Feasibility and Study Activation

2024 ARCHIVES

Identifying the most appropriate sites and effectively partnering to streamline site activation, start-up, and operations is a daunting task. The convergence of the pandemic, regulation changes, patient- and site-centricity, DEI, real-world data, new analytics capabilities, digital and decentralized site and patient partnership models are challenging traditional feasibility methodologies. SCOPE’s Feasibility and Study Activation track will explore new approaches to overcome these challenges.

Monday, 28 October

14:30– 19:00 Innovation Day with IQVIA Technologies at SCOPE Europe

CO-SPEAKERS:

Garth Dabbs, Vice President, Product Strategy, DPS, IQVIA

Stefan Dürr, Senior Director, Client Delivery, IQVIA Technologies

Petar Genov, Senior Director, Business Operations and Capabilities – Payments, IQVIA Technologies

Raphaelle Gilg, SSO Strategy & Operations Manager, Novartis

Bernhard Glombitza, Vice President & Head of Clinical Operations and Customer Engagement EMEA & LATAM, Bayer

Bernd Haas, Senior Vice President, Digital Products & Solutions, IQVIA

Adrian Kizewski, Associate Director, Clinical Technology, IQVIA Technologies

Kevin Landells, Vice President Patient Centered Technology Delivery, IQVIA Technologies

Alison Liddy, Senior Vice President, Patient and Site Centric Solutions, IQVIA

Marisa Minetti, Patient Research Partner, Chiesi Group

Majd Mirza, PhD, Chief Innovation Officer, Viedoc

Chloe Rose, Executive Director, Portfolio Management, Pratia

Clinical trial sponsors are invited to join IQVIA Technologies’ digital product leaders and clinical trial sponsor executives for an afternoon of discussions, demos, and networking. IQVIA will share our vision to transform clinical operations, demonstrate our technologies that improve the patient, site, and sponsor journeys, and ask for your input on our roadmap for future product development. A highlight of the agenda is the industry panel discussion on the latest research and trends in clinical technology and its impact on productivity. Innovation Day is complimentary and will be of interest to pharmaceutical executives or sites with roles in clinical operations, innovation, technology, finance, budgeting, data analytics, patient or site engagement, or strategic sourcing. IQVIA reserves the right to decline registrations for those not in these categories. For more information or to register click here.

17:30– 19:00 The Path towards Sustainable Clinical Trials: How to Minimise Environmental Impact and Stay Ahead of Future Regulatory Requirements

INSTRUCTORS:
Fiona Adshead, Chair, Sustainable Healthcare Coalition
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Marisa Minetti, Patient Research Partner, Chiesi Group
Keith Moore, Programme Coordinator, Sustainable Healthcare Coalition
Developing frameworks to define and manage sustainability risks, and effective guidelines to reduce the carbon footprint of clinical trial operations is a collaborative effort. Beyond benefiting the environment, adopting sustainable practices is increasingly demanded by stakeholders and can significantly influence customer choices and talent acquisition. Perhaps more compelling are the growing regulatory pressures and expectations, including the Corporate Sustainability Reporting Directive (CSRD) and Task Force on Climate-related Financial Disclosures (TCFD) among others. This workshop will discuss the current hotspots of carbon emissions in clinical research, introduce a new clinical trial carbon footprint calculator for assessing current state, and suggest introductory reduction strategies. Whether you are in clinical trial design clin ops, procurement, innovation, sustainability, or resource management, this workshop is for you.

Tuesday, 29 October

SCOPE Europe Fun Run/Walk Up the Magic Fountain Steps07:00

Join SCOPE Europe’s Coordinators for our Fun Run/Walk! All of us at Cambridge Healthtech Institute recognise the importance of integrating well-being and fitness into our work travel routines. This is an easygoing, informal running (or walking) event where we ascend the stairs of the iconic Magic Fountain. 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 front lobby at the InterContinental at 7 sharp!

Registration and Morning Coffee07:45

Organiser's Welcome Remarks08:50

08:55

Chairperson's Remarks

Abhishek Chatterjee, Head, Health Data Insights and Design a.i., Novartis

09:00

Feasibility and Site Identification Powered by Data and Gen AI

Carole Ackermann, EEA Cluster Portfolio Head, Novartis

Abhishek Chatterjee, Head, Health Data Insights and Design a.i., Novartis

Tony Yordanov, Clinical Operations Program Director, Novartis

Despite significant advancements in clinical trial processes and technology, the industry continues to face challenges in delivering medicines efficiently, on time, and at a lower cost. An efficient data and AI-driven feasibility approach, combining human insights, process, and technology has the potential to bring the patient into focus. However, the integration of AI into the development process presents its own set of challenges. Let's explore how AI can enhance clinical trial feasibility efforts and consider practical ways to approach the challenges of integrating AI into the development process.

09:25

Embedding Digital Tools and Data-Driven Approaches for Site Selection: Change Management, Training Needs, and Implementation Strategy

Susannah Finney, Clinical Operations Lead, Product Development Global, Roche

Effective site-selection is key for a study's speed and success. Shifting the foundation of this decision from a basis of personal experience to objective data requires strategic rollout and a long-term organisation mindset shift. Roche has embedded Sitescape: an objective data-driven site-selection tool. Join us to learn how we navigated this change in both process and behaviour.

09:50

Unlocking AI-Enriched EHR Data for Precision Psychiatry through the Akrivia Health Research Platform

Benjamin Fell, Head of Research, Research and Development, Akrivia Health

The drive for precision psychiatry has increased the availability of high-dimensionality molecular data, rich real world phenotypic data remains difficult to access. Akrivia Health has addressed this challenge through a 15-year programme creating digital research infrastructure and data enrichment pipelines for NHS psychiatric electronic health records. The result is a research-ready dataset of 5 million+ patients' full EHR histories, enriched through an AI-driven NLP pipeline, providing the scale and depth of information needed to realise precision psychiatry’s promise.

10:15

Bridging the Gap: Integrating Data Science and Gen AI in Feasibility

Nadia Lim, Head, Feasibility Strategy & Analytics, Pfizer Inc.

Joao Goncalo Nascimento, Performance Analyst, Predictive Analytics – PRD (OARS), Pfizer Inc.

In this talk, we share new ways of working in feasibility to optimise clinical trial execution. We address operational challenges in integrating new technologies in feasibility, such as data science and Gen AI. We discuss how we optimise feasibility planning while also considering the risks, alongside user adherence, and the necessity of explainability. These considerations are crucial for the successful application of these innovations to improve site selection.

10:40

Streamlining Study Start-Up: Accelerating Site Activation & Reducing Tech Burden for Sites

Tom Johnson, Senior Director, Life Sciences & Health IT, Exostar

Lestter Cruz Serrano, Head of Medical Affairs & Global Site Engagement, Cognizant SIP

We hear you. Sponsors are challenged with lengthy study start-up processes and ongoing monitoring, while the clinical trial sites are burdened with technology redundancy and sign-on silos obstacles. In this talk, we will give the sponsor's and site's perspective on the progress made to overcome these issues and share real examples of how sponsors and sites are collaborating and streamlining the user’s experience.

Grand Opening Coffee Break in the Exhibit Hall10:53

The SCOPE Europe Exhibit Hall is the best place to fuel up with a mid-morning coffee while visiting with our many exhibitors. Learn about what’s new in the industry, connect with colleagues and vendors, and make some new friends.

11:50

Chairperson's Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

11:55 KEYNOTE PRESENTATION:

Reinventing Clinical Development and Overcoming Unnecessary Complexity

Bernhard Glombitza, Head, Clinical Operations EMEA and LATAM, Bayer

This keynote presentation proposes a paradigm shift in clinical development, advocating for the adoption of a minimal viable product (MVP) approach focused solely on fulfilling regulatory requirements. By streamlining processes and resources to the essentials, this strategy promises significant cost reductions and time efficiencies while maintaining regulatory compliance. Through case studies and implementation strategies, attendees will gain insights into how embracing this innovative approach can revolutionise clinical development, paving the way for greater agility, adaptability, and patient-centricity in the industry.

12:20 KEYNOTE PRESENTATION:

ClinEco Commons and the Power of the Clinical Research Community

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

The Commons is a ClinEco and SCOPE resource. It is a go-to hub for resources, tools, news, regulatory updates, and more, designed to support professionals in the field of clinical research. The Commons serves as a collaborative space where you can access, visit, share valuable content as well as contribute to the wealth of knowledge within the SCOPE and ClinEco community. The "Ask a ClinEco Luminary" feature allows users to connect directly with research leaders to learn from colleagues.

12:30 KEYNOTE PANEL DISCUSSION:

Converging Clinical Research with Clinical Care: A Multi-Stakeholder Panel on Tackling This Bold Vision

PANEL MODERATOR:

Paul Duffy, Head, Global Clinical Site Partnerships, MSD

This plenary panel will show how stakeholders across biopharma R&D have come together to develop pragmatic solutions that are foundational to enabling the future of drug development and integrating clinical research as part of the care continuum. This panel will feature biopharma industry leaders, Health Authorities, patient advocates, and other industry consortia candidly discussing why everyone must work together to drive innovation in the R&D ecosystem, shape the future of healthcare, and bridge the gap between clinical research and clinical care.

PANELISTS:

Maria Dutarte, Executive Director, European Patients’ Academy on Therapeutic Innovation (EUPATI)

Maria Koutsopoulou, Senior Vice President, Head of Global Development Operations, Merck KGaA

Bari Kowal, Senior Vice President & Head, Development Operations & Portfolio Management, Global Development, Regeneron Pharmaceuticals, Inc.

12:55

SCOPE Europe 2023 Accelerator Project Update and Outcomes: Innovative Outsourcing Process for Biotech

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

Last year at SCOPE Europe we engaged with sponsor orgs in attendance on a project with ClinEco, our B2B clinical research marketplace and network, to help with scoping, selection, and onboarding of outsourcing partners for a trial. The goal was to challenge the norms of clinical trials outsourcing, improve vendor selection, and speed up the RFI process...and more. We learned a lot with our partner and some of those key learnings apply to us all.

13:00 KEYNOTE PANEL DISCUSSION:

Quantifying the Collection of Non-Core and Extraneous Core Protocol Data and its Relationship with Clinical Trial Performance

PANEL MODERATOR:

Emily Botto, Senior Research Analyst, Tufts Center for the Study of Drug Development

This panel discussion provides perspectives and updates on a collaborative research study looking at optimizing non-core and extraneous clinical research data collection practices, with the aim to reduce patient and site burden. The panel will explore considerations that helped define the study methodology and insights expected from the study findings that will inform new protocol design strategies.

PANELISTS:

Paul Duffy, Head, Global Clinical Site Partnerships, MSD

Joachim Lovin, DCT Specialist, Novo Nordisk

13:25Transition to Networking Luncheon in the Exhibit Hall

Join Your Peers for a Networking Lunch in the Exhibit Hall13:35

Take this opportunity to refresh and refuel with our Exhibit Hall lunch. Enjoy good food and even better conversation during our walk and talk luncheon.

14:35

Chairperson's Remarks

Marcy Kravet, Vice President, Strategic Operations, Inato

14:40 PANEL DISCUSSION:

Increasing Trust & Transparency to Accelerate Site Selection and Start-Up

PANEL MODERATOR:

Marcy Kravet, Vice President, Strategic Operations, Inato

A recent global survey revealed a striking disconnect: While 72% of research sites believe that sponsors trust their feasibility data, only 13% of sponsors and CROs actually report trust in these site responses. This disparity highlights a critical trust gap, contributing to significant stress during site selection—92% of sponsors/CROs and 70% of site representatives report experiencing this stress. Our panel discussion will delve into these findings and more from the first-ever global survey on Trust & Transparency in Site Selection. We'll explore how data and technology can be harnessed to streamline feasibility, accelerate timelines, and alleviate burden for both sites and sponsors.

PANELISTS:

Rosia Shah, MD, Medical Lead, VCTC

Thomas Westgate, Director, Strategic Feasibility, Clinical Research, PPD, part of Thermo Fisher Scientific

15:05

Clinical Trial Diversity: Expanding Past the FDA to the Rest of the Globe

Bryan Simmons, Sr. Account Executive, Sales, H1

This presentation will discuss, best practices for measuring diversity, equity, and inclusion in a clinical trial. Also included will be practical guidance for understanding diversity outside of the United States and innovative measures for strategically infusing generative AI into clinical operations.

15:30

Long-Term Relationship Development with Clinical Research Sites

Paul Duffy, Head, Global Clinical Site Partnerships, MSD

During this session, we will review our company's approach to building long-term relationships with high-performing clinical research institutions in order to ensure development of our clinical research pipeline. Which information we use to identify and engage our high-performing sites for the long term and how we ensure that these sites were given appropriate access to our clinical research pipeline in order to optimise planning, engage with investigators to match studies and ensure delivery of high-quality data. We are now several years into this program and will share learnings and opportunities to others involved in this area.

15:55

PANEL DISCUSSION:

The Impact of Site Tech Overload on Feasibility and Study Start-Up

Alison Liddy, SVP, Patient & Site Centric Solutions, IQVIA

Chloe Rose, Global Portfolio Lead, Pratia SA

Lorenzo Parma, Director, Solution Engineering, IQVIA Technologies

Raphaelle Gilg, SSO Strategy and Operations, EMEA, Novartis

Majd Mirza, Chief Innovation Officer, Product Dev, Viedoc Technologies

Facing staffing shortages, clinical research sites are taking longer to activate and even turning down the studies they find unworkable. How can we make life easier for sites so that everyone benefits, most importantly the patients being served? In this panel discussion, leaders across the clinical trial ecosystem will discuss viable strategies to reduce the overload of technology that is contributing to site burden and staff burn-out. Can an industry approach deliver a truly vendor-agnostic, single sign-on solution?

16:20

AI-Enabled Forecasting: Increase Confidence in Study Feasibility and Execution

Rachel Horovitz, VP, Product Strategy, Medidata AI

Identifying high-performing sites is a common challenge across clinical trials. However, AI-powered solutions can now provide a competitive advantage by de-risking enrollment challenges before and during your study with improved predictive modeling. Attend this session to learn how to: Pressure test forecasting at the country and site level, provide continuously updated forecasts based on actual study enrollment rates, and identify risks like low-performing sites earlier in the trial.

16:32

Feasibility: Process Update to Ensure Active Site Engagement

Heidi Egsgaard Frandsen, Director, Indication/Program Lead, AstraZeneca

Karin Schiene, Director, Indication Program Lead, AstraZeneca

During this discussion, you will learn how AstraZeneca has made process changes and shifted the mindset of the feasibility process. We will share the process and template changes we have implemented to ensure we are actively engaged from our first interaction through site selection.

Reception in the Exhibit Hall with Beer, Wine, and Tapas16:57

Wind down at the end of a busy session day with colleagues, beer, wine, and tapas. Have a drink with your favorite exhibitor and take a chance at winning a fabulous raffle prize (must be present to win)!

Close of Day18:00

Wednesday, 30 October

Registration and Morning Coffee08:15

08:45 Chairperson's Remarks

Alison Foster, VP, Development Strategy and Growth, Fortrea

08:50

Acceleration of Interactive Response Technology: Innovative Methods to Enhance Efficiency

Cezary Bregier Director, Global Clinical Solutions, AstraZeneca

Hubert Filipczak, Director, Global Clinical Solutions, AstraZeneca Pharma Poland Sp zoo

In the context of an expanding and increasingly complex portfolio, this presentation addresses the pivotal role of setting up Interactive Response Technology (IRT) in clinical studies, without hindering patient enrollment. The session covers the entire IRT setup process, from early engagement through to system activation, emphasising the shared responsibilities of sponsors and IRT providers. Gain an overview of the IRT setup process from initial engagement to system activation. Explore sponsor and IRT provider responsibilities in the IRT setup. Gain strategies to identify and eliminate inefficiencies in the IRT setup process and techniques for driving standardisation across the setup process.

09:15

Optimizing Site Operations for Better Data Outputs: Standardizing Biospecimen Management with Digital Workflows

Ben Carmel, Chief Revenue Officer , Slope

This session will explore how digitizing and standardizing sample management at the site level enhances operations, improves collaboration, and ensures cleaner data. Attendees will learn how tech-driven workflows, such as e-requisition forms and digitized lab manuals, streamline biospecimen management, reduce errors, and accelerate trial activation. The discussion will also cover industry collaboration's role in standardizing practices, leading to optimized operations and better study outcomes.

09:40

Towards an Automated Site Feasibility with Use of Ontologies

Aditya Tyagi, Project Manager, Pistoia Alliance

The Pistoia Alliance provides a unique pre-competitive collaborative platform for pharmaceutical members and R&D service providers. The Clinical Operations Ontology project aims to automate clinical trial processes by making data machine-readable through ontologies. Site feasibility is vital for aligning protocol requirements with site capabilities, ensuring study viability. Our proof-of-concept phase targets efficiency in trial planning by enhancing the manual site feasibility process. Leveraging linked data and standard methodologies, we aim to model clinical research designs effectively. By automating processes through ontologies and existing databases, we foresee expediting decision-making and reducing redundant efforts.

Coffee Break in the Exhibit Hall10:17

More coffee, more exhibitors, more networking, and some delicious snacks. What’s not to love?

11:00

Organiser's Welcome Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

11:05 KEYNOTE PRESENTATION:

From Documents to Data: Let’s Digitally Transform Our Clinical Trial Protocol

Frank Berger, MD, Expert Data & Analytics Solutions, Clinical Development & Operations, Boehringer Ingelheim

A massive, fundamental change is knocking on the door: the shift from a document-based to a data-based, machine-readable Clinical Trial Protocol. This talk shares some insights for exploring this new territory, including pitfalls and the need for a cross-functional approach.

11:20 KEYNOTE PANEL DISCUSSION:

Integrating Digital Health Technologies in Clinical Trials: A New Era for eCOA and ePRO

PANEL MODERATOR:

Moe Alsumidaie, Chief Editor, Editorials, Clinical Trial Vanguard

This panel will delve into how emerging digital health technologies, including eCOA and ePRO, are transforming patient data collection in clinical trials. It will cover the evolution of digital endpoints, patient-centric approaches, and the integration of these technologies into clinical research frameworks. How are digital health technologies, especially eCOA and ePRO solutions, revolutionizing data collection in clinical trials? Have they led to more patient-centric trials? What are the challenges in integrating these technologies into existing clinical trial frameworks, and how have they been overcome? What considerations should be made when selecting technology partners? Looking towards the future, how do you see digital health technologies evolving, and what implications will this have on clinical research?

PANELISTS:

Jacqueline Bowman, Co-Founder, Foundation for the Rights of Citizens with Obesity

Bernhard Glombitza, Head, Clinical Operations EMEA and LATAM, Bayer

Kai Langel, CEO, DEEP Measures

11:45 KEYNOTE PANEL DISCUSSION:

How to Build Meaningful Relationships and Shift to Patient-Led Conversations for Improved Study Design and Execution

PANEL MODERATOR:

Maria Dutarte, Executive Director, European Patients’ Academy on Therapeutic Innovation (EUPATI)

Join us for a critical exploration into the transformative approach of integrating patient insights into clinical trial protocols. This panel will explore how strong relationships and patient-led conversations can improve study design and execution, significantly easing the burden on sites and patients. Learn from experts about common pitfalls and challenges in patient engagement, gaining actionable strategies towards more effective and empathetic trials.

PANELISTS:

Jose Aibar, President, Dravet Syndrome Foundation Spain

Jacqueline Cannon, Chief Executive, The Lewy Body Society

Roger Legtenberg, PhD, Co-Founder, Partners4Patients Foundation UG

Join Your Peers for a Networking Luncheon in the Exhibit Hall12:10

Join us again for lunch in the Exhibit Hall. Last chance to visit with exhibitors you missed and to enter our final raffle!

13:10

Chairperson's Remarks

Mette Flindt Heisterberg, PhD, Competency Development Specialist, Clinical Operations Office, Global Trial Portfolio, Novo Nordisk AS

13:15

How CSLs Improved Feasibility Process Helps Study Teams Improve Their Robustness in Operational Planning

Mireille Ermens, Senior Director, Clinical Development Operations—Global Feasibility and Start-Up Support, CSL Behring

Mary Smith, Senior Director, Clinical Portfolio Execution, Seqirus A CSL Co.

Early planning and study start-up challenges are common across the industry and may cause additional burden to study teams and sites with downstream impact on recruitment, timelines, and cost. Organisational focus is required to address these challenges. During this session you will learn how CSL has improved the feasibility process to help study teams improve their robustness in operational planning.

13:40

Optimizing our Focus on Site Facing Training

Mette Flindt Heisterberg, PhD, Competency Development Specialist, Clinical Operations Office, Global Trial Portfolio, Novo Nordisk AS

In the past year, Novo Nordisk has meticulously optimised site-facing training, emphasising user-centric learning journeys. By establishing a dedicated site learning unit and refining processes, we have set the stage for best-in-class learning experiences. Shifting our focus, we aim to deliver flexible, engaging learning experiences for our site staff, including understanding the shift in focus for site staff training, reflecting on global challenges and solutions, exploring user-centric learning journeys, and embracing flexibility and engagement in training delivery. Join us to engage with our challenges, solutions, and reflections as we embark on this transformative journey.

14:05

AI-Driven Augmentation for Global Strategic Clinical Trial Delivery

Lee Coram, Senior Director Business Insights, PPD Clinical Research , Thermo Fisher Scientific

Dave Hiltbrand, Associate Director Data Science , PPD Clinical Research , Thermo Fisher Scientific

Jeffrey Zimmerman, Senior Director Data Science, PPD Clinical Research, Thermo Fisher Scientific

Optimizing clinical trial study delivery by reducing timelines and mitigating risk in best-fit global selection strategy and patient enrollment is a long-standing challenge of CROs and Pharma. The PPD Clinical Research Business of Thermo Fisher Scientific has nearly a decade of experience using AI and data science to meet this need. Join us to learn how we use feasibility, start-up, enrollment, and AI to empower our partners to deliver faster, higher quality, and more affordable medicine.

Session Break14:30

14:35

Clinical Research News' Best of Show Award (Sponsored by ClinEco):

Recognising Exceptional Innovation in Technologies Used by Clinical Research Professionals

Allison Proffitt, Editorial Director, Bio-IT World and Clinical Research News

The 2024 Best of Show Awards offer exhibitors of the SCOPE Summit Europe an exclusive opportunity to distinguish and highlight their products, ranging from an innovative application, technology, tool, or solution. The SCOPE community is invited to identify exceptional innovation in technologies used by life science professionals, voting on the most impactful new products of the year. Submit your entry! https://www.scopesummiteurope.com/sponsor-exhibitor/best-of-show-awards

14:40 FIRESIDE CHAT:

Redefining Excellence: The Future of Clinical Trial Quality

Coleen Glessner, Executive Vice President, Quality, Ethics and Compliance, Emergent BioSolutions

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

Patricia Leuchten, Founder & CEO, Diligent Pharma

Shyard Wong, Head, Clinical Quality & Continuous Improvement, Sanofi

This keynote explores milestones that have shaped our present approach to clinical trial quality; how standards for excellence are evolving; and what the future holds for clinical trial quality. Patty Leuchten, Founder and CEO of Diligent Pharma, will moderate a fireside chat with industry leaders: Coleen Glessner, Executive Vice President, Quality, Ethics, and Compliance from Emergent BioSolutions; and Shyard Wong, Global Head, Clinical Quality and Continuous Improvement from Sanofi.

15:05

PLENARY PRESENTATION: Use Case: From Theory to Therapy—Accelerating Clinical Trials with AI

Jonathan Crowther, PhD, Head Predictive Analytics, PRD (OARS), Pfizer Inc.

An exploration of the future potential of GenAI in clinical trials, focusing on optimising trial efficiency, reducing costs, and the broader business impact. Inspire the audience to think about the long-term benefits of integrating GenAI into their processes.

15:20 KEYNOTE PANEL DISCUSSION:

Data to Decisions: GenAI's Role in Transforming Clinical Trials

PANEL MODERATOR:

Allison Proffitt, Editorial Director, Bio-IT World and Clinical Research News

Artificial intelligence, data analytics, automation, and technology have the power to connect stakeholders and applications and enhance protocol design, study feasibility, and patient identification and recruitment. The recent explosion of innovation with generative AI is delivering promising advances as we all know. However, this involves constructing a robust data infrastructure, harnessing cutting-edge technologies, adhering to privacy and data security regulations, and enforcing data governance principles.

PANELISTS:

Dorothee B. Bartels, PhD, Associate Professor (Apl. Professor) for Public Health and Epidemiology, Medizinische Hochschule Hannover; Founder, HealthData-Advisors, Board BBraun US

Jonathan Crowther, PhD, Head Predictive Analytics, PRD (OARS), Pfizer Inc.

Farrell Healion, Senior Director Emerging Technologies, Global Clinical Solutions, AstraZeneca

Close of Summit15:45

MONDAY AFTERNOON: USER GROUP & WORKSHOP

DATA ANALYTICS & GEN AI: NEW APPROACHES TO IMPROVE SITE SELECTION & ACTIVATION

TUESDAY MORNING PLENARY SESSION:
REINVENTING CLINICAL DEVELOPMENT & CONVERGING RESEARCH WITH CLINICAL CARE

SPONSOR/SITE COLLABORATION: SUPPORTING SITES TO IMPROVE RECRUITMENT, RETENTION, AND PERFORMANCE

TECHNOLOGIES AND PROCESSES TO IMPROVE FEASIBILITY, ACTIVATION, AND OPERATIONS

WEDNESDAY MORNING PLENARY SESSION:
INTEGRATING DIGITAL HEALTH TECH IN TRIALS & IMPROVING STUDY DESIGN WITH PATIENTS

REDUCING SITE BURDEN TO OPTIMISE OPERATIONS

WEDNESDAY AFTERNOON PLENARY SESSION:
NEW ERA OF RISK/QUALITY (R3) & LEVERAGING AI TO ACCELERATE TRIALS

MONDAY AFTERNOON: USER GROUP & WORKSHOP

DATA ANALYTICS & GEN AI: NEW APPROACHES TO IMPROVE SITE SELECTION & ACTIVATION

TUESDAY MORNING PLENARY SESSION: REINVENTING CLINICAL DEVELOPMENT & CONVERGING RESEARCH WITH CLINICAL CARE

SPONSOR/SITE COLLABORATION: SUPPORTING SITES TO IMPROVE RECRUITMENT, RETENTION, AND PERFORMANCE

TECHNOLOGIES AND PROCESSES TO IMPROVE FEASIBILITY, ACTIVATION, AND OPERATIONS

WEDNESDAY MORNING PLENARY SESSION: INTEGRATING DIGITAL HEALTH TECH IN TRIALS & IMPROVING STUDY DESIGN WITH PATIENTS

REDUCING SITE BURDEN TO OPTIMISE OPERATIONS

WEDNESDAY AFTERNOON PLENARY SESSION: NEW ERA OF RISK/QUALITY (R3) & LEVERAGING AI TO ACCELERATE TRIALS

TUESDAY MORNING PLENARY SESSION:
REINVENTING CLINICAL DEVELOPMENT & CONVERGING RESEARCH WITH CLINICAL CARE

WEDNESDAY MORNING PLENARY SESSION:
INTEGRATING DIGITAL HEALTH TECH IN TRIALS & IMPROVING STUDY DESIGN WITH PATIENTS

WEDNESDAY AFTERNOON PLENARY SESSION:
NEW ERA OF RISK/QUALITY (R3) & LEVERAGING AI TO ACCELERATE TRIALS