Collaborative sponsor-site partnerships are critical to clinical research success, yet many collaborations remain transactional, study-specific, and difficult to scale. This session features an open discussion between sponsor and Mass General Brigham leaders on practical strategies for building sustainable, enterprise-wide partnerships that improve study design, accelerate startup, and streamline execution. Attendees will learn how integrated workflows, data-driven decision-making, and transparent communication foster more predictable, efficient, and mutually beneficial research collaborations.

Sponsors have consistently collected metrics on site performance for years. However, study performance is only controlled by sites to a certain extent. The actions (or lack thereof) that sponsors take also affect performance. Tufts and AMRC have collaborated on the collection of data from sites which indicates areas that sponsors can improve upon to support site operational efficiency. Specific metrics will be introduced with ratings of performance by sponsors in those areas.

Clinical trial strategy is informed by data, yet patient, site, and study team experiences are not always reflected in operational strategy. This session examines examples of how analytical approaches were integrated with stakeholder experience to shape evidence-based strategies grounded in the patient voice. By aligning data with experience, clinical trial teams can develop smarter strategies, strengthen engagement, and deliver more meaningful impact for patients and research sites.

Novo Nordisk reduced site-facing training burden by over 25% by creating a centralized site learning unit and streamlining processes to deliver optimized learning. By eliminating unnecessary training, accelerating site startup, and strengthening site partnerships, we improved operational efficiency while maintaining ICH GCP E6 R3 compliance. Join us to explore the challenges, solutions, and lessons learned during this transformation.

Patient Negative One challenges an uncomfortable assumption: that reading a protocol prepares a team to execute it. When foreseeable failures can be exposed through simulation, relying on static documents alone becomes ethically indefensible. This industry call to action proposes a digital patient moving through every study system in linked sandboxes, testing workflows, handoffs, and decisions before real patients’ lives depend on them. The first patient should never be the rehearsal.

Clinical research sites devote substantial time to repetitive training that can delay startup and distract staff from study-specific risks—a problem best solved not with less training, but with more targeted training. This session introduces a competency-based, role-based model that helps reduce redundant site training while preserving study-specific instruction, audit readiness, and participant protection. Attendees will see how the Site-Sponsor Consortium’s toolkits can help sponsors and CROs pilot practical improvements to site initiation visit (SIV) and electronic data capture (EDC) training.

Digital protocols have long been explored as a way to streamline clinical trial start-up. Now, TransCelerate and the Association of Multisite Research Corporations (AMRC) have collaborated to evaluate whether this potential can be realized in practice when subjected to site workflows. Through case studies and proof-of-concept implementations, sponsors, sites, and technology providers are evaluating how standards-based digital protocols using the Unified Study Definitions Model (USDM) can streamline clinical trial management systems and eSource setup, reduce administrative burden, and accelerate the path from protocol approval to site activation.This session will explore practical findings, site use cases, and implementation lessons, highlighting how structured protocol data can reduce manual work and rework, improve quality and consistency, and support a more scalable approach for clinical trial start-up.

As clinical trials become increasingly digital and data-rich, principal investigators are often expected to review and attest to growing volumes of information across multiple systems and processes. While signatures and attestations have traditionally served as evidence of oversight, organizations are increasingly looking beyond signatures to identify alternate evidence for demonstrating meaningful oversight of critical trial data and activities. Find out how sponsors, informed by engagement with sites, service providers, and other stakeholders, are reexamining traditional oversight practices through the lens of ICH E6(R3), risk-based quality management, and fit-for-purpose trial execution. Speakers will share practical examples of oversight evidence available today, including metadata, workflow records, and system-generated indicators that may provide a more complete picture of investigator engagement.

Central eSource—a single, protocol-aligned source template built by the sponsor or CRO and deployed across sites—is changing how sponsors capture data at the point of care. This session offers a practical framework for implementing central eSource across a multi-site program, from template design through site onboarding and systems integration, supported by program-level outcomes data on enrollment timelines, remote monitoring shift, and site adoption.

Cutting development timelines in half starts with how data leaves the site. Today sites juggle 20+ sponsor-mandated systems and transcribe source into EDC by hand, while sponsors spend months reconciling the result. Bring Your Own Technology inverts that: sites use their own validated eSource, eConsent, and eRegulatory systems and connect directly to sponsor platforms. This session presents a sponsor-side strategy for a site landscape that ranges from mature EHR/eSource environments to paper, then convenes sponsors and technology providers on validation, governance, and integration—and what changes for site staff who stop being data entry clerks.

The Clinical Research Associate (CRA) role remains highly manual and fragmented, and completion of time-intensive administrative tasks often surpasses the CRAs capacity for high-value activities such as site engagement, relationship-building, patient recruitment and retention support, and inspection readiness. To address this challenge, we are implementing an agentic AI virtual assistant designed to support CRA workflows.

Roughly 37% of clinical trial sites under-enroll study volunteers, and 80% of trials fail to meet enrollment targets on time. Burden falls on both ends of the partnership – sponsors navigating unfamiliar site profiles and sites navigating difficult-to-reach sponsor requirements. This session walks through the site engagement lifecycle phase by phase, spotlighting field-tested toolkits and templates already reducing burden at each step, alongside the tools still missing that sponsors and sites are best positioned to build next.

Emerging sites represent one of the most promising—and most misunderstood—opportunities in clinical research today. They offer access to diverse patient populations, untapped geographic reach, and motivated teams ready to grow. This session equips sponsors and CROs with practical strategies to identify, evaluate, and effectively support emerging sites—transforming hesitation into confident partnership and expanding the research ecosystem in the process.