11:30 AM

Sponsored by: Building an Agile Outsourcing Operating Model: Yesterday’s Model, Evolved for Tomorrow 

The future of outsourcing lies in flexibility, customization, and true partnership. Jazz Pharmaceuticals and Parexel will share how they’re achieving this, moving beyond a transactional model to build a more strategic, agile operating model. Learn key considerations for creating a collaborative framework tailored to your company’s unique needs, supported by the right expertise and designed to generate both immediate and long-term success.

12:45 PM

Sponsored by: Building an Industry Destination: Strategic Talent Realignment to Optimize Study Management Delivery 

Discover how AbbVie and Syneos Health partnered to transform clinical resourcing through data-driven market analysis and strategic collaboration. This session explores how identifying Specialized Talent Destinations and co-designing scalable transition models can optimize delivery, support workforce globalization, and examine what’s next for flexible delivery models—and how strategic design and partnership can unlock long-term value.

3:55 PM

Sponsored by: The AI Advantage in Clinical Business Operations

AI is transforming clinical trials by automating manual tasks, improving budget accuracy, and accelerating study planning and sourcing. It enhances—not replaces—human expertise. This session explores how AI streamlines clinical operations, strengthens oversight of vendors, timelines, and risks, and delivers practical ways to boost efficiency, cut costs, and enable faster, data-driven trial execution.

4:20 PM

Sponsored by: Reimagining the Resourcing FSP Continuum

Sponsors must have information to make the right resourcing decisions, yet many find themselves stuck between traditional staffing models and evolving delivery needs. This session outlines how a continuum-based diagnostic can help teams assess where they are today, identify internal misalignment, and shift toward modern, scalable workforce strategies that enhance speed, structure, and cross-functional collaboration.

5:10 PM

Sponsored by: Structuring Outsourcing Models for Efficiency, Clarity, and Cost Control

Choosing the right outsourcing model can significantly influence study efficiency, cost control, and the overall sponsor–CRO working dynamic. This session will break down the strengths and limitations of full-service, FSP, and hybrid approaches, highlighting how each model shapes resourcing planning, role clarity, and operational continuity. We will outline how sponsors can determine the most effective mix of insourced and outsourced roles and how pricing structures reflect these choices. The session will also explore how integrated oversight capabilities—such as centralized monitoring—can strengthen quality, risk detection, and visibility across models. Attendees will walk away with practical guidance to select and configure outsourcing approaches that support smoother collaboration and more reliable study delivery.

8:00 AM

BREAFAST PRESENTATION OPTION #1:
Sponsored by: Reaching the Unreachable: Proven Strategies You Can Apply to Engage Underserved Populations in Global Clinical Trials

Underserved populations are often excluded from clinical trials, limiting engagement, scientific validity, and real-world relevance. Traditional strategies often rely on outdated assumptions and overlook patient realities. This session reveals proven, globally scalable strategies to engage these communities through real-world data (RWD), behavioral insights, and human-centered approaches—replacing guesswork with precision to accelerate inclusive trial enrollment and shorten study timelines.

8:00 AM

BREAKFAST PRESENTATION OPTION #2:
Sponsored by: From Elusive to Enrolled: A Case Study in Precision Recruitment 

As the pace of innovation accelerates, scientific breakthroughs bring new hope to patients. Effectively including and supporting underrepresented populations is critical for the success of clinical trials designed to benefit these communities. GCI Health’s experts will share their “secret sauce” for building meaningful engagement with niche communities along with a real-world example of its methodology in action through its work with the University of Florida’s traumatic brain injury trial.

8:35 AM

Sponsored by: Doing the Right Thing: Delivering Individual Data Records to Participants at Scale

Regulatory expectations are evolving and patient engagement continues to be a focal point in clinical trials. Global regulatory bodies, including ICH E6(R3), are stressing the importance of providing patients with access to their clinical trial data. Furthermore, there is increased interest from Patients themselves regarding access to their personalized study results, allowing them to inform their own treatment journeys. Designing a clinical trial that delivers meaningful outputs for patients while remaining focused on engaging sites and reducing their burden is a big challenge. In this session, Teckro and Biogen will explore how scalable technology can support meaningful patient insights alongside site engagement, to run operationally feasible, patient-friendly studies. We’ll share practical tools and approaches for gathering and returning this data, and outline a repeatable process that bridges scientific intent with real-world execution.

9:50 AM

Sponsored by: The Partnership Playbook: Aligning CROs, Imaging, and AI for Smarter Trials

The panel will focus on how imaging CROs, CROs and pharma can strengthen collaboration through effective governance and innovative technology. It will explore practical governance models that balance flexibility and standardization, and highlight how AI and real-time data are transforming operational efficiency and decision-making in outsourced clinical trials. The discussion aims to share lessons learned, best practices, and strategies for aligning partnerships to deliver faster, smarter trials.

11:15 AM

Sponsored by: AI + Humans for Delivery-Ready Clinical and Financial Feasibility

With the vast amounts of data and expertise accumulated in the industry and the power of AI, there’s a potential to eradicate clinical trial delays and change orders. We’ll demonstrate how one platform connects two worlds: financial forecasting and feasibility modeling. The methodology enables accurate feasibility data analysis, data-driven study models with their budgets, and increases the probability of hitting the operational and financial targets.

12:30 PM

Sponsored by: Reclaiming Control: A Modern FSP Outsourcing Model for Emerging Biopharma

Successful biotech trials need speed, capital efficiency, and operational control. Our FSP model, tuned for biotech, delivers transparent governance, disciplined execution, and a clear value proposition for reliable delivery. Our presentation provides the playbook for integrating FSP resources in a way that enables retention of scientific and operational ownership and risk reduction while gaining scalable functional expertise across clinical operations, biometrics, medical writing, and safety.

8:00 AM

BREAKFAST PRESENTATION:
Sponsored by: From Burden to Breakthrough: Innovative Strategies for Site and Patient Support

This presentation explores strategies to strengthen clinical trial site capacity and improve patient engagement. It emphasizes delivering customized solutions through specialized roles that integrate with site teams, flexible resourcing, and operational support across key activities such as prescreening, recruitment, data entry, and remote study visits. Additionally, it highlights the importance of global scalability combined with local expertise, supported by an oversight structure that ensures consistency worldwide. The ultimate goal is to drive measurable improvements in site performance, operational efficiency, patient engagement, and retention, creating a more effective and patient-centric trial experience.