to support more effective design and execution of pragmatic trials. This session will also touch on a new TransCelerate effort to shed light on the use of pragmatic designs to improve safety data collection in connection with ICH E19.

The Sustainable Healthcare Coalition's Clinical Trials Carbon Calculator allows trial designers to predict the climate impact of their clinical trials and evaluate different trial design scenarios. Several major pharmaceutical companies are adopting the tool. We will discuss Johnson & Johnson’s experience integrating the Clinical Trials Carbon Calculator into their own systems, including automation of data entry to reduce user workload and ensure consistent measurement of emissions across their trial portfolio.