Site Engagement & Enablement

2026 ARCHIVES

Collaborative Strategies to Improve Trial Execution

Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

The growing demand for sites with access to targeted patient populations—alongside increasingly complex protocols and the operational burden of proliferating technologies—requires new ways of working together to modernize clinical trials for the future. SCOPE’s 2nd Annual Site Engagement & Operations stream brings together sponsors, sites, and other critical stakeholders including CROs, technology providers, and patient-facing partners to explore how stronger collaboration, aligned incentives, and shared innovation can lead to more efficient, inclusive, and sustainable trial delivery. With a strong focus on education, alignment, and collaboration, this stream equips both sites and sponsors with the tools and perspectives needed to drive more efficient, inclusive, and sustainable trial operations.

Part 1: Collaborative Strategies to Improve Trial Execution

Part 2: Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

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: Collaborative Strategies to Improve Trial Execution

11:00 am Chairperson's Remarks

Cristin MacDonald, Vice President, Client Delivery, WCG

11:05 am

From Silos to Synergy: Driving Site Engagement through Integrated Technologies and Cross-Divisional Collaboration

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

Discover how integrated technologies and cross-divisional collaboration are reshaping site engagement in clinical trials. This session highlights strategies for breaking down silos, aligning tools and data, and building stronger site relationships. Learn how a unified approach can streamline operations, accelerate trial timelines, and improve outcomes for patients and stakeholders.

11:30 am

From Insight to Impact: Enhancing Site Engagement Strategies

Jennifer Blinn, Senior Director, Monitoring Excellence Global Process Owner, Clinical Study & Site Management, Bristol Myers Squibb Co.

Vidhya Gedela, Director, Patient & Site Engagement Products, Global Development Operations IT R&D Business Insights and Technology, Bristol Myers Squibb Co.

BMS is committed to transforming site engagement by listening to site feedback and implementing strategies that reduce process and technology burdens. Our focus is on enabling sites to prioritize patient care, resulting in smoother trial activation and conduct. In this session, “From Insight to Impact: Enhancing Site Engagement Strategies,” we will share key approaches that BMS is using to create a frictionless experience for the sites and accelerate the delivery of innovative medicines to patients.

11:55 am

New Approach to Site ID: Adding a Semantic Knowledge Platform to Solid Process Foundation

Katarzyna Moscicka, Head, Feasibility, PSI CRO AG

Guillaume Bartoletti, Manager Clinical Trial Operations, Sanofi Group

This session will explore a roadmap to site ID in one click. We’ll illustrate the importance of strong expertise-driven processes combined with the first-of-its-kind semantic knowledge platform. Using 30 years’ worth of operational data, a solid process foundation, and external data from 500k+ institutions and 3M sites, this new methodology reduces the industry’s 50% non-enrollment rate and empowers sponsors to accelerate timelines, cut costs, and boost trial efficiency.

12:20 pm

Cross-Functional Collaboration: Breaking Silos for Clinical Trial Success

Sunee Reiner, R&D Field Medical Director, Medical Affairs, Sanofi

Robert Robitaille, Associate Director, Team Lead I&I, US CSU, Sanofi

This presentation introduces a cross-functional collaboration model uniting Medical Affairs, Development, and Clinical Study Units to accelerate trials, engage KOLs early, and enhance risk mitigation. Attendees will gain actionable strategies to dismantle silos, foster joint accountability, and transform clinical operations into a dynamic, patient-centered ecosystem—delivering measurable impact across timelines, costs, and recruitment success.

12:45 pm

Faster, Better, Smarter: The ROI of Simulation in Clinical Trials

Jenna Rouse, Global Head, Clinical Operations, Simulations Plus, Inc.

In clinical trials, every dollar, data point, and day counts. This session explores how simulation-based training delivers measurable returns across the three metrics that matter most—cost, quality, and time. Learn how sponsors and sites are using immersive, adaptive learning and simulated protocols to reduce site/patient training burden, improve protocol compliance, and accelerate study timelines—without sacrificing quality. We’ll share case examples, data insights, and practical takeaways to help you turn training from a cost center into a competitive advantage.

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

Brook White, Vice President of Marketing & Commercial Operations, Sales & Marketing, CRIO

3:05 pm

Addressing Organizational Transformation for the Successful Adoption of EHR2EDC

Jo-Zahn Baxter, Director, Clinical Services, Axtria

Michael Forst, IT Capability Lead, R&D IT, AstraZeneca

Strategic insights from an experienced EHR2EDC implementation team that has successfully scaled the solution globally. This session moves beyond vendor roadmaps and technical specifications to address organizational change management and navigating cross-functional communication to maximize technology investments. Attendees will gain an understanding of the requisite stakeholders to engage, practical and effective communication strategies, and key asks for senior leadership.

3:30 pm

Automated Insight Generation for Clinical Site Operations Using Reasoning LLMs and GraphRAG

Mark F. Ciaccio, PhD, Principal AI Clinical Data Scientist, Information Research, AbbVie, Inc.

Derek Wang, PhD, Director Clinical & Performance Insights, AbbVie, Inc.

We created an AI virtual assistant to answer specific queries about site and study health to proactively monitor and improve clinical operations. This assistant uses GraphRAG with reasoning LLMs, including GPT5 and Claude-Sonnet, to extract meaningful insights from our internal clinical operations dashboards. Additionally, this automated application sends stakeholders weekly reports on key milestones and real-time notifications about causes-for-concern with suggested next-best actions for sites, countries, studies, and portfolios.

3:55 pm

Standardizing for Speed: The Blueprint for Modern Sponsor Site Partnership

Anusha Shetty, Senior Director, Strategy, Study Startup, Veeva Systems

Erin Stackowitz, US Innovation Lead, R&D, Sanofi

Chris Komelasky, CEO & CoFounder, SiteBridge Research Inc

Discover how leading biopharmas are strengthening their site partnerships through people, processes and platforms. Panelists from pharma, tech, and site networks will share how they are adopting standardized collaboration models-including restructuring roles and processes to foster genuine relationships and drive operational excellence.

Key Takeaways:

Relationship Focus: Dedicated roles to build trust and ensure seamless execution
Harmonization and Standardization: Streamlined surveys and unified systems to reduce redundancy.
Operational Excellence: Leveraging standardized technology to improve efficiency and accelerate site activation.

4:20 pm

Maximizing Impact for Sites Running Decentralized & Hybrid Clinical Trials

Georgena Barnes, Executive Director - MRN Project Management, Medical Research Network

Diego Martinez, Associate Director, Decentralized Clinical Trial Solutions, Parexel International

Decentralized and hybrid clinical trials enable sites to extend beyond traditional settings through community-based and in-home visit models. Maximizing impact depends on strong site engagement, early alignment, and clear communication to support efficient study start-up and delivery. Early engagement builds shared understanding of protocol needs and workflows, enabling practical, tailored solutions. These approaches have proven to expand geographic reach, reduce patient burden, improve retention and compliance, and help sites optimize recruitment, operations, and data quality while delivering patient-centered trials.

4:45 pm PANEL DISCUSSION:

Innovative Partnerships Delivering the Future of AI-Enabled Clinical Trials: Case Studies of Real-World Collaborations

PANEL MODERATOR:

Muhammed Idris, PhD, Co-Director, Digital Health & Medicine, Morehouse School of Medicine

The future of clinical trials is being built through bold collaborations between sponsors, research sites, and AI companies. This panel showcases real-world partnerships where cutting-edge technology is not just a tool, but a catalyst for reimagining recruitment, engagement, and outcomes.

PANELISTS:

Andres Alvarez, MD, PhD, Director, Clinical and Translational Medicine Division, Baptist MD Anderson Cancer Center

Kesley D. Holmes, DHA, MS, CCRP, Director of Clinical Research, United Digestive

5:10 pm

Powering Smarter Site Selection and Study Start-Up with Platform Technology

Catherine Gregor, Chief Clinical Trial Officer, Thought Leadership, Florence Healthcare

In this session, Catherine Gregor, Chief Clinical Trial Officer at Florence Healthcare, will share how organizations are rethinking site identification and feasibility using global site intelligence and AI-driven scoring to improve site selection. She’ll also examine the execution gap between selection and activation, showing how AI-first workflows reduce delays, risk, and manual handoffs while improving site readiness and speeding trial activation.

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

Scott Palmese, Executive Director, Site-Focused Solutions, Worldwide Clinical Trials

8:35 am

Aligning Stakeholder Priorities: A Unified Performance Framework for Clinical Trial Success

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

Carlos Orantes, CEO, Alcanza Clinical Research

Ian Wyglendowski, Vice President & Head, Strategic Clinical Partnering, UCB BioSciences, Inc.

Karen McIntyre, VP Global Site Alliance, Global Site Alliance, Parexel

Clinical trials involve diverse stakeholders with competing priorities, often causing misaligned incentives and communication gaps that delay patient access to therapies. This interactive panel unites sponsor, site, and CRO perspectives to explore a unified performance measurement framework. Panelists will share strategies for transparency, accountability, and alignment to accelerate access while ensuring quality and compliance.

9:00 am

Enhancing Site Engagement during Site Initiation Visits

Marie Kromplewski, RN, MSN, Associate Director, Clinical Capabilities Manager, Clinical Center of Excellence, Bristol Myers Squibb Co.

This session will introduce an innovative approach to conducting an engaging and successful Site Initiation Visit (SIV). The SIV serves as a crucial opportunity for the sponsor to connect with site personnel and convey key protocol information. This site- and patient-focused approach ensures a clear understanding of the protocol, expectations, and implications for their patients. Join the session to explore a streamlined agenda that focuses on providing critical protocol information improving understanding, allowing more time for questions, discussions, and building valuable relationships.

9:25 am PANEL DISCUSSION:

Sponsor-Site Collaboration: Tools, Data, and Processes for Enhanced Engagement

PANEL MODERATOR:

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

Join a panel of executive-level clinical trial leaders as they discuss how to move beyond transactional interactions toward long-term, value-driven partnerships across the clinical trial ecosystem. Through the lens of AI and digital innovation, panelists will share strategies for creating seamless trial rollouts, enhancing engagement with CROs, service providers, sites, and patients, and fostering trust that endures beyond a single study. Gain insights into how emerging technologies can accelerate collaboration, deliver measurable operational impact, and lay the foundation for sustainable, mutually beneficial relationships across all stakeholders.

PANELISTS:

Kristen Dopf, MHS, PA-C Principal Investigator, Suburban Research Associates

Vani Nilakantan, PhD, Founder and Managing Partner, Sikara Consultancy

Adam Penna, JD, Associate Director Clinical Operations, Merck

Ginger Switzer, Senior Vice President, Clinical Operations AMR Clinical

9:50 am

Meeting Sites Where They Are—Key Connections in Action

Kate Yawman, Director, Product Management, Advarra

Nick Spittal, Chief Operations Officer, Velocity Clinical Research

Richard Buckley, Director, Site Technology Solutions, Immunovant

Accelerating study start-up and improving operational outcomes requires sponsors to support sites within their established ways of working. This session explores how connected and easily accessible technology with aligned workflows can reduce inefficiencies, strengthen collaboration, and enhance visibility across study operations. Through real-world examples, we’ll highlight how greater technological harmony between stakeholders contributes to more efficient start-up, stronger engagement, and the realization of connected research.

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

Dylan Marais, Manager, Project Management, Summit Clinical Research

11:15 am

Protocol Complexity and the AMC-Pharma Disconnect: A HIRO-Inspired Blueprint for Collaboration

Christopher Herrick, Vice President, Research Technology, Mass General Brigham

This session explores how Academic Medical Centers (AMCs) and pharma sponsors can bridge gaps caused by increasingly complex trial protocols. Drawing on real-world experience and data-driven learnings from Mass General Brigham’s HIRO, we’ll highlight how early collaboration, feedback loops, and operational alignment reduce site burden and improves trial delivery. Site leaders will share challenges and introduce HIRO’s engagement model as a replicable, evidence-based framework for designing scientifically rigorous, operationally realistic trials.

11:40 am

Partnership for Progress—A Site/Sponsor Collaboration Success Story

Sean Cunningham, Senior Director, Study Site Engagement, Clinical Site Start-Up & Engagement, Takeda

Michelle Monosmith, Operations Administrator, Office of Clinical Trial, Mayo Clinic

Andrew Taylor, Associate Director Site Start-Up, Takeda

The cornerstones of any successful partnership are trust, transparency, and humility. In this session, representatives from Mayo Clinic and Takeda will share their approach to building a mutually beneficial partnership, which has led to reduced activation timelines, increased trial collaborations, and enhanced operational efficiency across both organizations.

12:05 pm PANEL DISCUSSION:

Scaling Trust: How Sponsors and Sites Move Beyond One-Off Success Stories

PANEL MODERATOR:

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

Successful sponsor–site collaborations are often celebrated as exceptions rather than standard ways of working. This panel brings together sponsor and site leaders to explore how trust-based partnerships can be scaled beyond individual studies or pilot programs. Building on real-world experiences, panelists will discuss the operating models, governance structures, and incentives required to sustain collaboration across portfolios, site types, and therapeutic areas. Attendees will gain practical insights into translating successful partnerships into repeatable, durable approaches that reduce site burden, improve execution, and support more efficient and sustainable trial delivery.

PANELISTS:

Sean Cunningham, Senior Director, Study Site Engagement, Clinical Site Start-Up & Engagement, Takeda

Christopher Herrick, Vice President, Research Technology, Mass General Brigham

Michelle Monosmith, Operations Administrator, Office of Clinical Trial, Mayo Clinic

Satish Singh, Senior Director, Strategic Partnerships, Global Development, Regeneron

12:30 pm

Driving Inclusive Clinical Research through Community Partnership: Reflections Collective, EmVenio, and Bristol Myers Squibb

Jeff Huntsman, Chief Commercial Officer, EmVenio

Natanya Candelario, Senior Director, Global Health Equity, Bristol Myers Squibb Co.

Despite growing awareness of the need for greater access in clinical research, many communities continue to face real barriers to participation — including historical mistrust, limited site access, and inconsistent engagement. This session will explore how community‑driven partnerships can meaningfully expand access, strengthen trust, and improve representation in clinical trials. Through grassroots engagement, embedded research infrastructure, and community‑led insights, this collaborative model has already demonstrated measurable impact in increasing awareness, willingness to participate, and diverse enrollment. Join us for a practical discussion on how sustained presence, authentic collaboration, and community‑centered strategies can advance health equity and reshape the future of inclusive research.

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: Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

8:30 am Chairperson's Remarks

Suzanne Harris, Senior Vice President, Marketing & Communications, SubjectWell

8:35 am

AI/ML-Based Strategies for Enhancing Equity, Diversity, and Inclusion in Randomized Clinical Trials

Shashidar Reddy Abbidi, Senior Manager, Clinical Data Management, Global Data Operations, Bristol Myers Squibb Co.

This session addresses the critical lack of diversity in clinical trials, which undermines the validity and fairness of medical evidence. Explore a novel AI/ML framework that operationalizes equity by using predictive modeling for targeted recruitment, adaptive designs, and real-time bias monitoring. Integrated with ethical safeguards, this approach ensures more representative and generalizable results. It offers a practical, responsible pathway to enhance both the scientific rigor and ethical integrity of clinical research, delivering more trustworthy evidence for all populations.

9:00 am

AI & Innovation in Clinical Trial Financial Management

Zahiah Gueddar, Senior Director Commercialization, Clinical Trial Financial Suite, IQVIA Technologies

Rajesh Patel, Senior Director, Product Management, IQVIA

Join industry leaders to discover how innovation is transforming clinical trial financial management and accelerating site and patient success. Hear firsthand about the key features and tools they’re most excited to implement and get an insider’s look at early improvements, including streamlined payment automation and stronger site outcomes. Whether you’re exploring AI in clinical trial financial management or seeking ways to boost results for sites and patients, this session delivers forward-looking insights and practical lessons from the field.

9:25 am

Optimizing Clinical Trials with Process Change and AI Innovation

Ophelia Mok, Senior Manager, Business Analytics and Insights, Global Development Organization, Takeda Pharmaceuticals, Inc.

Discover how quantifying patient burden through the Schedule of Activities (SOA) can transform protocol design at Takeda. This session will showcase how actionable insights on study burden informed early discussions, have guided complexity reduction, and minimized protocol amendments; explore strategies for leveraging competitive intelligence to optimize protocols and improve patient experience.

9:50 am

Empirical Evidence: Impact of Protocol Complexity on Operational Outcomes in Clinical Trials

Speaker to be Announced, PwC

Eduardas Valaitis, Managing Director Pharma & Life Sciences Analytics, PwC US

Mary Carroll, Director, Protocol Optimization, Clinical Acceleration & Performance, AbbVie, Inc.

We developed a multi-dimensional, quantitative framework to measure protocol complexity and applied it to digitized data from thousands of clinical trials conducted over the past decade. Using empirical models, we quantified how specific complexity dimensions influence enrollment speed and patient-initiated withdrawal. Scenario-based analyses demonstrate how targeted protocol simplification can improve operational performance and support more efficient prospective trial design.

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:

Simplify to Elevate: Designing Leaner, Smarter Clinical Protocols

Tuba Bas, PhD, Senior Director, Clinical Center of Excellence, Bristol Myers Squibb Co.

Ann Hegarty, Clinical Project Manager, Clinical Center of Excellence, Bristol Myers Squibb Co.

Vibhuti Mehta, Associate Director, PRC Lead, Bristol Myers Squibb Co.

Kissondra Morris, Associate Director, Protocol Review Committee Lead, BMS

This workshop brings together cross-functional teams to identify actionable ways to simplify protocols while preserving scientific integrity and regulatory rigor. Through collaborative exercises and real-world case examples, participants will explore strategies to reduce complexity, improve execution, and enhance the patient and site experience.

Participants will explore key focus areas, including:

Data Optimization – Identifying what’s essential and eliminating what’s not·
Reduce Burden – Crafting lean protocols that are easier to conduct & eliminate avoidable amendments
Smart Assessment Planning– Prioritize must-haves and eliminate noise, reduce complexity & ensure compliance

Together, we’ll explore ways to achieve leaner protocol design—turning simplification from a talking point into a systematic, sustainable practice.

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

Lydia Matombo, BSN, RN, PMP, ACRP-CP, Associate Director, Sumitomo Pharma

11:35 am PANEL DISCUSSION:

Site Input to DCT Use in Trials: Pathways to Protocol Input and Implementation Insights

PANEL MODERATOR:

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

Site adoption of DCT elements is critical to the success of driving these new methods to scale. Sites shared they often don't learn that DCT elements are included until the investigator meeting or initiation meeting. So, sites are not always set up to succeed using DCT elements. Two initiative teams have focused on how to include the site voice in protocol design and planning, by collecting high-level retrospective data and making clear how to gather prospective input. The aim is to help increase collaboration and insight to optimize best-fit DCT element use and implementation in trials.

PANELISTS:

Deena E. Bernstein, Vice President, Site Choice Account Development, TPS Global

Caroline Redeker, Chief Strategy & Commercial Officer, Advanced Clinical

Michelle Shogren, CEO & Owner, Innovate in What You Do!; former Senior Director of Innovation, Pharma R&D Clinical Operations, Bayer

12:00 pm

Optimizing Clinical Trials: Leveraging Payer Insights and Real-World Data for Recruitment and Site Planning

Shawn Edmonds, MBA, Executive Director & COO, CVS Healthspire Life Sciences Solutions

Yosef Khan, MD, PhD, Head of Product Strategy, CVS Healthspire Life Sciences Solutions

Sravanthi Mikkilineni, Clinical Trial Recruitment Delivery Lead, CVS Healthspire Life Sciences Solutions

In an industry where 85% of clinical trials fail to recruit or retain enough participants, precision targeting is crucial. This session explores how robust pharmacy and medical claims data – enhanced by payer insights – can be used to rapidly identify patient cohorts that match detailed study criteria and pinpoint where those patients reside. By leveraging real-world data and payer insights in study planning, sponsors can avoid protocol revisions and costly delays. Attendees will learn how a data-driven approach to clinical criteria and site selection ensures that only the most relevant patients enter the pipeline. Attendees will learn how data-driven clinical criteria and site selection ensures only the most relevant patients enter the pipeline, and they will understand how payer-informed targeting and outreach improves speed, scalability and overall trial performance.

12:25 pm PANEL DISCUSSION:

Many Voices, One Goal: Responsible AI in Clinical Trials across Stakeholders

PANEL MODERATOR:

Sharlene Carnegie, Senior Vice President, Engineering, Medidata Platform, Medidata a Dassault Systemes Co.

This multi-stakeholder panel, featuring perspectives from a sponsor, patient, and site, examines responsible integration of AI and its impact on clinical trials. Key topics include balancing innovation, privacy, and regulatory concerns, with practical implementation of AI tools. We’ll explore patient-centric strategies for trust, transparency, and equitable access, as well as industry best practices for data integrity and compliance that can streamline operations, enhance data, and improve patient engagement.

PANELISTS:

Shashidar Reddy Abbidi, Senior Manager, Clinical Data Management, Global Data Operations, Bristol Myers Squibb Co.

Andrea Downing, Founder, Light Collective

David M. Vulcano, Vice President, Research Compliance & Integrity, HCA Healthcare

12:50 pmTransition to Lunch

12:55 pm

LUNCHEON PRESENTATION: Orchestrating Site Management with Agentforce Life Sciences

Sharmin Nasrullah, General Manager, Life Sciences & Clinical, Salesforce.com, Inc.

Lorie McClain, Principal Strategic Solution Engineer, Salesforce.com, Inc.

Transform clinical operations from systems of record to systems of action. Discover how AI agents embedded in the workflow automate study start-up, feasibility, and site management. By reducing administrative burden and predicting operational and data risks, Agentforce Life Sciences connects sponsors and sites to replace manual hurdles with autonomous collaboration, accelerating trial timelines from enrollment to close-out.

1:25 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!