Advancing Trial Delivery

2026 ARCHIVES

Enhancing Point-of-Care Research: Solutions & Partnerships

SCOPE’s 15th Annual Advancing Trial Delivery stream showcases innovative models and strategies for improving the accessibility, efficiency, speed, and quality of clinical trials. This year’s program highlights several key drivers of change: expanding research into everyday healthcare settings through point-of-care solutions and partnerships, integrating flexible decentralized approaches and technologies into mainstream operations, scaling innovation strategies, and advancing eClinical capabilities to modernize operations. Case studies and discussions will address operational considerations, partnering strategies, and evidence-based approaches for improving participant experience while shortening trial timelines.

Part 1: Enhancing Point-of-Care Research: Solutions & Partnerships

Part 2: eClinical Evolution

Monday, February 2

7:00 amGolf Check-In & Breakfast Buffet*

8:00 am– 3:30 pm MaxisAI: INSPIRE Agentic AI Summit

12:00 pm– 4:00 pm IQVIA Technologies Innovation Day

1:00 pm– 3:30 pm Using Data and AI to Accelerate Trials: WCG User Group and Product Roadmap Discussion

1:00 pm– 3:30 pm Enhancing the Efficiency of Pipeline Delivery: Disruptive Scenarios and Strategic Responses

2:00 pm– 3:30 pm OPEN WORKSHOP: Modernizing Informed Consent: AI, Automation, and Ethics in Global Clinical Trials

For more details on Pre-Conference Events, please visit: Workshops/User Groups

9:00 amRegistration Open

9:00 amSCOPE's 5th Annual Masters of Clinical Research Golf Tournament* SOLD OUT (Sponsorship Opportunities Still Available)

Network on the greens at SCOPE's 5th Annual Golf Tournament! Visit the SCOPE Summit website for player and sponsorship opportunities.

1:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)*

1:00 pm– 3:45 pm SCOPE'S Pickleball Networking Session: Paddles & Partnerships

Kick off the SCOPE 2026 conference with food, fun, and pickleball! Whether you're a pickleball pro or have never picked up a paddle, this event is perfect for everyone. Limited spots available. Register Here

2:00 pmClose of the Masters of Clinical Research Golf Tournament

*Limited spots available. Separate registration and fee apply.

3:45 pmGrab Your Seat: Early-Bird Seat Golden Ticket Raffle & Prize Giveaway! *

*Must be present to win.

3:50 pm

Organizer's Welcome Remarks & 5th Annual Masters of Clinical Research Golf Tournament Awards and Jacket Signing

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

3:58 pm Chairperson's Introduction

Rob Goodwin, COO, Parexel

4:00 pm FIRESIDE CHAT:

Hope: The Double-Edged Sword of Patient Experience

Lindsay Guentzel, Multimedia Journalist & Patient Advocate

Jane Myles, Vice President, Programs and Initiatives, Decentralized Trials & Research Alliance (DTRA); Vice Chair, The Myositis Association (TMA) Board of Directors

Brad Watts, CAR T Recipient and Patient Advocate, Emily Whitehead Foundation

In this fireside chat, two CAR T trial participants and a patient advocate/clinical research professional unpack the journey: find the trial, fight the insurer, cross state lines, then live the trial reality, along with your family. Careful research, long consent forms, and great care teams can still miss key things that matter. For clinical researchers, we share a clear look at what we ask—and what patients still can’t see.

4:25 pm

Tips for Getting the Most out of SCOPE

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

Visit our FAQ page! We hope this page answers some of your questions related to SCOPE. It consolidates a lot of info for speakers, attendees, and vendors into one page. We look forward to seeing you at SCOPE on February 2-5, 2026, at the Rosen Shingle Creek in Orlando, Florida! https://www.scopesummit.com/faq-how-to-succeed-at-scope

4:33 pm Chairperson’s Introduction: Developing Site Relationships beyond Study-Level Engagement

Elisa Cascade, Chief Growth Officer, Head of Americas, TrialScreen

4:35 pm

SCOPE's 3rd Annual Site Innovation Awards

Wouter Daniels, Clinical Trial Patient & Site Engagement Lead, Boehringer Ingelheim Pharma GmbH & Co KG

Angela DeLuca, Associate Vice President, Global Study Operations, Amgen

Irfan Khan, CEO, Circuit Clinical

Mara Kramer, Feasibility Transversal Projects Lead, Global Clinical Early Operational Strategy, Sanofi

Sean Soth, Senior Vice President, Strategy and Global Business Partnerships, SCRS

Amanda Wright, Co-Founder & Senior Vice President, Healthcare Alliance, Javara

We are excited to announce our 3rd Annual Site Innovation Award, recognizing sites and partnerships pioneering new approaches to improve clinical trials. This is an opportunity to highlight your successes and be recognized by your peers for your dedication to advance clinical research. By sharing your actionable solutions, you will inform the broader Clinical Operations Community at SCOPE. Our definition of innovation is inclusive of low-tech or high-tech solutions, or any site operations-related process improvements that effectively reduce site burden and improve a site’s ability to advance clinical research while providing patient-centered care. The Site Innovation Awards program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/site-innovation-award

5:05 pm SCOPE's 10th Annual Participant Engagement Awards Introduction: Industry Mandate and Collaboration for Expanding Access to Clinical Trials

Mike Martin, Drug Development Practice Area Lead, R&D Consulting, ZS Associates

5:10 pm KEYNOTE INTERACTIVE PANEL:

SCOPE's 10th Annual Participant Engagement Awards

PANEL MODERATORS:

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

Kelly McKee, Vice President, Strategy & Transformation, Science 37; Co-Creator of the SCOPE Participant Engagement Award

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC; Co-Creator of the SCOPE Participant Engagement Award

Now in its 10th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2026 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/participant-engagement-award

PANELISTS:

Beth Brooks, Head of Patient Insights & Behavioral Sciences, Patient Informed Development & Health Value Translation, Sanofi

Mark Evans, Managing Director, Patient Recruitment Expert

Jameka Hill, Senior Director, Clinical Trial Health Equity, Moderna, Inc.

Neha Shah Londono, Director, Clinical Trial Diversity and Community Engagement Lead, Pfizer Inc.

Samantha Rogers, Director, Patient Engagement & Patient-Centered Innovation, Raven (RA Ventures)

Brad Watts, CAR T Recipient and Patient Advocate, Emily Whitehead Foundation

5:40 pmSCOPE's Winter Games Opening Reception (Sponsorship Opportunities Available)

Break out your coolest Winter Games—inspired look—no snow required! Think country flag t-shirts, Olympic colors, or your favorite team gear. While we may be in sunny Florida, let’s ignite the spirit of unity, energy, and excitement—as we toast to teamwork and triumph!

7:00 pmClose of Day

Tuesday, February 3

6:00 amSunrise Yoga: In Gratitude for Clinical Research Participants

Join us at sunrise for a restorative yoga session celebrating the invaluable contributions of clinical research participants. Led by a trained instructor, this all-levels practice will focus on mindful movement, breath, and grounding—no experience necessary. Yoga mats and towels will be provided by the hotel; just wear comfortable clothing. During this yoga session, CISCRP asks participants to join us in showing gratitude for the individuals who have participated in clinical research. Each ticket includes a complimentary breakfast and a branded CISCRP yoga towel. Proceeds from this event help support CISCRP's mission. Yoga begins at 6:30 am.

Registration Link: https://www.ciscrp.org/sunrise-yoga

6:30 amSCOPE's 5K Rise and Shine Fun Run! (Sponsorship Opportunities Available)

Lace up and join SCOPE’s Coordinators for the Fun Run on Tuesday, February 3! Sprint, jog, walk, or talk-your-way-through—ALL abilities are welcome. This informal event is all about getting moving together. New meet-up location for 2026! Meet outside at the back of the Gatlin Terrace by the paved path. We will do three loops around the property, do as few or as many as you have time for, but we will start promptly at 6:30 am! Meet us in the Rosen Hotel’s Gatlin Terrace at 6:30 am sharp!

7:30 amRegistration Open

7:30 amMorning Coffee (Sponsorship Opportunities Available)

Fuel your morning with made-to-order coffee and sweet bites, courtesy of our sponsors.

8:25 amGrab Your Seat—Early Bird Seat Raffle & Prize Giveaway!* (Sponsorship Opportunity Available)

Don’t miss your chance to win! Arrive early, grab your seat, and take part in SCOPE’s Early Bird Seat Raffle & Prize Giveaway. Exciting prizes are up for grabs—must be present to win!

8:30 am

Welcome to SCOPE 2026—Welcome to the Clinical Trials Factory

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

8:38 am Chairperson's Plenary Keynote Introduction: Patient Engagement as a Guiding Principle in Research

Lisa Moneymaker, Chief Strategy Officer, Medidata

8:40 am

KEYNOTE FIRESIDE CHAT: Aligning Purpose, Innovation, and Operational Excellence in Clinical Development

Eliav Barr, Head, Global Clinical Development and CMO, Global Clinical Development, Merck & Co.

Pharma’s mission to deliver life-changing therapies depends on its ability to innovate while staying grounded in execution. This keynote will highlight how companies are aligning purpose with investment in new clinical models and technologies. The conversation will focus on where big pharma is directing innovation strategy—and how operational alignment ensures impact for patients and the healthcare system.

Interviewed By:

Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

9:05 am

SCOPE’s Stretch Break & Annual T-Shirt Toss

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

Take a quick pause to stretch, recharge, and enjoy a little SCOPE tradition—our Annual T-Shirt Toss! Watch for the t-shirt slingshot sending giveaways into the audience as we add some fun to your day.

9:15 am KEYNOTE PANEL DISCUSSION:

From Years to Months: Is Radical Acceleration in Clinical Research Possible?

PANEL MODERATOR:

Jeremy Goldberg, Operating Partner, Healthcare, Arsenal Capital Partners

Clinical development timelines remain one of the biggest barriers between breakthrough innovation and patients in need. Incremental process tweaks won’t cut it—what’s required is a step-change in how trials are designed, executed, and financed. This keynote will push beyond theory into bold, actionable strategies for compressing timelines, rethinking operational models, and deploying capital where it can have the greatest impact. Leaders will examine how smarter investment, data integration, and operational transformation can turn years into months—and what will truly move the needle for the future of clinical research.

PANELISTS:

Sandeep Burugupalli, Head, Data Science & Biopharmaceuticals R&D, AstraZeneca

Shawne Moran, Head, In-Country Study Operations-Americas, EMD Serono/Merck KGaA Darmstadt, Germany

Jared Saul, MD, CMO, Commercial Healthcare and Life Sciences, Amazon Web Services

9:45 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall —Best of Show Voting Opens

Step into SCOPE’s one-of-a-kind exhibit hall! With 300+ leading clinical trial technology and service companies, it’s the place to discover new partners and reconnect with familiar ones. Cast your vote for SCOPE’s Best of Show, recharge with coffee, snap a photo, and don’t forget your comfy shoes—you’ll have miles to explore!

Part 1: Enhancing Point-of-Care Research: Solutions & Partnerships

11:00 am Chairperson's Remarks

Jeff Huntsman, Chief Commercial Officer, EmVenio

11:05 am

Enabling Research at the Point-of-Care: What Will It Take to Get Patients, Providers, Regulators, and Life Science Companies to Collaborate?

Kevin Bugin, PhD, Head, Regulatory Policy and Intelligence, Amgen

Robert DiCicco, Vice President, Portfolio Management, TransCelerate BioPharma, Inc.

If we’re going to improve patient health outcomes, then we must collaborate quite differently than most of us are used to. The groundwork is being laid: Individual organizations, consortia, and government agencies are all intent on making research at the point of care an everyday reality by generating high-quality data that supports regulatory decision-making, informs practice guidelines, and improves outcomes. This session will review efforts to date and explain why the time is now—right now—to collaborate in this space.

11:20 am

Beyond Dispensing Medications: How Retail Pharmacy Is Improving Access to Clinical Trials

John Campbell, Head of Decentralized Trials, Walgreens Co.

Bringing clinical research into nontraditional sites like community pharmacies has improved, among many other things, clinical trial conduct through expanded collaboration with trusted care partners like pharmacists. As the pharmacy profession continues to evolve, hear from a Walgreens pharmacist supporting clinical research and a site manager on their experience bringing this novel approach to clinical trials to community pharmacies.

11:35 am

Rethinking Pharma Research in a Changing Landscape: How DCT and Hybrid Models + Dynamic Blended Data Can Reduce Cost and Improve Access

Adam Mariano, President and General Manager, LexisNexis Risk Solutions

Damion Nero, PhD, Global Head of Statistics for HEOR/HTA, Daiichi Sankyo, Inc.

Today’s complex web of intermediaries can inflate drug costs, while unrepresentative patient datasets continue to exclude diverse populations from clinical trials. These challenges make traditional models unsustainable. This session explores how direct-to-consumer and hybrid strategies—powered by community partnerships and real-world data that reflects all populations and accounts for social drivers of health—can help reduce costs, accelerate research, and expand equitable access to therapies in an evolving policy landscape.

11:55 am

Site and Patient Realities: New Data and What It Means for Technology’s Role

Dave Hine, Associate Vice President, Financial Services, Suvoda LLC

Andres Escallon, Vice President, eCOA Solutions Strategy, Suvoda LLC

With the increasing complexity of clinical trials, we are seeing a heightened responsibility and burden placed on both patients and sites. In this session, we will share insights from the industry’s most critical stakeholders—patients and clinical sites—shared in the 2025 CISCRP Perceptions & Insights Study and captured from Suvoda’s Site Advisory Board. The consensus? There is a growing need for streamlining and flexibility. In an industry where technology can be overwhelming, we will discuss how unified solutions can bring patients and sites together—reducing workload, enabling greater visibility, and ultimately delivering a smoother clinical trial journey.

12:20 pm PANEL DISCUSSION:

From Access to Outcomes: Insights on Decentralized Trials and DTP Shipments

PANEL MODERATOR:

Joan Chambers, Senior Consultant, Tufts Center for the Study of Drug Development

Decentralized clinical trial (DCT) solutions, including remote and virtual approaches, have been available for more than 15 years, with adoption peaking during COVID-19. In this presentation, empirical insights and data will be shared showing that patients and sites are highly receptive to direct-to-patient shipment of investigational treatments. The session will also highlight how the flexibility, access, and convenience of DCT solutions can improve patient recruitment, retention, and overall clinical trial performance.

PANELISTS:

Jimmy Bechtel, Chief Site Success Officer, Society for Clinical Research Sites (SCRS)

Shelly Barnes, Global Clinical Innovations and Digital Lead, UCB

Sandeep Bhat, MSE, Principal, Visualized Ventures, LLC

Maria P Ladd, Co-Founder, Clinical Research Site Collective

12:45 pm

Unlocking Outcomes: Innovative Central Lab EDC Driving Site-to-Lab Digitalization, Engagement, and Data Integrity

Kelli Aufderheide, Director Decentralized Trial Solutions, Decentralized Trial Solutions, IQVIA

Clinical trials are going digital—but site-to-lab workflows have lagged behind, creating delays, inefficiencies, and added burden. This session reveals how real-time electronic data capture (RT EDC) and e-Requisition are closing that gap and transforming trial delivery. Discover how leading organizations are achieving dramatic results: query rates cut from 20–25% to as low as 1%, resolution times reduced from a week to under two days, and thousands of visits processed seamlessly across global sites. Learn how these efficiencies accelerate timelines for sponsors, reduce administrative load for sites, improve patient care, and support sustainability goals.

1:10 pmSponsored Networking Luncheon

Recharge, refuel, and connect over lunch—compliments of SCOPE sponsors! Enjoy a well-deserved break.

2:10 pmNetworking Coffee & Dessert Break in the Exhibit Hall

Keep the conversations going in the Exhibit Hall with coffee and dessert, courtesy of SCOPE sponsors. Network with colleagues, explore new products and services, and don’t forget—Best of Show Award voting is still open, so be sure to cast your vote!

2:15 pmSpecial Book Launch & Signing

Barnett's Good Clinical Practice: A Question & Answer Guide 2026/2027
Editor-In-Chief: Donna Dorozinsky, RN, MSN, CCRC
Location: Booth #129 (Free copies for the first 30 visitors!)

3:00 pm

Chairperson's Remarks

Laurie Berry, PhD, Director, Strategic Solutions, Pfizer Inc.

3:05 pm

Evolving Clinical Trial Teams for High Performance with a Center of Excellence

Melissa Taranto, Director, Clinical Trial Team Center of Excellence Lead, Novartis

Clinical Trial Teams (CTTs) drive fast, high-quality, patient-centric research. A CTT Center of Excellence (CoE) empowers global teams through innovation, operational excellence, and AI-driven solutions. This scalable, cross-functional model enhances collaboration, ensures consistency, and elevates compliance and outcomes across programs—transforming clinical delivery through science and synergy.

3:25 pm

Precision Operational Excellence by Trial Type: Elevating Clinical Execution

Melody Aldred, PhD, Study Director, Community Lead, SSO GCO Development, Novartis

Operational Excellence empowers clinical teams to upgrade, innovate, and streamline trial execution. Each trial type—Phase 3 registration, rare disease, pediatric—operates within a unique ecosystem. A precision operational model aligns strategy with execution, enhancing efficiency and data quality. This tailored approach enables scalable excellence, ensuring every trial benefits from optimized operations and accelerated outcomes.

3:40 pm

Scaling Patient- and Site-Centered Operational Innovations: The Novartis Operating Model for Sustainable Success

Sean Lynch, Clinical Innovation Head, Innovative Trial Operations, Novartis Pharmaceuticals

Heidi Pereira, Vendor Program Strategy Director, Novartis

How does a novel operational innovation become a model application? This session explores how Novartis’s Clinical Operations Innovation and Vendor Partnership teams drive scalable innovation in clinical trials. Hear how a structured operating model and cross-functional collaboration align innovations with business needs and transition pilots into routine practice. We’ll also share how we assess the innovation landscape, identify opportunities, and ensure sustainable value through effective vendor engagement and governance.

3:55 pm

The Scientific Risks of Commoditizing eCOA

Melissa Mooney, Director, Patient Solutions Engineering, Solution Engineering, IQVIA

Lindsay Hughes, Principal, Patient Centered Solutions, IQVIA

As eCOA adoption grows, scalable off-the-shelf solutions risk eroding scientific rigor. In this presentation, IQVIA experts Lindsay Hughes and Melissa Mooney will explore how commoditization threatens eCOA’s foundational principles and how to preserve integrity. Topics explored include: The behavioral science roots of eCOA, the impact of rapid tech growth, risks of misaligned implementations, and strategies to bridge science and technology.

4:20 pm

ET at Home: Light Years from the Clinic—Designing Decentralized Trials That Meet Patients Where They Are

Jeff Huntsman, Chief Commercial Officer, EmVenio

Megan Sniecinski, Chief Business Officer, Praxis Precision Medicines

Join us for a deep dive into the design and execution of a fully decentralized Phase 3 trial for Ulixacaltamide, an investigational therapy for essential tremor. This session will explore how Praxis Precision Medicines leveraged patient-centric solutions to support trial participation entirely from home. This case study illustrates how decentralized trial models can drive both operational efficiency and meaningful patient impact. The discussion will highlight trial-design considerations, engagement strategies, and operational learnings, with broader relevance for community-based approaches in neurology research.

4:45 pm

Investing in Patients: The Impact on Trial Delivery and Outcomes

Miriam Dervan, CEO, MDGroup

Scott Dixon, Chief Commercial Officer, Commercial, MDGroup

Erin Finnegan, Director, R&D Outsourcing Finance, PTC Therapeutics, Inc.

As clinical trials grow more complex, patient experience is increasingly recognized as a critical driver of success — but still often treated as optional rather than essential. In this breakout session, mdgroup and PTC Therapeutics explore what changes when patient experience is approached as a deliberate strategic investment.

Drawing on real-world insights from a complex Huntington’s disease study, PTC leaders will share why they chose to prioritize patient support, how that decision influenced trial delivery, and the tangible impact on recruitment, retention, operational confidence, and outcomes. The discussion will also examine how patient-centricity is evolving across the industry, what separates intent from execution, and what “best-in-class” patient experience will look like in the next generation of clinical research.

5:10 pm PANEL DISCUSSION:

Transforming Protocol Digitalization to Streamline Clinical Trials

PANEL MODERATOR:

Viral Vyas, Director, IT, Global Clinical Development, Bristol Myers Squibb

Industry alignment is fundamental to innovation and change. Regeneron, BMS, IQVIA and Nurocor have come together to demonstrate how we can do more together for utilizing protocol and SOE digitization to dramatically streamline clinical trial setup process and increase quality. Together, we are transforming protocol digitization creating a centralized source of truth for the sample journey that eliminates manual data-entry, automates lab setup and reduces sample reconciliation for clinical trials.

PANELISTS:

Jolene Hill, Vice President, Solutions Consulting, Nurocor, Inc.

Michel Tarabocchia, Director, Precision Medicine Operations, Translational Medicine, Regeneron Pharmaceuticals, Inc.

Alexander Watt, Vice President & Head of Global Partnerships, IQVIA

5:35 pmWelcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)

Wrap up the day with colleagues, friends old and new at SCOPE’s Welcome Reception in the Exhibit Hall. Enjoy drinks, network with exhibitors, and enter to win fabulous raffle prizes (must be present to win). Keep the evening going with dinner at Rosen Shingle Creek’s restaurants—no Orlando traffic required!

7:00 pmClose of Day

7:00 pmSCOPE Out the Restaurants and Shops at Pointe Orlando, via Our Courtesy Shuttle* (Sponsorship Opportunities Available)

Enjoy an evening exploring the restaurants and shops at Pointe Orlando with transportation provided by our courtesy shuttle. Shuttles will run until 11:00 pm, with the last pick-up at 10:30 pm.

*Times subject to change. More details closer to the event.

Wednesday, February 4

6:00 amSunrise Yoga: In Gratitude for Clinical Research Participants

Registration Link: https://www.ciscrp.org/sunrise-yoga

7:30 amRegistration Open

8:00 am

BREAFAST PRESENTATION OPTION #1:

Reaching the Unreachable: Proven Strategies You Can Apply to Engage Underserved Populations in Global Clinical Trials

Tobias Kruse, PhD, Managing Director, Europe, SubjectWell

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:

From Elusive to Enrolled: A Case Study in Precision Recruitment

Matthew Graffeo, Managing Director, Healthcare & Digital, GCI Health

Nikki Buchmayer, Senior Vice President, Digital, Clinical Trial Recruitment, GCI Health

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.

8:00 amSponsored Breakfast Presentation (Opportunity Available)

8:00 am– 9:00 am WORKING GROUP BREAKFAST: Pharma Leadership Forum: Overcoming Geopolitical Challenges in Clinical Development (Invite Only)

MODERATOR:
Demetris Zambas, Vice President & Global Head, Clinical Data Sciences, Pfizer Inc.

Global clinical development is increasingly vulnerable to geopolitical forces. Sponsors face rising risks in running global trials, requiring proactive and diversified strategies to maintain momentum and safeguard patients. A group of top clinical research leaders from biopharma companies will get together at SCOPE to exchange ideas and case studies and to explore opportunities for sponsor companies to unify their efforts. Some of the challenges to be discussed include regulatory divergence, supply chain disruptions, patients recruitment in global trials, data security & sovereignty, IP protection, and cyber threats.

8:25 amTransition to Sessions

8:30 am

Chairperson's Remarks

Jeff Kozloff, CEO, RealTime eClinical; Chairman, ProofPilot

8:35 am

Imaging without Friction: The Missing Link in Faster, More Accurate Trial Delivery

Patrick McNamara, Chief Commercial Officer, Yunu, Inc.

Clinical trial imaging is a main source of operational frustration - creating delays, deviations, and rework. Drawing on real-world data, this session examines key failure points in trial imaging and their measurable impact on trial outcomes. Patrick McNamara, COO of Yunu, discusses how standardization, real-time oversight, and earlier quality intervention have reduced repeat imaging, shortened cycle times, improved data accuracy, and accelerated trial delivery while reducing operational burden.

8:48 am

Local Roots, Global Reach: Redefining Decentralized Clinical Research in APAC through the Local Care Model

Rachel Soon, Director, Janssen Clinical Innovation

DCT has largely been shaped by Western healthcare systems—but what does decentralization look like in a region as diverse and infrastructure-variable as Asia-Pacific? In Malaysia, we piloted a novel LCM that redefines DCT by exploring the healthcare ecosystem surrounding a patient to identify local polyclinics where trial assessments can be conducted with minimal burden. In strategic partnership with Clinical Research Malaysia (CRM), and with strong support from key opinion leaders and principal investigators, we co-developed a framework that integrates local clinics, labs, and community providers into the research pathway. This model holds promise for transforming access to research in emerging markets and advancing global health equity.

9:10 am PANEL DISCUSSION:

Oncology Trials in the Community: The Rise of a Decentralized Ecosystem

PANEL MODERATOR:

Dawn Sauro, President, DS Clinical Consulting

The future of oncology research is being reshaped from the ground up. Once centered in academic medical centers, oncology clinical trials are increasingly moving into community settings — driven by the need for broader access, greater diversity, and more patient-centric care. Innovative players are standing up trial-ready sites in partnership with community oncologists, large oncology practice management groups are providing research infrastructure to support research within their practices and others are partnering with established research networks. In parallel, technology solutions leverage data, natural language processing and artificial intelligence to help patients find and enroll in trials closer to home and sponsors /CROS to identify niches of patients in their respective disease focus. As these decentralized models gain momentum, a critical question arises: how can we ensure that community-based trials remain aligned with the highest standards of oncology care and scientific rigor? This panel explores the multi-dimensional ecosystem forming around community-based oncology research — including the roles of trial networks, pharma, and health systems — and how each contributes to expanding access without compromising quality.

PANELISTS:

Philip Butera, Regional Assistant Vice President, Clinical Trials, Wake Forest Baptist Comprehensive Cancer Center, Atrium Health

Renee Smith, Head, Early Development Oncology Capabilities & Alliances, Johnson & Johnson

Kelly Franchetti, CEO, The Patient View

9:30 am PANEL DISCUSSION:

From Matching to Business Models: Redefining Provider Engagement in Clinical Research

PANEL MODERATOR:

Brian J. Slizgi, Partner, Pharma R&D Advisory, PwC

By examining novel frameworks and innovative engagement paradigms, we will highlight how strategic partnerships and aligned incentives can enhance participation, streamline processes, and accelerate the delivery of clinical trials. Attendees will gain insights into practical methodologies for shifting from transactional provider matching to sustainable, value-driven collaborations that underpin the future of clinical research.

PANELISTS:

Mimi Fenton, CEO, Cedar Health Research

Matt Ullum, CEO, Lynd Clinical

Gregory Licholai, Chief Strategy Officer, Syneos

Tony Clapsis, Managing Director, The Clapsis Group

Tim Joy, Global Development Transformation, Amgen

9:50 am

De-Risking Clinical Trials while Improving Speed, Control, and Confidence

Anna Berrier, Manager, Business Consulting, EY

Holli Anderson, Director, Clinical Trials Business Office, Moffitt Cancer Center

Sponsors depend on clinical trial sites for the data that determines the future of their assets, yet limited visibility and control over site operations creates systemic risk including delayed timelines, budget overruns, and enrollment underperformance. Technology has been the default solution but has failed to address the core issue: the operational firewall separating sponsors and CROs from sites. This session introduces a breakthrough operating model. By integrating expertise and support directly into site workflows, sponsors can de-risk trials, strengthen site partnerships, proactively resolve issues, and establish a feedback loop for true visibility and control. Join industry leaders as they share why this approach succeeds where traditional strategies fail, and what it means for the future of clinical trials.

10:15 amCoffee Break in the Exhibit Hall (Sponsorship Opportunities Available)

Fuel up and connect at SCOPE’s Coffee Break in the Exhibit Hall! Visit booths you haven’t seen, network with colleagues and exhibitors, and cast your final vote for the Best of Show Award—make your vote count!

11:10 am

Chairperson's Remarks

Krista Russell, Global Portfolio Leader, Evinova

11:15 am

Assessing Participant Motivation to Inform DCT Strategy

Leslie Carney, Senior Director, Patient Support Recruitment & Marketing, Elligo Health Research

Are virtual visits easier to attend for participants? Does the ease of no travel to a site equate to higher enrollment rates? As decentralized study designs have evolved, our industry has developed innovative ways to conduct scales and consenting and study requirements remotely. But with the advancements in capabilities, is interest and willingness from potential participants keeping up? Elligo Health Research has conducted over 20 decentralized/hybrid studies across 10 therapeutic areas in the US. Understanding participant motivation and barriers to appropriately plan strategies for enrollment is critical in all studies, and even more so when recruitment is dependent on external community referrals. Learn how Elligo Health Research has devised Enrollment Evaluation Criteria and uses the objective rating to guide solutions and strategy development.

11:40 am

A State‑of‑the‑Art Agentic Studio Engineered to Expedite and Elevate Clinical Data Management

Guarv Sharma, Life Sciences-Market Innovator, Health Sciences, Cognizant

Reinvented through Agentic Intelligence + human expertise, Curated AI Workbench engineered to expedite and elevate clinical data management. This session will highlight powerful results of a connected clinical ecosystem.

- AI agents that automate, accelerate, and optimize high‑value

- Clinical data management tasks Human expertise that ensures scientific rigor and compliance

- Integrated workflows that streamline study execution

- A next‑generation operational model that raises the bar for efficiency, quality, and scalability in Clinical Data Management, Study Set up and Data Review

12:05 pm PANEL DISCUSSION:

Expanding Research Participation through Local HCPs: Perceptions and Initial Strategies

PANEL MODERATOR:

Jane Myles, Vice President, Programs and Initiatives, Decentralized Trials & Research Alliance (DTRA); Vice Chair, The Myositis Association (TMA) Board of Directors

This session will share HCP perceptions about participating in clinical research as non-investigators. We will address the challenges and opportunities for HCPs to participate in clinical trials, aligned to the FDA guidance on decentralized clinical trials (DCTs) as well as Point of Care trials. We will share some initial strategies to include HCPs in trial conduct.

PANELISTS:

Shelly Barnes, Global Clinical Innovations and Digital Lead, UCB

Erica Jacobsen, Senior Director, Qualitative Team Lead, Konovo

Rebecca Kottschade, Administrator, Research Operations, Mayo Clinic

Brittany Niland, Senior Director, CTF Community Based Research, Eli Lilly & Co.

12:30 pm PANEL DISCUSSION:

Where Roads Are Long, and Access Is Limited: Rural Connections to Research in Action, Expanding Clinical Research Participation through Partnerships, Rural Infrastructure, and Decentralized Solutions

PANEL MODERATOR:

Dixie D. Thompson, Director, Research & Science, University of Utah CTSI & the Trial Innovation Network, Vanderbilt

Rural Connections to Research (Utah RCR) has established a six-state phlebotomy network of contracted sites and ready access to virtual engagement tools. SCOPE attendees will discover how trust, tailored access to rural community health infrastructure, and technology can enhance rural representation in clinical trials. A panel of RCR partners will share real-world lessons, scalable strategies, and tools that enable study teams and partners to bring research closer to home.

PANELISTS:

Elizabeth Dam, PhD, Clinical Trial Liaison, West, AstraZeneca

Jake Krong, Research Director, Canyons and Desert Regions, Office of Research, Intermountain Health

Stacey Peterson, Research Manager, Clinical & Translational Science Institute, University of Utah

12:55 pmSponsored Networking Luncheon

Recharge, refuel, and connect over lunch—compliments of SCOPE sponsors! Enjoy a well-deserved break.

1:55 pmNetworking Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)—Best of Show Winner to be Announced

Recharge with coffee, dessert, and networking at SCOPE’s Exhibit Hall Break! Grab a sweet treat courtesy of our sponsors, visit Game Card Sponsors to collect stickers, and connect with colleagues before the afternoon sessions. Plus, don’t miss the announcement of the Best of Show winner!

2:30 pm

SCOPE around the World: Community, Connection, Celebration

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

2:40 pm Chairperson's Introduction:

Rethinking Trial Design

Matthew Rich, Principal, Pharma & Life Sciences Technology Leader, PwC US

2:42 pm KEYNOTE INTERACTIVE PANEL:

Clinical Is Not an Island: How Med Affairs and Access Can Transform Trial Success

PANEL MODERATOR:

Rosemary Rebuli, Global Head, Study & Site Operations, Novartis Pharma AG

Clinical operations leaders face increasing pressure to design trials that not only deliver clean data but also support downstream market success. This keynote panel explores how biopharma organizations can break down functional silos by integrating insights from Medical Affairs, Market Access, and field-facing roles like MSLs and CRAs. Panelists will discuss how early cross-functional collaboration improves protocol design, enhances site and prescriber engagement, supports feasibility, and aligns clinical development with real-world needs—ultimately creating a competitive edge. Learn how forward-thinking teams are redefining roles and relationships across the clinical-commercial continuum.

PANELISTS:

Karen Correa, PhD, Vice President, Development Operations, Boehringer Ingelheim

Raza Zaheer, Medical Head, Next Gen Immunology, North America, Sanofi

Jie Zhang, Head, Global Pipeline Market Access, CSL

3:12 pm

SCOPE Award Winners & Announcements (Sponsorship Opportunity Available)

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute

3:23 pm Chairperson's Introduction:

AI Adoption in eClinical Technology

Nagaraja "Sri" Srivatsan, CEO, Endpoint Clinical, Inc.

3:25 pm KEYNOTE INTERACTIVE PANEL:

Change Management for AI Adoption in Pharma Clinical Development Teams

PANEL MODERATOR:

Mike Sullivan, Executive Director, Global Development Operations Business Insights & Technology, Bristol Myers Squibb

AI is rapidly entering clinical development, but the real challenge isn’t the technology—it’s managing the people, processes, and culture shifts required for adoption. This panel will share practical lessons from pharma leaders on how to align stakeholders, upskill teams, and build trust in AI-driven tools across clinical operations. Discussion will focus on real-world strategies that move beyond theory to accelerate adoption, improve decision-making, and deliver measurable impact in drug development.

PANELISTS:

Chris Sinclair, PhD, Vice President, Global Therapeutic Platforms, AbbVie, Inc.

Susie Stephens, PhD, Head of Client Facing Technology R&D, Amgen

Demetris Zambas, Vice President & Global Head, Clinical Data Sciences, Pfizer Inc.

3:55 pmSCOPE's Closing Ceremony Booth Crawl (Sponsorship Opportunities Available). Last Chance for Exhibit Viewing

As the flame of another unforgettable SCOPE conference comes to a close, join us for our final reception, our infamous "booth crawl." Just like the Closing Ceremonies of the Games, we'll come together one last time to honor the moments of triumph, teamwork, and inspiration that made this week so special. Gather with friends, old and new, enjoy great food and drink, and celebrate the spirit of unity that connects us all. SCOPE 2026 may be ending, but the memories will last long after the torch goes out.

4:55 pmClose of Day

5:00 pmSCOPE out the Restaurants and Shops at Pointe Orlando, via Our Courtesy Shuttle* (Sponsorship Opportunities Available)

Enjoy an evening exploring the restaurants and shops at Pointe Orlando with transportation provided by our courtesy shuttle. Shuttles will run until 9:00 pm, with the last pick-up at 8:30 pm.

*Times subject to change. More details closer to the event.

Thursday, February 5

7:30 amRegistration Open

8:00 am

BREAKFAST PRESENTATION:

From Burden to Breakthrough: Innovative Strategies for Site and Patient Support

Shelby Stillwagon, Vice President, Decentralized Clinical Trials, ProPharma Group

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.

8:25 amTransition to Sessions

Part 2: eClinical Evolution

8:30 am

Chairperson's Remarks

Ruby Madison Ford, MPH, Research Analyst, Tufts Center for Study Drug Development

8:35 am

Evidence on Investigative Site Usage and Experience with Virtual and Remote Solutions

Roula Krayem, MS, Senior Research Analyst, Tufts Center for the Study of Drug Development (CSDD), Tufts University

The Tufts CSDD team has compiled recently published empirical evidence on investigative site use and experience with decentralized clinical trial components including their impact on clinical trial cycle times and enrollment performance. Quantitative data has been gathered and aggregated across several primary areas including technology adoption, workforce changes, IT infrastructure, and patient and staff satisfaction. This session will review evidence across these domains and summarize key takeaways and their implications.

8:50 am

Assessing Investigative-Site Experiences and Perceptions of the Use of Digital Tools

Ruby Madison Ford, MPH, Research Analyst, Tufts Center for Study Drug Development

This study examines the value of decentralized clinical trial (DCT) and digital solutions across global investigative sites. Findings show sites are independently investing in DCTs, signaling a need for sponsors to adapt partnership strategies. The research assesses current and emerging solutions for their ability to deliver richer insights, faster data access, improved patient participation, system integration, and enhanced data quality and integrity.

9:00 am

The DHT Tubestop: Creating a Playbook to Optimize DHT Use in Trials

Moulik Shah, Senior Vice President, Product, Data, and PMO Lead, Advanced Clinical

Lauren Tobe, Director, Regulatory Policy and Strategy, Eli Lilly and Company

This initiative team developed a comprehensive digital toolkit (DHT Tubestop) that streamlines the integration and implementation of digital health technologies in clinical trials, enabling optimized trial design, improved data collection modalities, enhanced patient engagement, and more efficient trial operations while ensuring compliance with regulatory requirements and data security standards.

9:25 am

AI Agent-Driven Approach to Informed Consent

Aparna Swaminathan, MD, Assistant Professor, Medicine, Duke University

Current methods for informed consent are inadequate, requiring substantial staff availability and using lengthy, non-informative documents, leading to poor understanding and engagement. Advances in technology, particularly generative AI, can drive the transformation of consent processes. We have developed and evaluated an AI agent driven consent process, for informed consent, which has potential to enhance transparency, understanding, and accessibility to clinical trials.

9:50 am

Beyond the Data Silo: Paving the Way for Future Digital Health Foundation Models with Scalable Cloud Infrastructure

Bahador Marzban, PhD, Principal Data Scientist, Innovative Medicine R&D, Johnson & Johnson

We present a systems-focused pipeline that converts population-scale biosensor-based actigraphy and PPG data (i.e., biosensor data) into reproducible, high-throughput training datasets for multimodal digital health foundation models. We implement a two-stage design: preprocessing and chunking the time series into binned window sizes using scalable EKS clusters, followed by distributed multi-GPU transformer training with a GPU-aware DataLoader and a time-series database to reduce I/O contention, sustain higher GPU utilization, and enable fast metadata-driven retrieval across multi-terabyte storage. In brief, this work emphasizes the infrastructure and data engineering trade-offs, as well as the operational patterns required to convert siloed time series into reproducible, high-throughput training pipelines—independent of model architecture or downstream performance metrics.

10:15 amFind Your Working Group

10:20 amInteractive Working Groups (Sponsorship Opportunity Available)

Step away from the slide decks and into the conversation.
After a full agenda of case studies, technical talks, and panels, SCOPE’s Interactive Working Groups offer a unique chance to roll up your sleeves and engage. Choose the topic that interests you—whether it aligns with your expertise or challenges you to think differently. Each group will explore a distinct theme using collaborative formats like hackathons, open innovation challenges, or problem-solving sprints. The only requirement: jump in and contribute.

IN-PERSON ONLY WORKING GROUPS:

Bringing Digital Health Measures to Life in Clinical Development

Viprali Bhatkar, PhD, Senior Director, Global Digital Health Lead, Bristol Myers Squibb

Bola Grace, PhD, MBA, Senior Director, Digital Biomarkers, GSK; Professor, University College London

Kai Langel, CEO, DEEP Measures

Sonia Ortner, Vice President, Digital Physiology Endpoint Strategy, Clario

Jared Worful, Head, Digital Health Technology, Real-World Science, Bayer

Discover how digital measures of health are developed and embedded into clinical development programs. Join us for an immersive, hands-on session that goes beyond theory. Through story-driven case studies, gamified panels, and live audience participation, you’ll experience the full journey of integrating digital measures - from concept to implementation.

What to Expect:

Real-world insights from top industry experts
Experience the process firsthand through interactive, decision-driven scenarios
Engaging storytelling that makes complex processes come alive
A chance to collaborate, compete, and co-create in a fun, educational setting

Whether you're a digital health innovator, clinical strategist, or just curious about the future of clinical trials - this session is your gateway to actionable knowledge and unforgettable engagement.

11:00 amNetworking Coffee Break

Take a break and reconnect at SCOPE’s Networking Coffee Break! Grab a cup of coffee, meet colleagues old and new, and fuel up before the next sessions. A perfect pause to spark conversations and make connections!

11:30 am

Chairperson's Remarks

Jie Shen, PhD, Research Fellow, Digital Science, AbbVie, Inc.

11:35 am

Operationalizing Digital Accessibility in Global Pharma

Stephen Framil, Corporate Global Head of Accessibility, Office of Corporate Accessibility, Merck & Co., Inc.

With the Americans with Disability Act (ADA) in place for over 35 years, the practice of digital accessibility has experienced a crescendo in recent years, and has become a central tenet in corporate values and ways of working. While the Web Content Accessibility Guidelines provide the global standards, the mobilization of a global pharma company to adopt accessibility best practices across its Information & Communication Technology (ICT) landscape throughout the drug development lifecycle can be quite overwhelming. Explore key components of a digital accessibility program, including where digital accessibility sits within a large global pharma company; steps to creating a digital accessibility policy and governance; and workstreams in a digital accessibility program.

12:00 pm PANEL DISCUSSION:

The Past as Prologue: What AI Innovators of Today Can Learn from DHT Innovators of the Past

PANEL MODERATOR:

Rachel Chasse, Associate Director, Digital Science, AbbVie

Today’s hottest innovation topic is AI in which the field is working hard to understand and build safe and effective solutions. It wasn’t too long ago when the hottest innovation trend was DHTs and some innovators may be feeling a sense of déjà vu. In this session, we will share lessons learned for the ‘new’ field of AI from the ‘less new’ field of DHTs.

PANELISTS:

Brinnae Bent, PhD, Faculty Director, Duke TRUST Lab, Duke University

Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe)

Kushal Gohil, Senior Vice President, Global Project Leadership & Launch Excellence, Parexel

Jie Shen, PhD, Research Fellow, Digital Science, AbbVie, Inc.

12:50 pmSCOPE Summit 2026 Adjourns

And that’s a wrap! Thank you for joining us at SCOPE Summit 2026. We hope you leave inspired, connected, and energized for what’s next in clinical trials. Safe travels, and we can’t wait to see you at the next SCOPE event!