Quality & Monitoring - 2026 Archive

2026 ARCHIVES

As clinical trials modernize, the way that companies think about quality and risk in the design and conduct of a study must evolve as well. SCOPE’s 12th Annual Quality & Monitoring stream will provide an opportunity for clinical operations leaders to exchange best practices, case studies, and in-depth strategies for integrating a risk-based approach throughout the clinical research cycle, from study design to monitoring activities. Industry leaders in RBQM will come together alongside changemakers from other functional areas to collaboratively work towards integrating quality throughout clinical study. The program will also feature new technologies and innovative ways that studies are monitored and analyzed. This program will explore ways of leveraging RBQM technologies to achieve study plan goals, the impact of ICH E6 R3 on study conduct, the application of AI tools and data analytics to power a risk-based approach, and key insights for regulatory compliance.

Part 1: Risk-Based Quality Management

Part 2: Central Monitoring and Signal Detection

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: Risk-Based Quality Management

11:00 am Chairperson's Remarks

Jonathan Rowe, Principal, ZS

11:05 am

Quality in the Time of AI: Elevating Quality Culture amid Technological Change

Rich Bowling, PD Quality Excellence Digital Team Lead, Genentech

Jennifer Hebert, Principal Quality Lead, Quality Assurance Programs, Roche/Genentech

Mandy White, Senior Quality Lead, Roche/Genentech

This session addresses how the integration of AI is reshaping the quality landscape for organizations seeking to leverage the latest advances to reap efficiencies in quality professionals’ work. We’ll explore challenges like data quality, bias, transparency, and balancing technology with human oversight, alongside validating AI outputs and preserving human judgment. Attendees will gain actionable strategies, learn how to start effectively, and navigate talent and culture questions as AI adoption expands.

11:25 am

Why Some Risk Assessments Work—And Others Don't

Kristin Stallcup, MS, Director, RBQM Operations, Takeda

We agree that risk assessment is foundational to the clinical trials—but let’s be honest, not all risk assessments feel meaningful. Some fall flat, while others unlock the power of cross-functional insight. This PHUSE working group came together to understand why, and to share practical ways to make every risk assessment consistently effective—including how AI can help us get there.

11:40 am

Embedding RBQM Principles to Transform Clinical Trials: The Novartis Journey

Ann Meeker-O'Connell, Executive Director, Monitoring Excellence Head, Novartis

At Novartis, Risk-Based Quality Management (RBQM) Quality by Design (QbD) has proven its value through a successful pilot, demonstrating measurable benefits—streamlining protocol development and enabling proactive risk management for early adopters, with the Risk Surveillance lead as a strategic enabler. Building on this foundation, Central Monitoring marks the next phase of the RBQM journey—leveraging data-driven insights to address the growing complexity of modern trials. This evolution is not just procedural—it’s cultural. Through targeted change management, Novartis is shifting study teams’ mindsets toward quality-focused, risk- and data-driven practices. RBQM QbD and Central Monitoring are now embedded as integrated pillars of protocol development —from trial design through execution—enabling more reliable and higher-quality clinical trials. This is the story of transformation from pilot to scale-up: redefining how trials are designed, conducted, and completed—with a quality mindset at the core and RBQM principles as the foundation for sustainable excellence.

11:55 am

The New Risk-Based Data Ecosystem: A Practical Guide to Integrating RBDM and RBQM for the E6(R3) Era

Vera Pomerantseva, Director, Product Management, eClinical Solutions

The release of ICH E6(R3) Annex 1 in January 2025 and EMA implementation in July 2025, introduced a new era of risk-based management and oversight in clinical trials. The guidance reinforces proportionate, criticality-driven approaches across trial activities related to cross-functional monitoring and review. Learn how to integrate risk strategy defined in RACT into cross-functional monitoring and review activities, gain portfolio and vendor oversight, and support compliant, efficient trials.

12:20 pm PANEL DISCUSSION:

Cross-Functional RBQM: Streamlining Site Engagement and Integrated Data Review

PANEL MODERATOR:

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

Risk-Based Quality Management is reshaping how sponsors interact with study sites, emphasizing strategic, targeted engagement that minimizes unnecessary queries. As data visualization and technology expand, cross-functional collaboration between safety, quality, and medical teams becomes essential. This panel will explore integrated data review strategies, leadership coordination, and approaches to reduce duplication while ensuring study quality.

PANELISTS:

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

Kristi Koontz, Vice President, Global Clinical Operations, Daiichi Sankyo US

Pinal Patel, Head, Patient Site Engagement & Feasibility, Medical Affairs, Johnson & Johnson Innovative Medicine

12:45 pm

The Future of RBQM for Early Phase Studies Starts Here

Duncan Hall, CEO & Founder, TRI

RBQM is essential for protecting patient safety and driving quality by design principles across all phases of clinical research and is arguably more important in early phase studies than any other. Yet in practice, the application of RBQM to early phase is highly inconsistent, often relying on manual processes and individual judgement instead of structured processes, supported by compliant technology.

Join Duncan to discover:

Where the gaps are
What's at stake
How to move forward

You’ll leave with actionable insights on how flexible, structured monitoring can:

Improve visibility into what's been reviewed, by whom and why
Drive efficiency and consistency without rigidity
Enable better decision-making and prioritization across diverse study designs

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!

2:10 pmSpecial Book Signing

Risk-Based Quality Management: The Ultimate Clinical Researcher’s Guide

Authors: Artem Andrianov, PhD & Johann Proeve, PhD

Location: Booth #615

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

Jennifer Stewart, Executive Director, Clinical Data Sciences, Premier Research

3:05 pm

Digital Disruption: Transforming Inspection Readiness and Quality in Clinical Trials

Kevin Richards, Senior Director, Clinical Quality, AstraZeneca

Mark Volk, Director, Clinical Quality, AstraZeneca

Digital transformation is revolutionizing inspection readiness in clinical trials. By implementing automated study storyboards and inspection readiness solutions for study teams, organizations can provide real-time, comprehensive overviews of trial data, ensuring consistency and transparency. This approach streamlines preparation for audits and inspections, reduces manual errors, and enables proactive quality management.

3:30 pm

Turning Signals into Strategy: Data‑Driven RBQM to Optimize Monitoring at Site, Study, and Portfolio Levels

Łukasz Bojarski, Executive Director, Centralized Monitoring & Risk-Based Quality Management, AstraZeneca

This presentation demonstrates how data‑driven RBQM transforms oversight from reactive review to proactive, scalable risk management. Examples will illustrate how insights translate into right‑sized monitoring plans, more robust signal detection, and consistent quality improvements across the portfolio and enterprise.

3:55 pm

From Strategy to Scale: Roche’s Enterprise RBQM Journey to

Improve Speed, Efficiency, and Probability of Technical Success (PTS)

Gregory Long, RBQM Innovation & Tech Process People Leader, Roche

Sharma Ramanathan, Principal, R&D Excellence, ZS Associates

As clinical development portfolios grow more complex, organizations must move faster without compromising quality or the probability of technical success. In this session, Roche and ZS will share Roche’s end-to-end RBQM journey: the strategic rationale, the operating model transformation, and the technology foundation required to scale RBQM across one of the largest clinical trial portfolios in the industry.

4:20 pm

The Rise of the Central Monitor 3.0: Are You Ready?

Olgica Klindworth, Vice President, Clinical Data Studio, R&D, Medidata, Dassault Systemes

Jenn Krohn, MS, Director, RBQM, Clinical Operations, Gilead Sciences. Inc.

Shawntel Swannack, Regional Director, Analytical Monitoring & Data Quality Assurance, Johnson & Johnson Innovative Medicine

Susan Green, Director, Clinical Data Management, PPD Part of Thermo Fisher Scientific

What is the role of the central monitor of the future? Today they face growing challenges—fragmented data and tools, manual processes, and internal change management obstacles . This panel explores the rise of the Central Monitor 2.0 - how automation, AI, and ICH E6 R3 driven RBQM evolution is transforming centralized monitoring. Discussion includes the need for a centralized ‘quality command center’, better unification of monitoring as a holistic concept, and the evolving skill set for future central and onsite monitors.

4:45 pm PANEL DISCUSSION:

From Guidelines to Game-Changer: What Will It Take to Implement RBQM with Agentic AI?

PANEL MODERATOR:

Nechama Katan, Chief Wizard, Wicked Problem Wizards

ICH E6(R3) calls for a proportionate, risk-based approach to trial oversight, ensuring that “processes, measures and approaches are proportionate to the risks to participants and to the importance of the data collected." Risk-Based Quality Management (RBQM) has long promised to make this vision a reality, but its full potential has been limited by fragmented data, manual processes, and slow decision cycles. Now, agentic AI—AI systems capable of perceiving, reasoning, and autonomously taking actions within defined constraints—offers the possibility of continuous monitoring, dynamic risk assessment, and proportionate intervention at scale. But what would it take to responsibly implement such systems in a regulated, high-stakes environment? This panel brings together industry leaders to talk about how agentic AI can be aligned with ICH E6(R3)'s risk-proportionate principles; what guardrails are needed to ensure trust, transparency, and compliance; how we can integrate AI-driven insights into human decision-making; and where the real opportunities—and the real limits—of automation are in RBQM today. Expect a lively, reality-focused discussion that goes beyond hype, drawing on the collective expertise in the room to map a realistic path from concept to compliant, value-adding deployment.

PANELISTS:

Bo Maach-Moller, Vice President, Risk Based Quality Management and Central Monitoring, Novo Nordisk AS

Jenn Krohn, MS, Director, RBQM, Clinical Operations, Gilead Sciences. Inc.

5:10 pm

Closing the Last-Mile Adoption Gap to Achieve Clinical Trial Excellence

Vasant Shetty, Regional Head, Whatfix

Even the best-designed SOPs fall short when clinical teams struggle to use the digital systems that support trial execution. Across global studies, everyday usability challenges within Clinical Trial Management Systems (CTMS) and Electronic Trial Master File (eTMF) systems often lead to inconsistent execution, avoidable deviations, and increased monitoring burden. This session explores how to solve for the “last-mile adoption gap” and address the disconnect between documented processes and how users actually navigate complex clinical technologies hence, improving clinical quality, compliance, and operational efficiency.

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 (IN-PERSON ONLY)

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

Danilo Branco, Associate Director, Risk Based Quality Management Lead, BeOne Medicines

8:35 am

RBQM Needs Oversight - A Practical Approach

Johann Proeve, PhD, CSO, Cyntegrity

Bethann Schrader-Giancarlo, Director, Data Management, Pharvaris

SCOPE Europe 2024 led to the formation of a group of industry experts called the mindsON RBQM Expert Working Group who met through 2025 to discuss the challenges of RBQM Oversight, i.e. how can one ensure that RBQM has been implemented properly. They have now published learning resources to assist the industry with right-sizing the oversight effort for a trial and being able to shift the level of oversight up or down dependent on performance. Their focus has been primarily on oversight of RBQM when outsourced but the same learning resources can be used when RBQM is maintained in-house. Come along and find out where to access the resources, why they are designed the way they are and how they're intended to be used.

8:55 am

RBQM Leads—Orchestrating Methodology Adoption & Change Management

Danilo Branco, Associate Director, Risk Based Quality Management Lead, BeOne Medicines

Creating the cross-functional engagement required for successful RBQM adoption at study level is a known bottleneck in the process. Build rapport with study teams while adding value is critical to achieve it...and requires a specific skillset. In this presentation, let's explore the importance of the RBQM lead role in the QbD approach, meaningful risk control, and, ultimately, nutrition of a risk-based organizational culture.

9:15 am

Integrated Quality and Risk Management Approach—Driving Proportionality into Processes

Bo Maach-Moller, Vice President, Risk Based Quality Management and Central Monitoring, Novo Nordisk AS

How a business case for scaling up fosters interpretation and strategic implementation of GCP E6 R3 principles to redesign processes and business systems as an integrated quality and risk management approach.

9:35 am

Characterizing the Transition from Legacy, Onsite Monitoring to Centralized and Risk-Based Approaches

Hana Do, Research Analyst, Tufts Center for the Study of Drug Development (CSDD)

This session presents the results of a new Tufts CSDD study looking at how companies have made, or are making, the transition from traditional, high frequency on-site monitoring to centralized, remote and risk-based approaches. Qualitative and quantitative data will be reviewed showing how organizations are modifying their monitoring approaches and practices, and the impact of centralized approaches on CRA-site relationship quality and effectiveness.

9:50 am

From Black Box to Glass House: Observations and Lessons from the FDA’s CRL Transparency on Investigators, Sites, and Sponsors

Michael Keens, CEO, Sabai Global

Michael Torok, VP & Global Head, Quality Assurance Programs, Roche Diagnostics

This session examines newly released FDA Complete Response Letter data to uncover quality and operational compliance issues involving sites, investigators, and vendors. By analyzing emerging trends and common contributors to CRLs, the presentation offers practical strategies to reduce compliance risk, strengthen oversight, and improve safety, data integrity, and regulatory submissions across clinical 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

Johann Proeve, CSO, Cyntegrity Germany GmbH

11:15 am

Intelligent Technology: Fueling Human Compulsion for Quality

Clare Campbell-Cooper, Global Head, Digital Health and Innovation, Fortrea

Data quality and integrity remain non-negotiable in clinical research. While innovative technologies are advancing to enhance compliance and quality, our industry continues to rely heavily on people. The adoption of new processes and workflows often faces delays due to slow uptake. This session explores how the convergence of technology and behavioral science can drive the creation of workflows that are resilient, efficient, and future-ready. Learning objectives include discussing the challenges facing adoption of innovation by interested parties and how this is changing over time, understand fundamental concepts unpinning compliance human nature, and seeing examples of where technology insights promote quality and the desire to improve.

11:40 am

Applying Acceptable Ranges: QTLs for Early-Phase and Safety/Exposure-Focused Clinical Trials

Kristin Stallcup, MS, Director, RBQM Operations, Takeda

The ICH E6(R3) concept of “acceptable ranges” broadens the use of Quality Tolerance Limits (QTLs), including for early-phase studies and those with safety/exposure endpoints. But applying QTLs in these settings requires a different approach. This session shares practical tips and considerations for implementing QTLs in safety/exposure-focused, early-phase studies—and why building a consistent framework across all trials can benefit the broader portfolio.

12:05 pm

New Approaches for Risk-Based Data Management and Central Monitoring in Oncology

Jacqueline Cousart, Central Monitoring Manager, Data Management Central Monitoring, Johnson & Johnson

This presentation will focus on how risk-based data management methodology has been introduced with consistency across several trials within an oncology program. Key topics of discussion will include how study teams identified critical data for endpoints early in protocol discussions, the importance of cross-functional collaboration (Central Monitoring, Data Management, Stats, Clinical, etc.), and improvements to monitoring strategies to increase efficiencies.

12:30 pm

RBQM Insights on Asset-Level Integration

Cilla Mistry, Associate Director, RbQM & Central Monitoring, GSK

As Risk-Based Quality Management (RBQM) matures, organizations are expanding its impact beyond individual studies. This session explores how RBQM principles can be strategically integrated at the asset level to drive portfolio-wide insights, optimize oversight, and align with broader business objectives. Learn how to leverage cross-study data, enhance decision-making, and elevate quality management from a study-centric function to an enterprise-wide value driver.

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: Central Monitoring and Signal Detection

8:30 am

Chairperson's Remarks

Leslie Sam, President, Leslie Sam & Associates LLC

8:35 am PANEL DISCUSSION:

Swipe Right for Quality: Good Idea or Nope?

PANEL MODERATOR:

Leslie Sam, President, Leslie Sam & Associates LLC

In this fast-paced, interactive panel session, the audience will vote on whether trending trial management and technology strategies are brilliant or broken. Through a series of “swipe right or nope” prompts—like “Replace end-of-study closeout visits with digital site self-audit tools,” “Enable dynamic ICF updates via SMS,” or “Provide sites with real-time alerts when their data deviates from regional norms”—we’ll explore what resonates with experienced research and quality professionals. Panelists will weigh in after each vote to unpack the hidden pros, real risks, and unexpected impacts. You’ll leave with a sharper sense of how to evaluate innovation for feasibility, compliance, and quality outcomes.

PANELISTS:

Anne Marie L. Inglis, PhD, Senior Director & Asset Lead, Clinical Operations, GSK

Michael Torok, PhD, Vice President, Global Head, Quality Assurance Programs, Roche

9:00 am

Data on the Move: The Secrets beyond the Central Monitoring Signal

Jenn Krohn, MS, Director, RBQM, Clinical Operations, Gilead Sciences. Inc.

Gosia Szczodrak, Director, Clinical Operations, Gilead

This talk explores how the effectiveness of central monitoring in clinical trials is critically dependent on what happens after an alert is raised. The talk emphasizes that the true value of data lies not just in the initial signal, but in the subsequent execution, communication, and clarity of the actions taken. It highlights best practices for ensuring high-quality, clear interactions with study sites, stressing that the precise communication and clear execution of follow-up actions are paramount to mitigating risk effectively and ensuring data integrity. The presentation will reveal how optimizing these post-signal processes is essential for translating central monitoring insights into meaningful, real-world site improvements and overall study success.

9:25 am PANEL DISCUSSION:

Maximizing Efficiency: The Delicate Dance between Central Monitoring and Onsite Activities

PANEL MODERATOR:

Randall Holzberger, MS, Director of RBQM Risk Management, Daiichi Sankyo

Regulatory guidance informs us that the Sponsor should determine the appropriate extent and nature of monitoring based on identified risks. According to E6 R3 Section 3.11.4, "Monitoring may include site monitoring (performed onsite and/or remotely) and centralized monitoring, depending on the monitoring strategy and the design of the clinical trial." Many companies struggle with the relationship between Centralized and Onsite Monitoring Activities. How can we as an industry increase our efficiency by balancing Central/Onsite Monitoring Activities while maintaining or increasing the overall quality?

PANELISTS:

Danilo Branco, Associate Director, Risk Based Quality Management Lead, BeOne Medicines

Taryn Haffner, Associate Director Clinical Operations, Genmab AS

Anne Smith, Senior Director, Central Monitoring, Regeneron Pharmaceuticals, Inc.

Gosia Szczodrak, Director, Clinical Operations, Gilead

9:50 amPresentation to be Announced

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:

From ALCOA to Action: Achieving Fit-for-Purpose, Risk-Proportionate Clinical Data Under ICH E6(R3)

Deborah A. Guattery, GCP Quality Expert, Chase The Sky For Quality LLC

Nechama Katan, Chief Wizard, Wicked Problem Wizards

ICH E6(R3) states: “Clinical trial processes, measures and approaches should be implemented in a way that is proportionate to the risks to participants and to the importance of the data collected.” That means every element of trial design, oversight, and execution can—and should—be risk-based.

But making that shift is more than checking the ALCOA boxes. It’s about building data systems and processes that are fit-for-purpose, so risk triggers proportional, timely, and effective responses. In this interactive working session, participants will split into three focus areas:

Clinical Clarity – defining what’s critical and why
Technology Enablement – ensuring trustworthy and relevant analytics
Workflow Integration – aligning people, process, and data for smooth execution

Using real-world case scenarios, we’ll explore challenges, identify capability gaps, and design practical solutions for implementing proportionate, risk-based quality management. We’ll end by co-creating a concise takeaway summary of the strategies that can turn ICH E6(R3) from a regulatory requirement into a reliable, reproducible practice for success.

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!