ガイダンスが変更され、臨床試験が近代化するにつれ、企業が研究のデザインと実施における品質とリスクについて考える方法も進化する必要があります。SCOPEによる第11回年次「品質・モニタリング」ストリームでは、臨床業務のリーダー向けに、臨床研究サイクル全体および機能的分野におけるリスクベースのアプローチを統合するためのベストプラクティス、ケーススタディ、詳細な戦略を交換する機会を提供します。このプログラムでは、RBQMテクノロジーを活用して研究計画の目標を達成する方法、ICH E6 R3が研究実施に与える影響、リスクベースのアプローチに対するデータサイエンスの活用、規制遵守に関する重要な見識について探ります。
2月3日 月曜日
6:30 amGolf Check-In & Breakfast Buffet (Sponsorship Opportunities Available)
8:00 amSCOPE's 4th Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)
Connect with your peers and colleagues at SCOPE's 4th Annual Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.
*Limited space available. Separate registration and fee required for golf.
9:00 amRegistration Open
12:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)
PRE-CONFERENCE WORKSHOPS: IN-PERSON ONLY
会議前ワークショップ：対面のみ
12:00 pm- 4:00 pm USER GROUP: Innovation Day with IQVIA Technologies: Hear the vision. See the products. Join the journey.
Clinical trial sponsors are invited to join digital product leaders and industry colleagues for an afternoon of discussions, demos, and networking. This interactive event has been carefully curated to help clinical trial professionals crack key challenges across the clinical trial lifecycle: from participant and site user journeys to data security and workflows. Pharmaceutical executives with various roles in clinical operations, innovation, technology, finance/budgeting, data analytics, strategic sourcing, trial managers, medical directors, or patient and site engagement will enjoy an industry panel, interactive roundtables, live demos with product experts, and more! Pre-registration is requested, and IQVIA reserves the right to decline requests that don’t fall within attendee guidelines above: For more details, please contact us.
1:00 pm- 1:45 pm WORKSHOP: Join and Explore ClinEco, SCOPE's B2B Clinical Trial Community and Marketplace
Join this hands-on session with ClinEco, SCOPE’s B2B clinical trial community and marketplace featuring 850+ companies. ClinEco unites sponsors, CROs, service providers, and sites to streamline partnering, vendor research, innovation, and learning. At SCOPE 2024 we introduced the ClinEco Commons, a collaborative space where you can access, visit, and share valuable content as well as contribute to the wealth of knowledge within the SCOPE and ClinEco Community. This year we launch our 'Ask a ClinEco Luminary' program where members can connect directly, and discreetly, with industry leaders and receive insights on a wide range of clinical trial topics. Join now at: clineco.io/register. Open to all SCOPE attendees.
1:00 pm- 2:30 pm WORKSHOP: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trials
INSTRUCTORS:
Michael J. Cohen, Senior Director, Lead, Environmental Sustainability, PPD/Thermo Fisher Scientific
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Jason Lanier, Environmental Sustainability Focus Area, Director, Janssen Clinical Innovation (JCI)
Diana Steinbuesch, BioX Operations Portfolio Lead (Oncology), Roche
While developing leading and innovative therapies, we must not lose sight of the environmental impacts and greenhouse gas emissions. We can reduce the environmental impact of our studies by prioritizing remote visits and monitoring, by reducing kit wastage, and working together to find ‘greener’ solutions. This workshop will provide a brief overview of research and introductory strategies for reducing emissions as well as a 'Sustainability 101' to help anyone in our industry get started towards developing more environmentally responsible clinical trials. Open to all SCOPE attendees. Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.
1:00 pm- 2:30 pm WORKSHOP: Efficient Importation of Biological Materials into the U.S.
INSTRUCTORS:
Jessica Hammes, Branch Chief, Biological Threat Exclusion, Agriculture Safeguarding and Risk Management, Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
Jennifer Merriman, Senior Manager, Strategic Biospecimen & Vendor Logistics, Consent, Biospecimens, & Imaging, Global Development Operations, Bristol Myers Squibb Co.
(Additional speakers to be announced.)
U.S. Customs and Border Protection and partner government agencies regulate the importation of biological materials into the United States. The efficient importation of these items can be challenging, as Clinical Trial landscape is ever-evolving. The purpose of this workshop is to discuss current challenges, best practices, and possible solutions to navigate this landscape.
2:00 pm- 3:30 pm WORKSHOP: Sponsor and Site Perspectives: Addressing Current Challenges and Exploring Future Opportunities in Clinical Trial Financing
INSTRUCTOR:
Dawn Anderson, Partner, Consulting, Deloitte LLP
Ming Shen, Managing Director, Deloitte Consulting LLP
This workshop will explore sponsor and site perspectives on current challenges and future opportunities in clinical trial financing. It will address complexities in managing trial finance including estimation, budgeting, forecasting, invoicing, payments, reconciliation and others in clinical trial management. The workshop aims to identify innovative solutions to enhance finance management in clinical trials, fostering more accurate projections. Through discussions and interactive sessions, it seeks to provide insights for future opportunities to improve clinical trial finance.
MONDAY AFTERNOON PLENARY SESSION:
月曜日午後のプレナリーセッション：
CONVERGING CLINICAL RESEARCH AND CARE, PATIENT PANEL & PARTICIPANT ENGAGEMENT AWARDS
臨床研究・臨床ケアの融合、患者パネル、参加者エンゲージメント賞
Fast-Forward to 2035: What Success Could Look like in Converging Clinical Research and Care-And How to Get There
Mark McClellan, MD, PhD, Director, Duke-Margolis Institute for Health Policy; Former Commissioner, FDA
On this stage in 2024, we spoke about our mission to converge clinical research and clinical care for the benefit of patients worldwide. We envision a world in which patients participate in research at the point of care as seamlessly as possible. And although we’ve set our vision, and organized the work we are undertaking accordingly, the real fruits of those efforts will not be seen in the short term. We will use this session to talk about where we hope we will be by 2035. What might we reasonably achieve? What does success look like? And what will it take to get there? This session is designed to help us all to raise our gaze beyond the near-term and find inspiration in the future possibilities.
Tips for Getting the Most out of SCOPE
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
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 3-6, 2025, at the Rosen Shingle Creek in Orlando, Florida!
What Do Real Patients Actually Talk About?
Whether at an industry event, a focus group, or another venue, we’ve all heard “real” patients share stories of their conditions, treatment journeys, and lives. But how accurate is what you’ve heard? Are the patients who speak on the podium or in a focus group truly representative of the majority of patients, or do they represent just a small sample? Our panel of patient engagement experts from some of the country’s leading patient advocacy groups and other representative organizations will give the story of what it’s like for most patients to live with illness, including rare and chronic diseases. Join us and learn about the true challenges of disease burden, unmet needs, treatment progression, the challenges-and rewards-of clinical trials, and more.
5:05 pmSCOPE's 9th Annual Participant Engagement Awards Introduction (Sponsorship Opportunity Available)
SCOPE's 9th Annual Participant Engagement Awards
Kelly McKee, Head of Innovative Patient Recruitment, Evinova; Co-Creator of the SCOPE Participant Engagement Award
Now in its 9th 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 2025 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
5:45 pmSCOPE's Kickoff Reception: A Luau to Remember!
Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! This year, we're turning up the tropical vibes with a luau theme.
DRESS CODE: Hawaiian shirts are encouraged! Show off your brightest, boldest, most tropical attire (grass skirts optional!) Let's bring the aloha spirit to life as we kick off another amazing SCOPE conference experience. Join us to reconnect with your old friends, make some new ones, and soak up the Florida sunshine in style!
7:00 pmClose of Day
2月4日 火曜日
6:30 amSCOPE's 5K Rise and Shine Fun Run! (Sponsorship Opportunities Available)
Join SCOPE’s Coordinators on Tuesday, February 4 for our 5K Rise and Shine Fun Run! Don’t forget to pack your sneakers.
All of us at Cambridge Healthtech Institute recognize the importance of integrating well-being and fitness into our work travel routines. We're excited to offer our support to faculty, sponsors, and attendees in fostering a culture of wellness. This is an easygoing, informal running (or walking) event. No time chips, running bibs, or energy bars-just a laid-back opportunity for a small group to start the day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk-the goal is to get up and get moving! Meet us in the Rosen Hotel’s front lobby near the birdcage at 6:30 am sharp!
RUN COORDINATORS:
Eileen Murphy, Conference Producer, Production, Cambridge Healthtech Institute
Steve Wimmer, Vice President of Partnerships, 1nHealth
7:30 amRegistration Open
7:30 amMorning Coffee (Sponsorship Opportunities Available)
Get Up and Go! Jumpstart your morning with a specialty made-to-order coffee and some delicious treats, courtesy of our sponsors.
-jpg_35ced57f-4e01-4468-86ac-250cb4049821.jpg)
TUESDAY MORNING PLENARY SESSION:
火曜日午前のプレナリーセッション：
REDUCING CYCLE TIMES WITH “IN-HOUSE” CAPABILITIES, DATING GAME WITH PATIENTS & NEW PARADIGM OF PATIENT-LED TRIAL SPONSORS
「インハウス」機能によるサイクルタイムの短縮、患者とのデートゲーム、患者主導の治験依頼者における新たなパラダイム
*Must be present to win.
Exquisite Clinical Trial Delivery in an Ever-Changing World-Evolution and Opportunity for Sustained Performance
Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.
This talk focuses broadly on Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. More specifically, how has Merck decided to optimize clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams? What are key considerations for clinical trial planning, site selection, and protocol design? And, what and why did Merck keep many core capabilities “in-house”?
Beyond the Real-World Data, What Are Patients Saying?
Special LIVE Episode with Studio Audience-Patient Contestants will be Announced Onsite!
SCOPE’s Gameshow Host: Brett Kleger, a man whose dream it was to be a wedding singer or gameshow host
In today’s episode of “The Clinical Trial Dating Game” we have our pharma industry bachelor looking for a volunteer for his trial. He must question and choose from among three patients, who are hidden from view. He has access to all of their data, but there is more to this person than data, so how will he know which questions to ask? How will he avoid bias? How will he recruit on time? Knowing how important patient centricity is to the clinical research industry and with so much on the line, will our bachelor land a date? What could go wrong?
How Patients Can-and Must-Disrupt Traditional Pharma Clinical Trials
Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Should biopharma companies be the only "sponsors" for clinical trials of new medicines? Does the current model limit opportunities for unmet needs in small populations or leveraging repurposed drugs? This panel will gather leaders demonstrating ways that patient-led non-profit organizations are challenging assumptions and taking a leadership position in medicine development. No longer can we think of patients as guests at pharma's table-is the next transformation in medicine development going to be entirely patient-led?
9:50 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall-Best of Show Voting Opens
Join us for the Grand Opening Networking Coffee break in our biggest SCOPE Exhibit Hall ever! Mingle with friends, forge new connections, and exchange ideas over your morning cup of joe. Visit exhibitors and learn about their latest and greatest innovations and products...voting opens for our Best of Show awards so don’t forget to vote.
Part 1: Risk-Based Quality Management
パート1：リスクベース品質管理
FUNDAMENTAL PIECES OF THE RBQM PUZZLE
RBQMパズルの基本ピース
11:00 amChairperson's Remarks (Sponsorship Opportunity Available)
RBQM Revealed: A Decade of Discovery & the Blueprint for Tomorrow’s Breakthroughs
Joanne Benedict, Senior Director, Clinical Operations, Head, Risk Based Quality Management, Gilead
Risk-based quality management (RBQM) of clinical trials has evolved over the past decade. This talk will explore the lessons learned and innovations that have shaped more effective trial monitoring and risk mitigation. This presentation will also outline forward-thinking initiatives at Gilead in reducing inefficiencies in monitoring and the application of RBQM.
In Pursuit of Adoption: Risk-Based Quality Management and ICH E6 R3
Nicole Stansbury, Senior Vice President, Global Clinical Operations, Premier Research; Co-Lead, Risk-Based Monitoring Working Group, Association of Clinical Research Organizations (ACRO)
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) renovation of Good Clinical Practice (GCP) represents a philosophical shift in the conduct of clinical research away from a one-size-fits-all approach to a more pro-active, risk based approach. RBQM is the bedrock of drug development excellence: our goal is to enhance understanding and increase implementation of key topics detailed in ICH E6 R3. After soliciting direct feedback from our respective member companies, ACRO and TransCelerate have developed a set of tools to support the implementation of a strong foundation for quality in clinical development.
Critical-to-Quality Factors (CTQs)-Beginning with the End in Mind
Cilla Mistry, Central Monitoring Process Manager, Central Monitoring and Data Analytics, GSK
This talk will provide an overview of RbQM, how to implement CTQs, when CTQs should be identified, and dealing with mindset shifts from the study team when implementing RbQM. Increasing awareness of CTQs will help deliver and conduct our trials with a RbQM mindset. Quality of data, patient safety, and reliable data are key as per our ICH GCP guidelines.
Right From the Start? Story on How Risks Identified at the Study Design Phase Foster Cross-Functional Early Engagement and Pay Off During the Study Conduct Phase
Maha Raheb, MD, Associate Director, Risk-Based Quality Management, AstraZeneca
This presentation will focus on a new strategy for fostering cross-functional early engagement during the design phase, aimed at developing quality risk management strategy. Enhancements to quality will be achieved by prioritizing critical data and de-prioritizing efforts on non-critical data
Patient Voice as the Next Frontier in Trial QualityLaura Engerman, Principal, R&D, ZS Associates
Incorporating patient voice into clinical trial design and planning is crucial for identifying and mitigating quality risks. Diverse patient voice enhances trial quality and safety by ensuring study objectives are meaningful and scientifically valid, but it can be difficult to apply at scale. At ZS, we've developed the Patient Experience Bank, a scalable solution enabling the integration of 5 million+ data points of diverse patient insights into development decisions. This capability can prevent risks derived from misunderstandings and operational challenges, aligning with regulations such as ICH guideline E8 (R1) to identify critical-to-quality factors at the risk assessment. Join ZS leaders Laura Engerman and Jonathan Rowe as they explore the transformative power of integrating patient voice into clinical.
Talk Title to be Announced1:35 pmSponsored Networking Luncheon
Take this opportunity to refresh and refuel and network, compliments of SCOPE sponsors! Take a well-deserved break outdoors in the sun, or indoors in the air conditioning.
2:35 pmNetworking Coffee & Dessert Break in the Exhibit Hall
SCOPE’s hall this year is bigger than ever; there’s no way to cover it all in just one break. So, after lunch, grab some dessert and a cup of coffee and visit all those booths that you just couldn’t make it to this morning. Stay to hear our Best of Show Winner announcement and congratulate the winner!
THE ROLE OF CLINICAL DATA IN STUDY QUALITY
研究品質における臨床データの役割
3:20 pmChairperson's Remarks (Sponsorship Opportunity Available)
Integrating Data Science at-Scale: Lessons Learned in RBQM and Anomaly Detection for Clinical Operations
Alicia Worrall, Associate Director, Centralized Monitoring and TA Analytics, Data & Statistical Sciences, AbbVie, Inc.
As the volume of clinical studies continues to grow, ensuring efficient resource allocation and robust risk detection is crucial. AbbVie’s in-house Risk-Based Quality Management (RBQM) platform not only brings advanced anomaly-detection capabilities but also represents a significant change management initiative. This talk will explore how our technology streamlines risk detection and management, leading to increased operational efficiencies. We will discuss the dual challenge of implementing a complex technological solution alongside managing organizational change. Key topics include implementation challenges, crucial lessons learned, derived benefits, and future use cases, showcasing how RBQM integrates seamlessly into our operational fabric.
3:55 pmSponsored Presentation (Opportunity Available)
Using Audit Trail Data to Ensure Fit-for-Purpose Data for Clinical Trials
Elevating Quality Management through Analytics
Kevin Richards, Head, Quality Investigations & Analytics, AstraZeneca
There is a clear conceptual link between Quality Management and Analytics, encapsulated in the maxim, “You can’t manage what you can’t measure.” In practice, however, many pharmaceutical organizations struggle to operationalize this idea: quantifying quality is filled with challenges, both technical and organizational. Through detailed case studies, it will be illustrated how quality analytics can drive meaningful impact, providing a roadmap to true proactive quality in your organization.
Analytics for Automated Outlier Detection of ePRO Data: Ensuring Data Integrity and Quality in Clinical Trials
John Samuelsson, PhD, Senior Data Scientist, Artificial Intelligence & Machine Learning Quantitative & Digital Sciences, Pfizer Inc.
Here we present a method for automated detection of low-integrity ePRO data at the site level. This approach is data-driven and multivariate, acting as a complement to the heuristic and univariate analyses currently done by central monitors in CluePoints. The algorithm converts the ePRO data into numerical format, computes site-level features and detects outlier sites using an ensemble of Empirical-Cumulative-distribution-based Outlier Detection (ECOD) and Density-Based Spatial Clustering of Applications with Noise (DBSCAN).
Advancements and Challenges in Clinical Trial Data Quality Control: A Roadmap for Audit Trail Analysis
Olgica Klindworth, Vice President, Data Quality and Risk Management Solutions, Medidata a Dassault Systemes Co.
Considering increasing complexities in data acquisition, data managers and operational users must enhance their approach to data quality oversight by utilizing a wider array of data sources, including audit trails. The sheer volume of audit trail data can be overwhelming, and users often struggle to identify critical insights or analyze this information despite regulatory guidance. Consequently, the industry must develop more efficient methods for analyzing audit trail data to ensure robust data integrity controls.
5:55 pmWelcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)
Wind down at the end of a busy session day with colleagues and old and new friends. Networking is always in full swing at this reception, so raise a glass with your favorite exhibitors and take a chance at winning one of our fabulous raffle prizes (must be present to win). Continue your networking over dinner at one of the Rosen Shingle Creek's fine dining or casual restaurants and eliminate the need to face Orlando traffic.
7:15 pmClose of Day
7:15 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)
The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.
Shuttles will run a continuous loop from 7:00pm-11:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.
2月5日 水曜日
7:45 amRegistration Open
BREAKFAST PRESENTATIONS
朝食プレゼンテーション
BREAKFAST PRESENTATION OPTION #1:Digital Innovation’s Role in Pediatric and Elderly Clinical Trials
Kyle Hogan, Chief Executive Officer, Datacubed Health
This presentation examines how targeted digital tools improve retention rates among pediatric and elderly participants. Our pediatric focus reveals how gamification can create meaningful connections and enhance the trial experience while engaging caregivers. For elderly participants, we examine the use of accessible interfaces and remote monitoring solutions to address age-specific challenges. Attendees will discover strategies for implementing these solutions within their research programs.
BREAKFAST PRESENTATION OPTION #2:Expanding the Patient Universe: Transforming Clinical Trials through Inclusive, Data-Driven DesignChristopher Riley, Director, Strategic Insights, Solutions, H1
In today’s complex clinical research landscape, achieving patient-centricity and inclusivity is more critical than ever. This presentation introduces Patient Universe, a groundbreaking solution designed to optimize trial feasibility while addressing health equity challenges. Attendees will learn how leveraging real-world health equity data can transform patient recruitment strategies, create inclusive trial designs, and improve participant engagement. Through actionable insights and use cases, this session will demonstrate how advanced analytics and innovative technologies can bridge gaps in representation, support diversity action planning and enhance trial outcomes.
BREAKFAST PRESENTATION OPTION #3:Scaling Success: How Sanofi and Trialbee Drive Patient-centric Recruitment and Reduce Site Burden in Global Asthma Programs
Join Whitley Albright (Sanofi) and Gaynor Anders (Trialbee) to discuss how to keep patients at the center of focus while reducing site burden in a complex global asthma program by: connecting patients to the right trials with targeted outreach and a highly efficient global process; pre-qualifying all patients with live medical secondary screening to reduce the volume sent to sites, improve trust, and increase referral-to-consent ratio; keeping disqualified patients ready to enroll with program-level rematching; centralizing activity in a Patient Recruitment Platform (PRP) to manage progress, evaluate site performance, and measure campaign ROI; building a collaborative, supportive, and meaningful relationship.
Learn how these organizations are scaling recruitment success globally while achieving diversity and inclusion goals, reducing site burden, and keeping patients at the center of care.
8:45 amTransition to Sessions
MONITORING QUALITY THROUGHOUT STUDY CONDUCT
研究計画に品質を組み込む
8:50 amChairperson's Remarks (Sponsorship Opportunity Available)
Integrating Meaningful Diversity Metrics into Clinical Monitoring
Martha Dockery, MS, Associate Director, Clinical Monitoring, Health Equity Champion Exact Sciences
By identifying essential demographic and site-specific characteristics, monitoring teams can transform diversity data into actionable performance indicators. These metrics guide quality measures, ensuring continuous improvement in oversight activities. Incorporating diversity metrics into monitoring plans and risk assessments fosters more equitable and representative clinical trial environments.
Leveraging RBQM Technologies to Achieve Diversity Action Plan Goals
This talk will build upon previous work in leveraging RBQM technologies and central monitoring strategies to develop, execute, and oversee Diversity & Inclusion in clinical trials. A case study will be presented on leveraging RBQM technology for implementing Diversity Action Plan goals.
Debate: Fraud and Misconduct in Clinical Trials: Marginal Nuisance or Major Problem?
Lukasz Bojarski, Executive Director, Centralized Monitoring & Risk Based Quality Management, AstraZeneca
Misconduct cases in clinical trials world get significant attention. Are the discovered and publicized situations a tip of an iceberg or isolated incidents? During the session, two experienced RBQM leaders: Marcin Makowski, GSK and Lukasz Bojarski, AZ will clash in a debate on the topic of scale and importance of fraud and misconduct.
Beyond the Benchmarks: Setting New Standards for Speed in Clinical Trials
We’ll demonstrate how to accelerate drug development by enhancing study speed, quality, and outcomes through a centralized platform that consolidates all data sources. This advanced technology integrates seamlessly into existing workflows, leveraging machine learning algorithms to filter noise, enable real-time monitoring, and optimize workflows. These advancements, radically reduce manual data transfers and errors, ensuring data consistency and boosting data flow and communication.
10:25 amCoffee Break in the Exhibit Hall
SCOPE is ALL about networking-with clients, colleagues, sponsors and exhibitors. Take this chance to visit booths you haven't been to, build new relationships, and fuel up with coffee for the rest of the busy day ahead. Last chance to vote for the Best of Show award! Make your vote count!
10:45 amSpecial Book Signing
Fundamentals of Decentralized Clinical Trials
Editors: Isaac R. Rodriguez-Chavez & Anna Yang
Location: Gatlin Foyer, ClinEco Booth #4
Part 2: Central and Remote Monitoring
パート2：中央/リモートモニタリング
BEST PRACTICES FOR STUDY RISK ASSESSMENT
研究リスク評価のベストプラクティス
11:20 amChairperson's Remarks (Sponsorship Opportunity Available)
Best Practices for Study Risk Assessment
Discover the future of clinical trial risk assessments with a presentation from PHUSE’s Risk Assessment Working Group co-chairs. Comprised of volunteers from across the industry, the Phuse working group is tackling the challenge of time-intensive risk assessments by refining processes and emphasizing Critical to Quality (CtQ) risks. Through the establishment of innovative best practices and delivery of a risk assessment white paper, the Phuse working group seeks to provide a framework organizations can leverage to enhance their risk assessment process . Don’t miss this presentation highlighting their progress and collaborative efforts to solve this industry challenge.
Your Roadmap to RBQM Rollout: Applying Change Management for Lasting Impact
This session will explore how a well-designed change management roadmap, anchored in the 4 R’s-Right Information, Right People, Right Way, Right Time-can effectively eliminate barriers that often hinder RBQM initiatives. A real-world case study will be presented to demonstrate how these principles were applied to overcome obstacles, ensuring a smooth, efficient, and impactful RBQM rollout that drives lasting success across studies and projects.
360° Monitoring: A New Approach to Dynamic Clinical Oversight Using Centralized Insights
Olgica Klindworth, Vice President, Data Quality & Risk Management Solutions, Medidata, a Dassault Systemes Co.
Manual data interrogation. Overlooked risks. Inefficient monitoring. It’s time to transform the outdated paradigm of clinical oversight with centralized, automated data insights that improve performance end-to-end, from guiding site selection decisions to fueling dynamic monitoring strategies. Anchored in a risk-based framework, this approach bridges protocol objectives with operational execution to maximize quality and efficiency. Join this session to learn how integrated solutions are redefining trial oversight and quality management for today’s complex clinical landscape.
12:55 pmSponsored Networking Luncheon
Once again, join us for lunch, courtesy of our generous sponsors.
1:55 pmNetworking Coffee & Dessert Break in the Exhibit Hall-Best of Show Winner Announced
SCOPE's Networking Coffee and Dessert Break is the perfect time to pick up a sweet treat, courtesy of our sponsors, and fuel up for the afternoon with a cup of coffee or soft drink. Visit our Game Card Sponsors to fill your Game Card with stickers and get in a little more networking time before afternoon sessions!
-jpg_3fef6f50-a8ff-4613-b844-9dd3fd020160.jpg)
WEDNESDAY AFTERNOON PLENARY SESSION:
水曜日午後のプレナリーセッション：
FOSTERING INNOVATION IN PHARMA R&D, LEVERAGING DIGITAL TOOLS WITHOUT LOSING YOUR MIND & UNLEASHING GenAI FOR TRIALS
製薬R&Dにおけるイノベーションの促進、デジタルツールの活用、試験向けGenAIの活用
Fostering Clinical Innovation in a Large Pharmaceutical Organization
April Lewis, Head, Innovative Health, Global Development, Johnson & Johnson Innovative Medicine
This presentation explores strategies for fostering innovation within a large pharmaceutical organization by focusing on four key areas: developing a clear mandate and compelling vision to guide innovation efforts; designing and engineering an infrastructure that supports creativity and collaboration; building a high-performance, diverse team empowered to drive innovation; and seeking opportunities for true patient-centricity and sponsor-agnostic innovation. By aligning these elements, the organization can create a sustainable innovation ecosystem that prioritizes patient outcomes and drives transformative breakthroughs in healthcare.
How Can Sponsors Leverage Increasing Technology Capabilities with Quality
Angela DeLuca, Associate Vice President, Global Study Operations, Amgen
Sponsors can leverage increasing technology capabilities to enhance quality by integrating advanced data analytics, AI, and automation into their drug development and manufacturing processes. These technologies enable real-time monitoring, predictive analytics, and streamlined workflows, ensuring higher precision and consistency in product quality. Additionally, digital tools facilitate better compliance with regulatory standards and more efficient management of clinical trials, ultimately accelerating time-to-market while maintaining rigorous quality standards.
3:25 pmChairperson's Introduction (Sponsorship Opportunity Available)
The Unleashing of Gen AI: Revolutionizing Healthcare and Beyond
Disa Lee Choun, Head of Integrated Clinical and Operational Analytics (ICOA), Johnson & Johnson
Gen AI, a groundbreaking approach that seamlessly merges artificial intelligence into our daily lives, holds immense potential for transforming the pharmaceutical and healthcare industries. This paradigm shift not only demands a thorough understanding of the ethical implications, potential biases, and social consequences of AI systems- it also requires a steadfast focus on creating tangible value that benefits individuals and society at-large. By harnessing advanced AI technologies, Gen AI can pave the way for unparalleled breakthroughs, elevating patient care, enabling personalized medicine, streamlining processes, and revolutionizing the way we approach healthcare as a whole. Join the debate on the real value-based use cases and explore the endless possibilities that Gen AI brings to the table.
4:00 pmBooth Crawl & Refreshment Break in the Exhibit Hall (Sponsorships Available) Last Chance for Exhibit Viewing
We know you're tired, we know the Exhibit Hall is huge, and we know you still have some booths to visit, some connections to make, some networking to do. SCOPE's Networking Booth Crawl is the time to do it! Crawl if you must, but be sure to visit our sponsored booths for some food, drinks, and enough energy to finish SCOPE strong! Our final Networking Exhibit Hall break is the final time to see the exhibits you haven't seen and meet the people you haven't yet met. The break ends with another amazing raffle prize, so be sure to get your Game Cards in and the lucky winner (must be present to win) could be you!
5:00 pmClose of Day
5:00 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)
The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.
Shuttles will run a continuous loop from 5:00pm-9:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.
2月6日 木曜日
7:15 amRegistration Open
BREAKFAST PRESENTATION
朝食プレゼンテーション
BREAKFAST PRESENTATION:What sites really need to deliver successful patient engagement strategies
Sites have shared that delivering successful patient recruitment is arguably one of the most persistent challenges they face. Despite this being well-known, not enough of the right support is provided to them, causing more than half of sites to pay out of pocket for unreimbursed recruitment expenses, all while the one-size-fits-all recruitment materials provided to them collect dust. By rethinking how we support sites in their patient engagement activities, sponsors and CROs can shift the paradigm to make patient enrollment delays and declining retention rates outliers, instead of the norm. This breakfast session will discuss strategies to transform patient engagement by leveraging site experience, incorporating patient insights and motivations, as well as AI solutions, to improve patient retention and deliver better study outcomes.
8:15 amTransition to Sessions
MAXIMIZING THE VALUE OF CENTRAL MONITORING
中央モニタリングの価値を最大化
8:20 amChairperson's Remarks (Sponsorship Opportunity Available)
Protecting Data Quality: Implementing and Demonstrating the Value of Centralized Monitoring
Jennifer Krohn, MS, Associate Director, RBQM, Clinical Operations, Gilead Sciences. Inc.
Centralized monitoring (CM) is widely accepted as an integral component of robust clinical-trial monitoring strategy due to its ability to identify data-quality risk that traditional monitoring does not have the vantage point to detect. However, there are challenges in implementing and demonstrating its value. This talk will review PHUSE's investigation into these topics and seeks to inspire additional industry collaboration in further developing open-source CM capabilities.
A Unique Transition from Outsourced Centralized Monitoring to an in-House Process in a Very Short Timeframe
Anne Smith, Director, Central Monitoring, Regeneron Pharmaceuticals, Inc.
This talk will highlight our team's transition from outsourced centralized monitoring to an in-house model within a shortened timeframe. We used a unique approach, working with internal and external stakeholders to implement the new model. This presentation will go through the challenges and lessons learned, and provide a blueprint upon which to model similar efforts.
How RBQM Builds Trust between Sponsors and CROs
Duncan Hall, CEO, Executive, Triumph Research Intelligence Ltd.
Duncan explores the big communication and trust challenges we see from hundreds of projects, and presents a simple model based on Risk-Based Quality Management to overcome those trust issues. He looks at what the ultimate customers (regulatory authorities) want to see, including the implications of ICH E6(R3). He also shows how having the right technology makes all the difference.
Accelerating Clinical Success: Egnyte's Unified Platform for Data Governance and Secure Collaboration
Catherine Hall, Head of GXP Quality Assurance, Sales, Egnyte, Inc.
Life sciences organizations face intricate data handling challenges and compliance requirements in today's clinical trial environment. With evolving regulatory frameworks like ICH E6 (R3) emphasizing more robust data governance, these challenges continue to grow. This session showcases how Egnyte's cutting-edge platform addresses these complexities by employing seamless data governance over diverse data and content in a secure collaborative platform
The Many Faces of Clinical Data Integrity
Lukasz Bojarski, Executive Director, Centralized Monitoring & Risk Based Quality Management, AstraZeneca
The ICH E6 (R3) draft requires data monitoring to extend across multiple data integrity aspects which span from patient eligibility to unexpected lack of variability and potential data manipulations. From a centralized monitoring perspective, such a broad scope requires not only a variety of data analysis techniques, but also different approaches to handling insights generated from the data. In this session, I am going to discuss how a “one size does not fit all” principle applies to signal detection methods and findings management.
Challenges and Strategies for Managing Central Monitoring Action Fatigue
Olivia Feiro, Director, Clinical Risk and Document Management, CSL Behring
Not every risk can be mitigated with a direct action and confirmed as resolved in the subsequent review cycle. What happens to the dynamics between the RBQM and study team when risks persist over a long period of time or when RBQM is performed on a long-term study? This panel will explore the challenges of such risks and strategies for collaboration and communication across teams.
11:10 amNetworking Coffee Break
ADVANCING DIGITAL HEALTH AND CLINICAL TRIALS CONVERGENCE
デジタルヘルスと臨床試験の融合を推進
Applying Social Determinants of Health (SDoH) in Clinical Planning and Site Strategy
Daoying Hu, PhD, MBA, Director, Data Science and Digital Health, Johnson & Johnson Innovative Medicine
SDoH data can enhance our understanding of the barriers to participation in clinical trials and improve access for study participants. This presentation examines various types of SDoH data for site and patient strategies, and discusses how to effectively leverage these insights in clinical studies.
Achieving Flexibility and Expanding Access While Preserving Data Quality
Lindsay Kehoe, Project Manager, Clinical Trials Transformation Initiative
Is trial flexibility truly a threat to data quality? Concerns are often raised that offering flexible approaches to clinical trial design and conduct, such as collecting data in various settings and offering a flexible schedule of visits, will result in risks to data quality. This session will explore multi-partner perceptions around when and how data quality is maintained when flexible approaches are introduced and how flexibility can improve access to clinical trials.
1:25 pmTransition to Lunch
LUNCHEON PRESENTATION: From Sync to Swim: Alimentiv’s Journey with Zelta ePRO
Amid growing responsibilities and expanding clinical operations, data managers are increasingly challenged by the increasing number of eClinical solutions required to support a clinical trial. Join us to learn how the data managers at Alimentiv have leveraged Zelta’s ePRO module to streamline their eClinical data collection scheme to include patient-reported outcomes with the rest of their study data, achieving more control over their clinical trials and confidence in their outcomes.
2:00 pmSCOPE Summit 2025 Adjourns
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
アジェンダ・講演者・スポンサー更新
2025年 プログラム
◆
Sunday Golf, Kick-Off Keynote & Participant Engagement Award
月曜のゴルフ、キックオフ基調講演、参加者エンゲージメント賞
◆SCOPE’s Kickoff Reception
SCOPEによるキックオフレセプション
◆
Patient Voice in Trial Design and Protocol Development
試験デザインとプロトコル開発における患者の声
◆
Developing and Executing Effective Diversity Plans
効果的な多様性計画の策定と実行
◆
Enrollment Planning and Patient Recruitment
登録計画・被験者募集
◆
Patient Engagement and Retention through Communities and Technology
コミュニティ・技術による被験者エンゲージメントとリテンション
◆
Clinical Trial Forecasting, Budgeting and Contracting
臨床試験の予測・予算編成・契約
◆
Resource Management and Capacity Planning for Clinical Trials
臨床試験のリソース管理・キャパシティプランニング
◆
Mastering an Outsourcing Strategy
アウトソーシング戦略のマスター
◆
Relationship and Alliance Management in Outsourced Clinical Trials
臨床試験アウトソーシングにおける関係と提携管理
◆
Modernizing Lab, Biomarker & Data Management Operations
ラボ・バイオマーカー・データ管理業務の近代化
◆
Biomarker & Biospecimen Technology & Innovation
バイオマーカー・バイオ試料の技術とイノベーション
◆
Data Technology for End-to-End Clinical Supply Management
E2Eの臨床サプライ管理向けデータ技術
◆
Clinical Supply Chain Strategies to Align Process, Products and Patients
臨床サプライチェーン戦略でプロセス・製品・被験者を連携
◆
Clinical Trial Venture, Innovation & Partnering *
臨床試験のベンチャー・イノベーション・提携 *
*Separate Registration Required
