Feasibility and Site Selection
Data Informed Feasibility & Investigator Selection
13/10/2026 - 14 October 2026 ALL TIMES CET (UTC +2h)
Identifying the right sites is a critical, upstream decision that shapes trial timelines, enrollment success, and overall study execution. As regulations evolve and data availability varies across European health systems, traditional feasibility approaches are no longer sufficient. This track highlights how organisations are modernising feasibility and site selection using real-world data, predictive analytics, and improved data governance to better assess site capacity, patient availability, and the competitive landscape. Sessions will explore inclusive, regionally appropriate frameworks for identifying patient populations and aligning protocol requirements with real-world site capabilities. Attendees will gain practical insights into making smarter, data-informed site selection decisions that reduce uncertainty and set trials up for success from the start.

Monday, 12 October

Registration Open

MONDAY AFTERNOON WORKSHOPS & USER GROUP (IN-PERSON ONLY)

– 15:15 OPEN WORKSHOP 2: Fixing Study Start-Up and Recruitment in Europe: Feasibility, Site Selection, and Data-Driven Enrollment Planning (Sponsorship Opportunity Available)

– 18:00 WORKSHOP 1: Capital & Innovation at SCOPE Europe: Investing in the Next Generation of Clinical Trial Technology and Operations*

NEW THIS YEAR! Click here for additional details and workshop programming. *Separate registration required

– 16:45 OPEN WORKSHOP 3: AI, Digital Twins and Connected Insights: The Future of Clinical Trials Is Here—Sponsored by: ZS Associates

– 18:45 OPEN WORKSHOP 4: ICH E6(R3) in Practice: Redesigning Clinical Trial Execution, Quality, and Oversight (Sponsorship Opportunity Available)

Join friends and colleagues for dinner at a spot near the conference hotel, which is in a great location:

https://www.scopesummiteurope.com/travel 

Main Conference Tuesday and Wednesday, 13-14 October 2026. Join the morning run/walk at 06:45. Registration opens at 07:45, and the opening presentations start at 08:40.

Tuesday, 13 October

MORNING FUN RUN, COFFEE, AND CONFERENCE SESSIONS

SCOPE Europe Fun Run

RUN COORDINATOR: 

Bridget Kotelly, Senior Conference Director, Cambridge Healthtech Institute

Start your Tuesday with the SCOPE Europe Fun Run! Join fellow attendees for an informal run, jog, or walk at your own pace. Meet in the front lobby near the concierge at 06:45 sharp, and don’t forget your sneakers!

Registration and Morning Coffee

Organiser's Welcome Remarks

BUILDING BETTER FEASIBILITY FOUNDATIONS

From Fragmentation to a National Operating Model: How the UK Achieved Reliable 150-Day Commercial-Trial Set-Up

Photo of Maria Koufali, PhD, Life Sciences Industry Director, NIHR Industry Hub, NIHR National Institute of Health and Care Research , Dir Life Sciences Industry , Life Sciences Industry , NIHR Natl Institute for Health & Care Research
Maria Koufali, PhD, Life Sciences Industry Director, NIHR Industry Hub, NIHR National Institute of Health and Care Research , Dir Life Sciences Industry , Life Sciences Industry , NIHR Natl Institute for Health & Care Research

Countries compete for commercial clinical trials but most operate through fragmented infrastructures that create unpredictable timelines. The UK has implemented a coordinated national delivery model—the NIHR Industry Hub—aligning regulators, health systems and research infrastructure around a single pathway. This session explains how a whole-system approach enabled consistent 150-day study set-up at scale, and what other health systems can replicate to improve reliability, sponsor confidence and patient access.

Designing Site Networks for Registrational Potential: Lessons from the Academic CRO Model

Photo of Charles Craddock, CBE, FRCP (UK), FRCPath, DPhil, FMedSci  Professor of Haemato-oncology, University of Warwick Academic Director Centre for Clinical Haematology; Chair, UK AML Research Network , Prof , Ctr for Clinical Haematology , Queen Elizabeth Hospital
Charles Craddock, CBE, FRCP (UK), FRCPath, DPhil, FMedSci Professor of Haemato-oncology, University of Warwick Academic Director Centre for Clinical Haematology; Chair, UK AML Research Network , Prof , Ctr for Clinical Haematology , Queen Elizabeth Hospital

Academic CRO and ARO models are increasingly important in the delivery of trials with registrational potential, especially where rapid feasibility, site engagement, and complex operational support are required. This presentation will examine how networked trial delivery platforms can improve site selection and activation by combining centralized coordination, embedded acceleration networks, and direct access to clinical expertise. It will also discuss why commercially competitive not-for-profit models are gaining traction in the US and Europe, and how reinvesting surplus into research infrastructure can strengthen long-term trial capacity. Attendees will gain practical insight into how these models support faster trial setup, more effective feasibility assessment, and more sustainable delivery of registration-enabling studies.

Panel Moderator:

PANEL DISCUSSION:
Measuring What Matters: Connecting Feasibility, Site Selection, and Operational Insights

Photo of Lydia Matombo, BSN, RN, PMP, ACRP-CP, Associate Director, Sumitomo Pharma , Clinical Operations, RBQM & Data Quality Governance Leader , Clinavence
Lydia Matombo, BSN, RN, PMP, ACRP-CP, Associate Director, Sumitomo Pharma , Clinical Operations, RBQM & Data Quality Governance Leader , Clinavence

Panelists:

Photo of Łukasz Bojarski, Executive Director, Centralized Monitoring & Risk-Based Quality Management, AstraZeneca , Executive Director , Centralized Monitoring & Risk Based Quality Management , AstraZeneca
Łukasz Bojarski, Executive Director, Centralized Monitoring & Risk-Based Quality Management, AstraZeneca , Executive Director , Centralized Monitoring & Risk Based Quality Management , AstraZeneca
Photo of Naveen KK, Vice President & Global Head, CMR, CM & Safety Services, Fortrea , Executive Director & Global Head, Central Monitoring, Medical Data Review, Clinical Trial Safety , Labcorp
Naveen KK, Vice President & Global Head, CMR, CM & Safety Services, Fortrea , Executive Director & Global Head, Central Monitoring, Medical Data Review, Clinical Trial Safety , Labcorp
Photo of Emilio Neto, Global Head of Country & Site Operations, Biogen , Global Head of Country & Site Operations, Executive Director , Biogen
Emilio Neto, Global Head of Country & Site Operations, Biogen , Global Head of Country & Site Operations, Executive Director , Biogen
Photo of Viviënne van de Walle, Medical Director & Founder & Research Physician, PT&R PreCare Trial & Recruitment , Medical Dir & Founder & Research Physician , PT&R Partner in Trials & Research
Viviënne van de Walle, Medical Director & Founder & Research Physician, PT&R PreCare Trial & Recruitment , Medical Dir & Founder & Research Physician , PT&R Partner in Trials & Research

Grand Opening Coffee Break in the Exhibit Hall

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 partners, and make some new friends.

TUESDAY PLENARY SESSION:
THE FUTURE OF CLINICAL TRIALS IN EUROPE: COMPETITIVENESS, INNOVATION, AND EXECUTION

Grab Your Seat: Plenary Keynote Seat Raffle & Prize Giveaway!* (Sponsorship Opportunity Available) *Must be present to win!

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

Organiser's Welcome to SCOPE Europe

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

KEYNOTE PRESENTATION:
Shaping Innovation Pathways in Europe: The Evolving Role of Scientific Advice and Early Regulatory Engagement

Christophe Lahorte, PhD, Head, Innovation Office & Scientific Regulatory Advice Unit, FAMHP (Federal Agency for Medicines and Health Products) , Head of Innovation Office & Scientific , Regulatory Advice Unit , famhp (Federal Agency for Medicines and Health)

As Europe works to accelerate clinical development, innovation pathways and scientific advice are becoming critical tools for aligning regulators and sponsors earlier in the process. This keynote will explore how these mechanisms are evolving across Member States and at the European level, and how earlier, more structured engagement can reduce uncertainty, improve trial design, and support faster, more efficient development.

Panel Moderator:

KEYNOTE PANEL:
Can Europe Compete for the Future of Clinical Trials? Competitiveness, Regulation, and Investment

James O'Shaughnessy, Senior Partner, Newmarket Strategy; Board Member, Health Data Research UK (HDR UK); former Health Minister, UK Government , Senior Partner , Newmarket Strategy

Panelists:

Niklas Blomberg, PhD, Executive Director, Innovative Health Initiative (IHI) , Executive Director , ELIXIR Hub , Innovative Health Initiative (IHI)

Elena Bolaños, Vice President, Regional Head EMEA GCO, Johnson & Johnson , Regional Head GCO EMEA , Global Clinical Operations , Johnson & Johnson

Christophe Lahorte, PhD, Head, Innovation Office & Scientific Regulatory Advice Unit, FAMHP (Federal Agency for Medicines and Health Products) , Head of Innovation Office & Scientific , Regulatory Advice Unit , famhp (Federal Agency for Medicines and Health)

Lawrence Tallon, CEO, Medicines and Healthcare Products Regulatory Agency (MHRA) , CEO , Medicines and Healthcare Products Regulatory Agency (MHRA)

KEYNOTE PRESENTATION:
FAST EU & ACT EU in Practice: What’s Actually Accelerating Clinical Trials in Europe and What Isn’t

Stan Van Belkum, PharmD, General Secretary & CEO, Central Committee on Research Involving Human Subjects (CCMO) , General Secretary & CEO , Central Committee on Research Involving Human Subjects (CCMO)

European initiatives like FAST EU and ACT EU aim to streamline trial approval and execution, but results remain uneven across Member States. This talk will provide a candid, on-the-ground view of what is working, where bottlenecks persist, and what sponsors and regulators must change to deliver faster, more predictable study start-up in Europe.

Panel Moderator:

KEYNOTE PANEL:
Reinventing the Clinical Development Operating Model: New Models for Clinical Execution

Caroline Feys, MSc, MBA, Leader, R&D Operations Innovation, Johnson & Johnson Innovative Medicine , Leader , R&D Operations Innovation , Janssen Pharmaceutica NV

Panelists:

Tim Horlacher, PhD, Vice President & Head R&D, Strategy & Business Consulting, Bayer AG , VP, Head of Global Clinical Program Excellence , Strategy & Business Consulting , Bayer AG

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

Matthieu Ruffin, Vice President, Head Study Leadership, Novartis , VP , Head Study Leadership , Novartis

Join Your Peers for a Networking Luncheon in the Exhibit Hall

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.

DATA-DRIVEN FEASIBILITY—FROM INSIGHT TO TRUST

AI and ML-Driven Analysis of Site Performance in Clinical Trials

Photo of Clara Mella, Data Strategy Lead, Bayer AG , Data Strategy Lead , Bayer AG
Clara Mella, Data Strategy Lead, Bayer AG , Data Strategy Lead , Bayer AG

I'll share how AI and ML can enhance clinical trial site selection through a transparent, data-driven framework that evolves with every stage of the process. Topics covered include: Multi-source data integration: AI harmonises internal, external, commercial, clinical, real-world, and ad hoc data into a unified analytical catalogue; Interpretable modelling: Glass-box models, not black boxes, transparently rank sites, enabling stakeholders to understand and trust the outputs; Iterative refinement: Feasibility outreach data is fed back into the model, dynamically updating site rankings; and Actionable insights: Bridging predictive analytics with ground-truth site intelligence for better-informed decisions.

Panel Moderator:

PANEL DISCUSSION:
Increasing Transparency & Trust in Site Selection

Photo of Viviënne van de Walle, Medical Director & Founder & Research Physician, PT&R PreCare Trial & Recruitment , Medical Dir & Founder & Research Physician , PT&R Partner in Trials & Research
Viviënne van de Walle, Medical Director & Founder & Research Physician, PT&R PreCare Trial & Recruitment , Medical Dir & Founder & Research Physician , PT&R Partner in Trials & Research

Panelists:

Photo of Mireille Ermens, Senior Director, Clinical Development Operations—Global Feasibility and Start-Up Support, CSL Behring , CSL
Mireille Ermens, Senior Director, Clinical Development Operations—Global Feasibility and Start-Up Support, CSL Behring , CSL
Photo of Amy Froment, Head, Study Start-Up & Feasibility, Jazz Pharmaceuticals , Head of Feasibility and Study Start-Up , Global Clinical Development Operations , Jazz Pharmaceuticals
Amy Froment, Head, Study Start-Up & Feasibility, Jazz Pharmaceuticals , Head of Feasibility and Study Start-Up , Global Clinical Development Operations , Jazz Pharmaceuticals
Photo of Kayleigh Rogers, Director, Business Development, Clinical Services, QPS Holdings , Dir Bus Dev for Clinical Svcs , Bus Dev for Clinical Svcs , QPS Holdings
Kayleigh Rogers, Director, Business Development, Clinical Services, QPS Holdings , Dir Bus Dev for Clinical Svcs , Bus Dev for Clinical Svcs , QPS Holdings

Reception in the Exhibit Hall with Beer, Wine, and Tapas

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 Day

Wednesday, 14 October

Registration and Morning Coffee

ACCELERATING SITE SELECTION THROUGH DATA, AI & OPERATIONAL STRATEGY

Chairperson's Remarks

Stathis Stathelos, Senior Director, Feasibility and Portfolio Delivery, Oncology, AstraZeneca , Sr Director Feasibility and Portfolio Delivery , Oncology , AstraZeneca

From Decision to Activation: How a Biotech Built a High-Velocity Site Selection Engine

Photo of Pilar De la Rocha Mur, Vice President & Head, EMEA & Global Clinical Operations, BeOne Medicines , VP & Head , EMEA & Global Clinical Operations , BeOne Medicines
Pilar De la Rocha Mur, Vice President & Head, EMEA & Global Clinical Operations, BeOne Medicines , VP & Head , EMEA & Global Clinical Operations , BeOne Medicines

Site activation remains a critical bottleneck in clinical development, delaying patient access and increasing pressure on biotech organisations. In this session, attendees will gain a fresh perspective on how a biotech is redefining feasibility and site selection to dramatically accelerate activation timelines and improve trial performance. Discover how smarter upstream decisions can unlock faster execution, improve efficiency, and give clinical operations a true competitive edge in today’s dynamic environment.

Centaur—The Site-First Platform: Where Operational Efficiency Meets Human Expertise

Photo of Erbin Lim, Global Product Development Study Optimization, Global Study & Site Operations, Pfizer , Director , Site Intelligence , Pfizer
Erbin Lim, Global Product Development Study Optimization, Global Study & Site Operations, Pfizer , Director , Site Intelligence , Pfizer
Photo of Nadia Lim, Feasibility Strategy & Analytics Group Lead, Pfizer , Feasibility Strategy & Analytics Group Lead , Feasibility Strategy & Analytics , Pfizer Inc
Nadia Lim, Feasibility Strategy & Analytics Group Lead, Pfizer , Feasibility Strategy & Analytics Group Lead , Feasibility Strategy & Analytics , Pfizer Inc
Photo of Ana Maria Sanchez De La Nava, Feasibility Strategy & Analytics Lead, Pfizer , Feasibility Strategy & Analytics Lead , Pfizer
Ana Maria Sanchez De La Nava, Feasibility Strategy & Analytics Lead, Pfizer , Feasibility Strategy & Analytics Lead , Pfizer

We explore the innovative platform Pfizer developed to streamline feasibility and site selection decisions, using a data-led, site-centered approach. The platform consolidates and transforms the data into actionable strategies, allowing to anchor decision-making at the site level while scaling an AI-driven strategy that still values expert judgment. With this approach, Pfizer aims to bring efficiency into the decision, without losing the valuable input from our ultimate partners: the sites.

Bedrock to Frontier: How a Feasibility Foundation Unlocked an AI Ecosystem

Photo of Stathis Stathelos, Senior Director, Feasibility and Portfolio Delivery, Oncology, AstraZeneca , Sr Director Feasibility and Portfolio Delivery , Oncology , AstraZeneca
Stathis Stathelos, Senior Director, Feasibility and Portfolio Delivery, Oncology, AstraZeneca , Sr Director Feasibility and Portfolio Delivery , Oncology , AstraZeneca

Sustainable AI adoption in clinical feasibility is not a technology problem—it is a sequencing problem. At AstraZeneca, we built the foundation first: reframing feasibility as a strategic capability, standardising our data, and embedding robust process across our oncology portfolio. This session shares how that bedrock is now enabling a genuine AI-augmented feasibility ecosystem—and what we learned along the way.

Coffee Break in the Exhibit Hall

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

Chairperson's Remarks

Amy Froment, Head, Study Start-Up & Feasibility, Jazz Pharmaceuticals , Head of Feasibility and Study Start-Up , Global Clinical Development Operations , Jazz Pharmaceuticals

Join your Peers for a Networking Luncheon in the Exhibit Hall

Join us again for lunch in the Exhibit Hall. Last chance to visit with exhibitors you missed and to enter our final raffle! Clinical Research News' Best of Show Award will be presented.

SITE-CENTERED FEASIBILITY & HUMAN EXPERTISE

Listening beyond the Numbers: Using Qualitative Insights to Understand Patient and Site Burden

Photo of Marcus J. Duff, Feasibility Manager, Biogen , Feasibility Mgr , Feasibility , Biogen
Marcus J. Duff, Feasibility Manager, Biogen , Feasibility Mgr , Feasibility , Biogen

Quantitative assessments of patient and site burden provide only a partial view. Incorporating qualitative insights from patients, caregivers, and sites reveals the true drivers of burden. This presentation explores how qualitative feedback has been integrated into burden reporting, enabling deeper, more meaningful evaluation of protocol design and supporting more informed, patient, and site-centered decisions.

Flipping the Script: From CRO Risk to Site Accountability

Photo of Daphne Hazell, CEO, Primary Care Research Alliance , CEO , Primary Care Research Alliance
Daphne Hazell, CEO, Primary Care Research Alliance , CEO , Primary Care Research Alliance

This session explores a new AI-enabled feasibility model that shifts accountability from sponsors and CROs to sites themselves. Drawing on a digital network covering one-third of UK research-active practices, attendees will learn how AI validates recruitment plans, capacity, demographics, performance history, and operational readiness before human review begins. By requiring sites to prove feasibility upfront, this approach reduces start-up timelines, limits inflated capability claims, and creates a faster, more transparent site selection process.

Transition to Plenary Keynote

WEDNESDAY PLENARY SESSION:
THE FUTURE OF CLINICAL OPERATIONS: AI, SITE STRATEGY, AND NEW OPERATING MODELS

Organiser's Remarks: Seat Raffle and Prize Giveaway* (Sponsorship Opportunity Available) *Must be present to win!

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

KEYNOTE PRESENTATION:
AI-Driven Computational Twins in Clinical Research: Simulating Feasibility, Site Performance, and Trial Operations

Robert McGregor, PhD, Executive Director, AI Program Head, Novartis , Executive Director, AI Program Head , Development , Novartis Pharma AG

AI-driven computational twins are transforming clinical trial operations by simulating feasibility, site performance, enrollment dynamics, and operational risks before study launch. Combining historical and real-time data, these models enable scenario testing, predictive forecasting, and faster operational decisions. This talk explores how AI-powered simulations can improve trial planning, optimise site strategies, reduce delays, and enhance efficiency across clinical research programs.

KEYNOTE PRESENTATION:
When Investigator Sites Choose Sponsors: The Silent Shift Reshaping Clinical Operations

Nick Hodges, Senior Vice President & Head, Clinical Development Operations & R&D Transformation Office, Ipsen , SVP, Head of Global Clinical Development , Global Clinical Operations , Ipsen

As competition for sites, investigators, and patients intensifies, the traditional sponsor-driven model of trial execution is shifting. Increasingly, high-performing sites are selecting sponsors based on operational efficiency, burden, and partnership quality. This talk will explore how mid- and large pharma organizations are rethinking clinical operations, redefining the role of CRAs, and introducing new functions / enhanced roles to improve site engagement and execution at scale.

Panel Moderator:

KEYNOTE PANEL:
Sites and Sponsors: Reducing Site Burden and Operational Friction

Andrew Ustianowski, MD, Network Director, NIHR Research Delivery Network (RDN) , Network Director , NIHR Research Delivery Network (RDN)

Panelists:

Candice Fitzgerald, Corporate Vice President, Clinical Operations, Novo Nordisk , Vice President , Clinical Operations , Novo Nordisk

Terttu Haring, MD, Global Head, Engagement Strategy (Sites & Patients), Johnson & Johnson Innovative Medicine , Global Head, Engagement Strategy (Sites & Patients) , Johnson & Johnson Innovative Medicine

Nick Hodges, Senior Vice President & Head, Clinical Development Operations & R&D Transformation Office, Ipsen , SVP, Head of Global Clinical Development , Global Clinical Operations , Ipsen

Viviënne van de Walle, Medical Director & Founder & Research Physician, PT&R PreCare Trial & Recruitment , Medical Dir & Founder & Research Physician , PT&R Partner in Trials & Research

Closing Remarks and Next Steps

Micah Lieberman, Executive Director, SCOPE, Cambridge Healthtech Institute , Executive Director , Cambridge Healthtech Institute

Close of Conference


For more details on the conference, please contact:

Bridget Kotelly

Senior Conference Director

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781-972-5404

Email: bkotelly@cambridgeinnovationinstitute.com

 

For sponsorship information, please contact:

 

Companies A-E:

Ilana Quigley

Director, Sales

Cambridge Healthtech Institute

Phone: (+1) 857-636-2334

Email: iquigley@healthtech.com

 

Companies F-N:

Katelin Fitzgerald

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: (+1) 781-247-1824

Email: kfitzgerald@cambridgeinnovationinstitute.com

 

Companies O-V:

Jon Stroup

Lead Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-5483

Email: jons@healthtech.com

 

Companies W-Z:

Patty Rose

Senior Director, Sales

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781-972-1349

Email: prose@healthtech.com

 

For media and association partnerships, please contact:

Rich Handy

Associate Vice President, Marketing

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781-972-5456

Email: rhandy@healthtech.com