Data - 2026 Archive

2026 ARCHIVES

Integrating AI into Clinical Data and Analytics

SCOPE’s 17th Annual Data stream explores how data strategy, infrastructure, and advanced analytics are reshaping clinical trials. From streamlining data collection and integration to enabling scalable AI applications, industry leaders will share practical solutions for breaking silos and accelerating decision-making. Sessions will focus on real-world use cases, governance models, and emerging tools that support innovation across the clinical trial lifecycle.

Part 1: Clinical Data Strategy

Part 2: Integrating AI into Clinical Data and Analytics

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: Clinical Data Strategy

11:00 am Chairperson's Remarks

Ellis Butterfield, CTO, Corporate, Sitero

11:05 am

Making a Unified Data-Management Platform a Reality

John Finn, Executive Director and Inflammation & Immunology-RAE TA Lead, Clinical Data Scientist, Pfizer Inc.

Ralph Russo, Executive Director, Global Head, Clinical Data Collection Strategies, Pfizer Inc.

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

This session will explore Pfizer’s journey to create an end-to-end data management, reporting, and analytics platform to support traditional and decentralized clinical trials with true real-time access to data throughout. Hear how co-developing a new solution solved for true simplified EDC build, Direct Data Capture, non-CRF Data streamlined Acquisition, tiered query management, dynamic SDV to support study RBM, Advanced Reporting and Analytics for sponsor, study monitors and sites themselves, and SAE reporting automation eCRF Capture and flow to safety system.

11:55 am

Empower Your Workforce and Accelerate Your Trials with Agentic AI

Laura Acosta, Vice President, Product Management, eClinical, Anju Software

This presentation will discuss:

Enhancing and Scaling effectiveness through AI
Elevate your star performers by offloading repetitive, manual tasks (e.g., EDC trial setup).
Agentic AI powered Virtual assistants free up your experts to focus on higher-value work and scale their expertise across multiple trials, teams and decisions.
Embracing the power of AI

12:07 pm

State of the Clinical Trial Landscape—Key Trends and Expectations for 2026

John Rose, Senior Vice President, Healthcare, GlobalData Plc

Decode Trial Growth: Understand which types of clinical trials truly increased in 2025, factoring in reporting lags, start-date shifts, and withdrawn studies. Understand the true market size. Know Where to Focus: Get clarity on growth by therapy, modality, geography, and sponsor type to align your focus and competitive advantage with the clinical research market shift. Spot Signals Early: Learn how hirings, patents, and other data reveal opportunity before it’s reported in clinical trial registries and products. Prepare for 2026 and Beyond: Understand forecasts for 2026 and beyond to align sales, competitive intelligence, capacity, and strategy.

12:20 pm

Dataverse Unleashed: Empowering Global Therapeutics with AI-Ready Data

Gian Prakash, Director, Data & Analytics, Information Research, AbbVie, Inc.

Discover the transformative power of Dataverse, an integrated platform designed to revolutionize AI applications in global therapeutics through AI-ready data. This presentation will highlight real-world use cases where Dataverse effectively bridges the gap between proof of concept and large-scale AI use-case implementation, enabling innovative therapeutic strategies and enhancing patient outcomes globally with robust and actionable AI-ready datasets.

12:45 pm

Innovative Models for Aligning Incentives for Clinical Trials in the Age of AI

Ariel Katz, CEO & Co-Founder, H1

Robert Stevens, Head, Clinical Development Procurement, Bristol Myers Squibb

Ariel Katz and Robert Stevens are thrilled to be teaming up for a fireside chat! They're excited to bring their combined expertise to the stage and create a dynamic, conversational experience.

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

Brandon Rufino, Director, AI for Clinical Trial Design, Sanofi

3:05 pm

AI-Ready Data is a Business Strategy, Not a Tech Problem

Victoria Gamerman, PhD, RWD Insights

In life sciences, the promise of AI can be stalled by data that lacks context. We'll discuss a human-centered framework for building a robust business strategy around your data assets. We will explore a trifecta for success: 1) establishing deep context with knowledge graphs, 2) deploying analytics that predict outcomes and de-risk development, and 3) translating technical capabilities into clear business cases and measurable ROI to drive true, human-centered transformation.

3:30 pm

Beyond Seeing to Chatting with Our Portfolio: Accelerating Clinical Decision-Making with Performance Central

Jacqueline Habib, Senior Director, Drug Development Portfolio Management Insights, Bristol Myers Squibb

Leyla Rich, Senior Director, R&D Portfolio Operations, R&D Business Insights & Technology, Bristol Myers Squibb

Discover how Performance Central and its embedded IRIS chatbot are revolutionizing R&D portfolio operations at BMS. This enterprise platform gives teams instant, conversational access to data on over 250 projects and 300 active studies—empowering faster, smarter decisions. We’ll share lessons learned from centralizing data and harmonizing metrics, highlight our ‘chat with’ rollout and user feedback, and reveal future milestones for scaling conversational AI across global clinical portfolios.

3:55 pm

Beyond the Hype: What It Really Takes to AI-Author Clinical Trial Documents

Jef Benbanaste, Senior Vice President & Head, Product Management Veridix AI, Emmes Group, Inc.

Nageswara Rao Kollu, Senior Director, Apellis Pharmaceuticals, Inc.

Generative AI is gaining rapid attention in clinical research, but turning promise into production remains a challenge, especially for clinical trial documentation, where accuracy, traceability, and regulatory rigor are non-negotiable. In this session, Jef Benbanaste, SVP & Head of Product at Veridix, shares real-world lessons learned and success stories from applying AI to clinical trial document authoring across protocols, statistical analysis plans, clinical study reports, and operational plans. Drawing from live deployments, the talk explores what it takes to move beyond experimentation, including the role of intelligent agents, curated knowledge bases, and content- and context-aware generation in creating scalable, reviewable, and compliant authoring workflows. Attendees will leave with a clear understanding of what has worked, what hasn’t, and the practical design and organizational decisions that matter most when adopting AI for clinical trial documentation.

4:20 pm

Elevating Clinical Data Management: Using Next-Gen AI and Automation to Streamline Data Collection & Review Processes

Hitesh Amin, Senior Manager, Engineering, AI & Data, Deloitte Consulting LLP

In this presentation, we explore how AI and Automation plays a key role in streamlining clinical data management processes, focusing on data aggregation from multiple sources, improving data review, medical monitoring processes, and query management. We will also talk about how a strong data foundation is essential to enabling these capabilities at scale. By the end, you will see how these innovations can lead to more efficient, reliable, compliant, and scalable clinical data workflows.

4:45 pm

Powering Clinical-Study Innovation through Low-Code Platforms and Product-Centric Governance

Keith A. Wilson, Associate Director, Product Management, Global Development IT, Regeneron Pharmaceuticals, Inc.

Regeneron’s GD-IT Enabling Technologies team established a Power Platform Center of Excellence and adopted a product-centric delivery model to streamline data capture and oversight for clinical trial operations. Strategic investments in premium licensing enabled scalable, compliant solutions to centralize study tracking and integrate with enterprise systems to support protocol development and milestone management.

5:10 pm

Redefining Clinical Operations: The Power of Integrated Agentic AI Platform in Action

Sowmya Ballakur, Vice President, Product, Oracle Health & Life Sciences

Jason Rizzo, Group Vice President, Oracle

Clinical development is often slowed by fragmented systems and inefficiencies in patient recruitment, site selection, trial optimization, and continuous monitoring. We present an AI-enabled life sciences solution that integrates diverse data sources to streamline operations. By leveraging predictive and reasoning models, automated insights, and real-time performance tracking, it enhances recruitment, optimizes site selection, and proactively monitors trials, resulting in faster timelines, improved compliance and ultimately bringing new therapies to patients more quickly and safely.

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

Anthony Mikulaschek, Vice President, Patient Commercial Strategy, IQVIA Technologies

8:35 am

How Causal AI, Powered by Data, Is Revolutionizing ClinOps: Optimized Site Selection and Real-Time Dashboards

Raviv Pryluk, CEO, PhaseV Trials Ltd.

PhaseV ClinOps Platform brings precision to site selection by integrating multi-modal patient- and site-level data with causal AI, enhancing diversity and boosting efficiency. Real-time dashboards provide continuous oversight of recruitment, adherence, and site performance, while predictive “what-if” analytics enable proactive decisions, reduce risk, and support adaptive trial execution from day one.

9:00 am

Human+AI Driven Data Review Plan: A Black Hole Experiment

Sanjay Bhardwaj, Executive Director, Head of Clinical Data Technologies, AbbVie, Inc.

Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.

As the clinical research industry steadily advances its adoption of AI-driven anomaly detection for clinical data, it is increasingly clear that artificial intelligence, while powerful, remains only one component of a comprehensive data review strategy. This session introduces a practical framework for developing an integrated clinical data review plan where inputs from both human experts and AI systems are systematically combined. Leveraging standards libraries, data review plan (DRP) libraries, and study protocols, we will explore methodologies to harmonize technology-driven insights with clinical judgment. Attendees will gain actionable guidance on creating robust data review plans that optimize accuracy, compliance, and efficiency harnessing the complementary strengths of AI models and human expertise.

9:20 am

Next-Generation Analytics for Feasibility Leveraging AI Agents for on-Demand Insights

Ray Zhong, PhD, Associate Director, Data Technologies & Analytics Solutions, Data & Analytics, Otsuka America Pharmaceuticals, Inc.

Traditional approaches to feasibility analytics tools focus on the creation of rigid dashboards fit for purpose to specific metrics. In this work, we aim to change the way that study teams interact with analytics and insights for protocol feasibility and site profiling analytics by enabling an AI-driven user interaction that focusses on generating targeted insights based on the specific user's intent and preferences.

9:35 am

Leveraging a Data-Mesh Framework in Clinical Trials

Vishal Janani, Director, Digital Clinical Operations, BeOne Medicines

Beenu Kapoor, Executive Director, Global Clinical Operations, BeOne Medicines USA Inc.

9:50 am

How to Build an AI Study-Simplification System

Barrie Nelson, President, Nurocor

Angelo Tran, Manager, AI Products, Nurocor

Michelle Guo, Senior Manager, Deloitte

Michael Cantor, VP, Data Technology & Innovation, Regeneron Pharmaceuticals Inc

In today’s rapidly evolving landscape, digitalization is more than just going paperless—it’s about transforming the way we operate, connect, and deliver value. At the heart of this transformation is Artificial Intelligence (AI), a powerful force driving automation, insight, and innovation. As we digitalize our workflows, data, and services, we unlock the potential for AI to enhance decision-making, streamline operations, and personalize experiences at scale. Together, digitalization provides the foundation and AI delivers the intelligence—enabling smarter systems, more agile organizations, and deeper customer engagement. By embracing both, we’re not just adopting new technologies—we’re building a future where efficiency, creativity, and data-driven efficiencies go hand-in-hand.

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

Doug Bain, Consulting Partner, Clinflo

11:15 am

Agentic AI Meets Digital Trials Intelligence: The Future of Study Design, Execution, and Oversight

Shakthi Kumar, Chief Strategy and Business Officer, EDETEK, Inc.

Agentic AI and digital trial modernization are redefining how studies are designed, executed, and overseen. This session shows how Agentic AI combined with DSL powered rule packs creates intelligent, deterministic, adaptable, automated, and highly explainable trial environments. By converting protocol elements into executable clinical logic and integrating real time data from an R&D cloud, study teams gain continuous oversight, earlier risk detection, streamlined safety review, and faster decision cycles. Discover how these capabilities unify data flows, support confident operational decisions, and improve quality across the clinical lifecycle.

11:40 am

Leveraging a Data-Mesh Framework in Clinical Trials

John Jones, Senior Vice President, Head Life Sciences Consulting, Entitech Solutions, a TANDYM Company

Vishal Janani, Director of Digital Clinical Operations, BeOne Medicines USA, Inc.

Beenu Kapoor, Executive Director, Digital Clinical Operations, BeOne Medicines USA, Inc.

Data mesh, a decentralized architectural framework that enables domain teams to own and govern their data while facilitating cross-domain analysis, addresses the unique challenges of clinical trial operations by democratizing access to trial data while maintaining strict regulatory compliance and patient privacy standards. Data mesh, a decentralized architectural framework that enables domain teams to own and govern their data while facilitating cross-domain analysis, addresses the unique challenges of clinical trial operations by democratizing access to trial data while maintaining strict regulatory compliance and patient privacy standards.

12:00 pm PANEL DISCUSSION:

The Great Data-Capture Debate: EHR, eSource, and Traditional Approaches

PANEL MODERATOR:

Doug Bain, Consulting Partner, Clinflo

In an era of digital transformation, the question remains: What is the best way to capture clinical trial data? This interactive session brings together two expert panels for a dynamic and thought-provoking discussion. First, a Vendor Panel will represent distinct approaches to data capture. Then, a Sponsor Panel comprised of experienced industry professionals will respond. Ultimately, this panel will illuminate what truly matters from an operational and strategic perspective.

PANELISTS:

Derk Arts, Founder & CEO, Castor

Zach Taft, CEO, IgniteData

Manny Vazquez, Senior Director, Clinical Data Strategy, Veeva Systems

Michael Ward, Senior Director, eSource Capabilities, Eli Lilly and Company

Michael Wenger, Chief Innovation Officer, CRIO

12:30 pm

The Hidden Cost of Misaligned Protocols—and How to Fix It

Tracy Ohrt, Director, Clinical Operations, Clinical Research Solutions, Optum

Eighty percent of clinical trials fail to meet enrollment targets, often due to misaligned eligibility criteria and protocol design that doesn’t reflect real-world clinical practice. By leveraging real-world data (RWD) during protocol development—especially when defining inclusion and exclusion criteria—sponsors can reduce costly amendments, improve recruitment efficiency, increase patient diversity and increase the likelihood of meeting their target enrollment. This is the critical moment—before trial initiation—when thoughtful design can make or break a study. A holistic review involving clinical stakeholders ensures criteria are interpretable within EHR systems and aligned with how care is actually delivered. Understanding how diagnoses are documented, labs are ordered, and procedures are performed helps sponsors create protocols that sites can easily interpret, execute effectively, and ultimately improving trial outcomes.

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: Integrating AI into Clinical Data and Analytics

8:30 am

Chairperson's Remarks

Valerie Balosso, Director, Data Management, Infectious Diseases, GSK

8:35 am

Yes, You Can (Digitalize That): Streamlining Study Design through Protocol Digitalization

William Illis, Global Head, Collaboration & Technology Strategy Clinical Development, Novartis Pharmaceuticals

Donald Jennings, Senior Director, Digital Trial Foundations and Patient Engagement, Eli Lilly and Company

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

9:00 am

From Trial Data to Confident Decisions: AI-Enabled Clinical Oversight

Christie Quarles, Clinical Analytics Product Manager, Clinical Analytics, Revvity Signals

Clinical teams face growing trial complexity, fragmented data, and increasing pressure to make timely, defensible decisions. This session explores how an integrated, data-driven approach to clinical oversight can simplify review workflows and improve visibility across data, medical, and operational review. Learn how governed, AI-enabled analytics, including natural-language custom listings, can reduce manual effort, strengthen collaboration, and support consistent, transparent decision-making across the trial lifecycle

9:25 am PANEL DISCUSSION:

How to Navigate the Data-Science Transformation

PANEL MODERATOR:

Valerie Balosso, Director, Data Management, Infectious Diseases, GSK

With the introduction of AI in Data Management and its significant impact on efficiency and decision-making, traditional Data Management must evolve toward a more analytics-driven, risk-based approach. This panel will explore the transformative shift from traditional Data Management to Clinical Data Science, highlighting the necessity to use centralized statistical monitoring, the importance of change management, workforce upskilling, and fostering collaboration to ensure the seamless integration of innovative methodologies.

PANELISTS:

Lynne Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs

Miguel Lemaire, PhD, Associate Director, Oversight Data Management, GSK

Shawntel Swannack, Regional Director (Americas), Analytical Monitoring, Data Management & Central Monitoring, Integrated Data Analytics & Reporting (IDAR), Johnson & Johnson

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 GROUP:

Humans, Meet Your Co-Panelists: AI Takes the Mic in Clinical Trials

Munther H. Baara, Vice President, Product Strategy & Innovation, EDETEK, Inc.

Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)

Everyone's talking about AI, but what happens when AI joins the conversation? In this live, interactive format, two role-based AI co-panelists, a Patient Burden Auditor and a Site Coordinator Advocate, join Munther Baara and Craig Lipset to pressure-test a clinical trial operational challenge chosen live by the audience (such as protocol complexity, enrollment drag, data flow friction, or RBQM signal/noise).

This isn't a typical panel; it's a working session. We'll quickly "autopsy" what's breaking today, make assumptions explicit, surface tradeoffs, and rebuild a practical path forward across process, protocol, and data. AI outputs are treated as hypotheses, the humans challenge feasibility, risks, and incentives in real time.

You'll leave with a one-page Field Guide tailored to the selected problem: likely root causes, actionable fixes, ownership prompts, and a primary metric with guardrails you can use Monday morning, whether you leave inspired or skeptical.

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

Alex Liu, Director of Product Management, Life Sciences AI Data Platform

11:35 am

Building a Transformative, AI-Driven Analytics Capability for Clinical Trial Insights

Omkar Dasari, Senior Technical Product Manager, Data & Analytics, Amgen

James Vernille, PhD, Director, Clinical Systems & Analytical Reporting, Global Development Operations, Amgen, Inc.

At Amgen, we are transforming our analytics ecosystem with AI-driven tools that enable near real-time, self-service insights for Global Development stakeholders. Our next-generation analytics engine features a rebuilt metrics platform, centralized data governance, and a streamlined dashboard landscape leveraging Power BI with Co-Pilot and custom AI interfaces. By implementing AI/ML bots and natural language queries, we are shifting from static reporting to a dynamic, AI-driven experience.

12:00 pm

From Proven Results to Product Vision: Advancing Clinical Trial Data Exchange with IgniteData Archer

Joe Lengfellner, Chief Product Officer, IgniteData

Clinical trial data exchange has long limited the pace of innovation in research. This session explores how IgniteData Archer is redefining what’s possible, drawing on proven results from live trials at Memorial Sloan Kettering Cancer Center. Presented by Joe Langfellner, IgniteData’s Chief Product Officer, the talk connects real-world impact to a forward-looking product vision—explaining why Archer’s success led him to join IgniteData and how he and the team are shaping the future of clinical trial data exchange.

12:13 pm PANEL DISCUSSION:

Transforming Clinical Data Analytics with Agentic GenAI

PANEL MODERATOR:

Sina Djali, Managing Partner, Axcellion.ai

This panel explores how Agentic Generative AI (GenAI) is reshaping clinical data analytics by enabling autonomous and adaptive systems that streamline data processing, uncover complex patterns, and generate actionable insights. The discussion will address the opportunities and risks of integrating Agentic and Applied GenAI into regulated clinical research environments, highlighting their potential to drive innovation while maintaining data integrity and patient safety.

PANELISTS:

Bhargava Reddy, PhD, Senior Director, Advanced Insights and Solutions, Janssen

Richard Young, Chief Strategy Officer, CluePoints

Donald Jennings, Senior Director, Digital Trial Foundations and Patient Engagement, Eli Lilly and Company

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!