15th Annual Outsourcing in Clinical Trials Europe 2025

Creating a collaborative environment where pharma & biotech leaders can find solutions to current challenges through innovations and partnerships

29 - 30

April

2025
  • Barcelona, Spain
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • 2025 Sponsors
  • Media Centre
  • Why partner?
  • Resources
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Featured Speakers

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Mats Sundgren​

PhD, European Institute of Innovation through Health Data (i-HD)

Mats Sundgren, PhD, MSc, is a renowned expert in Health Data Strategy for Industry and Academia. With over 37 years in the pharma industry (Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science and Data Science & AI), Mats is at the forefront of industry technology innovation. In 2022, following a 12-year tenure as global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats’ new portfolio encompasses the roles of Senior Industry Scientific Director for the i~HD (European Institute for Innovation through Health Data); Executive Strategic Advisor for IgniteData, developer of a system-agnostic EHR-to-EDC solution for clinical trials; and Chairman of the Board of the Research Foundation IMIT (Institute of Managing Innovation and Technology) across Chalmers University of Technology, Royal Institute of Technology, Lund University of Technology & Stockholm School of Business.

Mats has authored over 70 publications, books, and patents in Science, Economics & Social Science (Health Data Science, Clinical Science, Business Modelling, Innovation & Creativity Management, and Device development).

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Francis P. Crawley​

Executive Director , Good Clinical Practice Alliance - Europe (GCPA)

Francis P. Crawley is a philosopher with a career in bioethics and expertise in research policy, regulation, ethics, integrity & methodology as well as in data/AI/virtual twins ethics and law with particular attention to the life sciences: clinical trials, genomics/omics, new technologies. Expertise in EU, US, international and country-specific ethics, law, and patient and community interests in health-related research. Strong experience working closely with patients, communities, researchers, and policymakers across disciplines. domains, and geographic regions in establishing consortia, developing patient registries, contributing to the development of biobanks, drafting data management and data protection plans, and contributing to building data repositories. A strong background in the methodologies for designing and reviewing health-related research supported by effective communication and leadership skills as well as diplomacy with the ability to influence changes in bioethics and law. Additional strong background in the development of research, guidance, and ethics related to global diseases affecting resource-poor settings and orphan diseases in the context of leading and/or contributing to challenging projects. Wide experience (e.g., UNAIDS, WHO, UNESCO, European Commission, Council of Europe, and others, including local organizations and industry) in developing health-related research projects, collaborative engagements, regulatory and policy outreach, and education and training in Europe, Africa, Asia, the Americas, and Eastern Europe & Central Asia. Leading roles in the development of international and national guidelines, capacity-building, empowerment, and education programmes for health research; including GCP, ethics review systems, genetics and biobanks, and data privacy & management (a GDPR DPO), with expertise in the ELSI aspects of data AI, digital twins, and organoids. Since January 2020 highly active in the research, ethics, data sharing, and policy discussions on COVID-19, particularly in the areas of vaccines, repurposed medicines, and genetic modelling, having organised more than 40 global webinars and coordinating research across HICs and LMICs. Recently engaged in the policy, ethics, and regulation of data and AI in times of crisis. Founded and coordinates the Ukraine Clinical Research Support Initiative (UCRSI) in cooperation with leading Ukrainian, European, and international organizations. He is at the forefront of the European and global movement to reform and advance research assessment in the universities and other research institutions, with a particular emphasis on research ethics and research integrity in developing policy for data and AI in the research assessment process.

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Amelia Hursey​

Parkinson's Research Manager, Parkinson's Europe

Amelia joined the Parkinson’s Europe  team in Jan 2022 as Research Manager. Since then she has developed Parkinson’s Europe’s Research Strategy, embedding a Research Steering Group into the organisation and helping to increase the presence of Parkinson’s Europe in the clinical research world. She is also focused on bringing new initiatives to the table, such as the Parkinson’s Europe’s Engagement Network, which better connects the Parkinson’s

community with research across Europe. Parkinson’s Europe is now a partner member of EUPATI and the Critical Path for Parkinson’s as part of this action.

She has been working in the field of Neurodegenerative research since 2009 and is a Patient Organisations board member with EUPATI since Sept 2023.

She previously worked for the UK NIHR’s DeNDRoN delivering clinical trials and then at Parkinson’s UK from July 2015 as Research Participation Lead.  She was responsible for initiatives to increase research participation for people affected by Parkinson’s, health care professionals and researchers, and created the innovative Parkinson’s UK Take Part Hub and co-produced the Staying Connected toolkit in collaboration with the HRA UK.

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Mireille Ermens​

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

Mireille Ermens, is a seasoned leader in the field of clinical research and healthcare management with a rich background spanning over two decades. Armed with a degree of Socio Medical Science with distinction from the University Ghent, Belgium, Mireille brings a unique blend of expertise in biochemistry, mathematics, statistics, and preventive healthcare.

A true polyglot, Mireille is fluent in Dutch, French, and English, with proficiency in German and Spanish, reflecting a deep commitment to effective communication across diverse cultural landscapes.

With a leadership style centered around "Building Bridges with and for People," Mireille has led clinical development operations teams, navigating challenges in rare and chronic diseases, high-volume infectious diseases and seasonal vaccine environments.

Currently serving as the Senior Director of Global Feasibility and Start Up Support at CSL Limited, Mireille spearheads strategic assessments of clinical trial feasibility, facilitating optimal business decision-making through meticulous recruitment-time-cost analyses and evaluation of execution options.

Prior to this role, Mireille served as the Head of Global Site Management and Monitoring Oversight at CSL Seqirus, while advocating for global process consistency with a patient-oriented oversight agility. Mireille's extensive experience also includes senior positions at Eli Lilly and Hoffmann-La Roche.

Mireille began her career as an ICU Coordinator in Intensive Care at the University Hospital, Ghent, monitoring and caring for patients post-cardiac surgery, demonstrating a commitment to hands-on patient care.

With a career trajectory marked by innovation, strategic vision, and a relentless pursuit of excellence, Mireille is a dynamic speaker who brings a wealth of knowledge and expertise to any discussion on clinical research, healthcare management, and leadership in the pharmaceutical industry.

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Laia Bisbal Arnal​

Open Classroom Coordinator, EUPATI

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Hilde Vanaken​

Head EFGCP, eConsent Initiative, European Forum for Good Clinical Practice (EFGCP)

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Astrid Pañeda Rodríguez​

Senior Director Clinical Operations, Forge Biologics

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Juan Ruiz​

VP, Medical Affairs, Forge Biologics

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Patricia Ripoll Ros​

President, Fundación Visible

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Carlos Palacios​

Associate Director, Clinical Operations, Oncology, Gilead Sciences

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Revati Tatake​

Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

Revati Tatake, PhD, is the Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData Healthcare.  Revati has over 25 years of multidisciplinary experience in academic research and the healthcare industry, both on the client and agency sides of the business. Previously she worked as a VP of Databases and Analytics at GlobalData, where she made significant contributions to Pharma Intelligence Center. Before joining GlobalData, Revati worked at Citeline/Informa, where she was involved in competitive intelligence and analytics of clinical trials and drugs in the areas of Autoimmune/Inflammation, Central Nervous System, and Ophthalmology.  Earlier, Revati worked at Boehringer Ingelheim Pharmaceuticals for over 12 years as Senior Scientist to Senior Principal Scientist, where she led drug discovery projects involving traditional high-throughput screening, as well as innovative approaches for gene and cell therapies. She also worked at Boehringer Ingelheim as a Director of Competitive Intelligence for projects in cardiometabolic space and research beyond borders. She is a co-inventor on many issued US patents related cell and gene therapies and has several publications in peer reviewed scientific journals. Revati holds a PhD in Tumor Immunology from the Tata Cancer Research Institute in Mumbai, India. She did her postdoctoral fellowship at the University of Connecticut Health Center and Boehringer Ingelheim.

 

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Sandra Sistiaga Hernando​

Site Engagement Lead, GSK

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Olga Martinez-Casares​

Director Risk Management and Management Monitoring Europe and Emerging Markets, GSK

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Sarah Bischof​

Head of Clinical Development, invIOs

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Dr. Fabian Kreimendahl​

Associate Director, Medical Evidence Biostatistics, Johnson & Johnson Innovation Medicine

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Puja Runa Myles​

Director, Clinical Practice Research Datalink (CPRD), MHRA

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Ruth Lopez Magdaleno​

Director DU Clinical Quality Program Lead, Novartis

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Marcin Rzepus​

Strategic Procurement Manager, R&D, Polpharma

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Martin Rodriguez​

Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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Cornelia Baumgartner​

Head of Clinical Operations, T-CURX

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Joanna Florek-Marwitz​

Head Risk Management and Data Quality, UCB

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Julio de la Torre​

Associate Professor of Oncology Research, Universidad Pontificia Comillas, and Advocacy Working Group Member, European Oncology Nursing Society (EONS)

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    2025 Sponsors Include:

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    Company Information

    Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 35,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,300 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

    Company Website

    To learn more, please visit our website - https://www.medidata.com

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    Company Information

    ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

    Company Website

    To learn more, please visit our website - http://www.arensia-em.com/

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    Company Information

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

    Company Website

    To learn more, please visit our website - http://www.iconplc.com/

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    Company Information

    IQVIA Technologies help you transform your clinical trials and improve patient safety with SaaS-based applications and tech-enabled services designed to streamline processes, improve workflows, and effectively engage and inform patients. The Orchestrated Clinical Trials (OCT) platform eases the burden on your sites and makes it easier and more appealing for patients to enroll and remain engaged, produces faster trials to database lock, and speeds time to market. For more information visit www.iqvia.com/oct or email us at OrchestrateYourTrials@iqvia.com

     

    Company Website

    To learn more, please visit our website - www.iqvia.com

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    Company Information

    Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase.

    Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006.

    The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.

    For more information or to speak to an expert team member visit www.Novotech-CRO.com

    Company Website

    To learn more, please visit our website - www.novotech-cro.com

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    Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

    Company Website

    To learn more, please visit our website - https://www.worldwide.com

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    Company Information

    PCM Trials has been at the forefront of decentralized clinical research since 2008, leading mobile visits and recently introducing community-based research sites. We are driving the shift to patient-centric clinical trials, giving individuals the flexibility to engage in research studies in ways that work best for them. Our approach expands opportunities for participation, resulting in greater patient diversity, reduced patient dropout, and faster study results.

    Company Website

    To learn more, please visit our website - http://www.pcmtrials.com/

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    Company Information

    1MED, is the leading European MedTech specialized solutions provider,
    offering end-to-end development expertise within the medical device, novel technology and combination products fields.

    Founded in 2014, with headquarter in Agno, Switzerland, and employing 100+ professionals across the Europe, 1MED’s mission is to support all the MedTech organizations in facing the complexity associated with the development of innovative medical devices in compliance with MDR.

    Such support may include providing preclinical support, regulatory advice, clinical study management, post marketing support, digital solutions and quality management systems across the clinical research continuum with a cross-functional approach which led to win the certification and certification maintenance of more than 500 different medical devices within the last 5 years.

    Company Website

    To learn more, please visit our website - https://www.1med.ch/

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    Company Information

    EMIS Recruit is an integrated solution that connects Research, Life Sciences and healthcare by embedding clinical research recruitment tools directly into the point of care systems.  EMIS recruit gives research organisations clear visibility of clinically relevant patients based on your study protocol. This enables us to provide you with qualified patients that streamline your recruitment process

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    Company Information

    Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company’s Net Promoter Score (NPS) consistently exceeds the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 1,000 trials across 80 countries.

    Company Website

    To learn more, please visit our website - https://www.suvoda.com/

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      Why attend?

      Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 29th-30th April 2025!

      For the 15th Annual event, our flagship European clinical show will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials.

      This conference will bring leading industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, and technology.

      WHAT TO EXPECT FOR 2025?

      With regulations ever changing and the innovative advancements of technology rapidly growing, this conference will address the everyday and perspective challenges faced when working within the clinical trial space. Legislations such as the CTIS review to Generative AI and leveraging our global trial footprint to accelerate clinical development, as well as building on our new and existing relationships within our industry.

      This conference will bring industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, technology and of course, patient centricity.

      This is a unique opportunity to network and share knowledge with the region’s leading pharmaceutical firms, biotech’s and medical device companies, to discuss operationally efficient, specifically targeted clinical trials. The 2025 program boasts 4 full streams complete with key content.

      Stream A: Outsourcing & Clinical Operations

      Stream B: Clinical Innovation & Technology

      Stream C Day 1: Patient Centricity

      500+

      Attendees

      		80+

      Exhibitors

      		40+

      Speakers
      500+

      Attendees

      		80+

      Exhibitors
      40+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 7 May 2024
      • 8 May 2024
      Expand All

      Streams

      Stream one

      Stream A: Clinical Operations and Outsourcing

      Stream two

      Stream B: Clinical Technology & Innovation

      Stream three

      Stream C: Patient Centricity

      11 AM

      Enhancing Patient-Centricity in Clinical Trials: A Collaborative Approach

      This session will explore how patient centricity, engagement, and incorporating the patient voice can transform clinical trials.

      • Understanding the concept of patient centricity and its importance in designing and conducting trials.
      • Explore how patient involvement can enhance trial design, improve recruitment, and ensure adherence.
      • Highlighting the value of capturing patient insights to identify and address barriers in trial participation.
      • Discuss methods for incorporating patient feedback in protocol design, consent processes, and study execution.
      • Building Collaborative Networks, Examine the roles of investigational sites, industry sponsors, and regulators in fostering a patient[1]centric approach. • Identify best practices for stakeholder collaboration to streamline trial processes while keeping patients at the forefront

      Speakers

      Patricia Ripoll Ros
      President, Fundación Visible

      11:30 AM

      Reserved for event sponsor

      Speakers

      Esther Marfo
      Project Leader, Health Equity And Population Sciences, Hoffman La Roche

      12 PM

      Patient Centricity in Clinical Development; what & how?

      Explore the principles and practices of patient-centric approaches in clinical trials and discuss their practical application to enhance trial design, execution, and outcomes.

       

      Speakers

      Estrella Garcia PhD
      Executive Director Global Clinical Operations, Almirall

      12:30 PM

      Advancing Clinical Trials for Rare Diseases: Innovative Gene Therapy Solutions

      • Overview of Rare Diseases
      • Designing Clinical Trials for Rare Diseases
      • Overcoming Challenges in Rare Disease Trials
      • Post-Trial Consideration

      1 PM

      Lunch and networking

      2 PM

      Panel Discussion Integrating the Patient Voice in Protocol Design: Balancing Rigor, Feasibility, and Centricity

      Incorporating the patient perspective into clinical trial protocol design and endpoint selection is essential for ensuring that trials are relevant and meaningful. However, this integration presents challenges, including finding common ground among stakeholders and navigating the balance between scientific rigor and feasibility. This session will explore how pharma companies can streamline protocols while maintaining their integrity and enhancing patient engagement

      • Understand the importance of the patient voice in clinical trial design and endpoint selection.
      • Identify challenges in balancing scientific and Regulatory rigor, feasibility, and patient-centricity.
      • Explore strategies for creating streamlined protocols without compromising essential data collection.
      • Discuss best practices for enhancing collaboration within trial teams to facilitate patient-centered design

      Moderator: Estrella Garcia, Executive Global Clinical Operations Director, ALMIRALL

      Panellists: Denis Costello, Director at CML Advocates Network & Board Member

      Laia Bisbal Arnal, Open Classroom Coordinator, EUPATI

      Speakers

      Estrella Garcia PhD
      Executive Director Global Clinical Operations, Almirall
      Denis Costello
      Director, CML Advocates Network & Board Member
      Laia Bisbal Arnal
      Open Classroom Coordinator, EUPATI

      2:45 PM

      Reserved for event sponso

      3:15 PM

      The Patient’s Perspective: ‘Why are patients’ voices so imp

      • Discussing the personal experiences of the patient
      • Co-create clinical development & clinical trials with the perspective of the patients in mind
      • Evaluate Patient burdens for participation in Clinical trials.
      • Patient access to drug post study

      Speakers

      Jose Angel Aibar
      President, Dravet Syndrome Foundation Spain and Rare Disease Patient Caregiver

      3:45 PM

      fternoon refreshments and networking with Apple Prize Draw

      4:15 PM

      Reserved for event sponsor

      4:45 PM

      PANEL How minimizing participant burden leads to on-time enrollment and completion.

      • Where are the main hurdles patients face and how can these be removed?
      • Addressing low levels of health literacy in the patient population: how to improve communication
      • Engaging patients and advocacy groups early on in the clinical trial design process
      • Barriers to clinical trial participation from a patient perspective
      • Patient reimbursement: how to relieve financial pressures on patients participating in trials

      END OF DAY 1 AND NETWORKING DRINKS RECEPTION

      11 AM

      AI in Clinical Trials: Practical Implementation, Navigating Uncertainty, and Measuring Success

      This session will offer a deep dive into the practical applications of artificial intelligence (AI) within clinical trials and research settings. Moving beyond theory, we’ll focus on implementing AI solutions, addressing the challenges of navigating the unknown, and defining clear metrics to measure success.

      • Identify key AI implementation areas in clinical trials and the tools available and how can the sponsor benefit from such tools
      • Understand methods to assess and measure AI-driven initiatives’ success.
      • Learn techniques for navigating uncertainties and overcoming implementation challenges.
      • Gather and utilize feedback effectively to optimise AI solutions.

      Speakers

      Piotr Maślak
      Director, Operational Data Intelligence, AstraZeneca

      11:30 AM

      Reserved for event sponsor

      12 PM

      A Fit-for-Purpose Framework for Effective Technology Strategies in Clinical Trials

      Discover a 5-step framework to define, design, cross-check, measure, and analyze the right technology and operational execution for your clinical trials. This session highlights the eConsent Fit-for-Purpose Study Framework, developed by the non-profit European Forum GCP eConsent initiative in collaboration with over 50 organizations. Additionally, we will explore the importance of harmonized terminologies, study documents requirements, and insights into Ethics Committees’ expectations for eConsent. While focused on eConsent, this approach can be re-used for developing similar frameworks tailored to any technology or Decentralized Clinical Trial Element

      Speakers

      Hilde Vanaken
      Head EFGCP, eConsent Initiative, European Forum for Good Clinical Practice (EFGCP)

      12:30 PM

      Reserved for event sponso

      1 PM

      Lunch and networking

      2 PM

      Reserved for event sponsor

      2 PM

      Panel Discussion Embracing Innovative Technologies in Clinical Trials: Opportunities and Challenge

      Exploring how new technologies are transforming clinical trial processes, improving efficiency, and addressing challenges. The session will focus on real-world applications, benefits, potential risks, and future implications.

      • Why, historically is Pharma so slow to adopt new technologies? Averaging up to 7 years according to a 2022 Tufts Study
      • Current Innovations in Clinical Trials; How technologies like General AI and Large Language Models, prognostic and predictive deep learning, and direct data transfer (or EHR to EDC) are enhancing trial efficiency and patient outcomes.
      • Overcoming Challenges; Regulatory hurdles: How are agencies responding to new technologies?
      • Ethical considerations: Ensuring patient data privacy and compliance.
      • Operational barriers: Integration with existing trial frameworks (or do we need to adapt?)
      • Future Outlook: What technologies will dominate in the next 5–10 years? (perhaps 7-14 years considering the tech adoption cycle)
      • How can stakeholders (pharma, CROs, tech companies, regulators) collaborate effectively??

      Moderator: Dr. Fabian Kreimendahl, Associate Director, Medical Evidence Biostatistics, Johnson & Johnson Innovation Medicine

      Panelist: Paul Jacobs, Associate Director, Development Innovation, Regeneron

      Ashish Bagde, Data Management, UCB Belgium

      Speakers

      Dr. Fabian Kreimendahl
      Associate Director, Medical Evidence Biostatistics, Johnson & Johnson Innovation Medicine

      2:45 PM

      Reserved for event sponso

      3:15 PM

      Cybersecurity in Vendor Qualification

      This session will highlight the importance of cybersecurity in vendor qualification, discussing current challenges, and provide practical strategies to safeguard clinical trial data and processes.

      Speakers

      Martin Rodriguez
      Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

      3:45 PM

      fternoon refreshments and networking with Apple Prize Draw

      4:15 PM

      Reserved for event sponsor

      4:45 PM

      PANEL Building transparency to foster trust: Balancing the need for centralized and secondary data usage with the respect for patients’ ownership of their data

      • Addressing communication and transparency between sponsor and service provider
      • Addressing data privacy concerns by using synthetic healthcare data that complies with regulations • What can we do to ensure the safe handling of vast amounts of sensitive data?
      • Leveraging AI tools to adhere to data privacy regulations
      • Is the data ever fully protected and how can we measure this?

      Moderator: Dr. Fabian Kreimendahl, Associate Director, Johnson & Johnson Innovation Medicine

       

      5:30 PM

      Chairperson’s closing remarks followed by Drinks Reception

      END OF DAY 1 AND NETWORKING DRINKS RECEPTION

      7:45 AM

      Registration and refreshments

      8:20 AM

      Chairperson’s opening remarks

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

      8:30 AM

      KEYNOTE PRESENTATION WHO’s 2024 clinical trial guidance: what do I need to know

      • Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good
      Clinical Practice
      • Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial
      execution
      • Promoting data transparency and global collaboration, registering trials and sharing data to improve
      research outcomes
      • Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining
      safety and compliance

      Speakers

      Vasee Moorthy
      Senior Advisor, R&D, World Health Organization

      9 AM

      Reserved for event sponsor

      9:30 AM

      KEYNOTE PANEL Where is the clinical trial industry headed this year and beyond?

      • Navigating new regulations around clinical trials smoothly and successfully
      • The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?
      • Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to
      participate in?
      • Technological developments into 2025 and beyond: what changes can we expect to see in the next 3-5
      years?

      Moderator: Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
      Panellists: Andrzej Szandrach, Executive Director, Head of Study Management R&I, AstraZenec

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc
      Andrzej Szandrach
      Executive Director, Head of Study Management R&I, AstraZeneca

      10:30 AM

      Morning Networking & Refreshment break

      11 AM

      Transforming Sponsor-CRO Partnerships for Clinical Trial Success: Innovation, Transparency and Agility

      This session will delve into innovative approaches to sponsorCRO partnerships, with a focus on building stronger stakeholder relationships, enhancing transparency, and managing teams effectively.

      • Identify innovative processes and partnership strategies to elevate sponsor-CRO collaborations.

      • Understand the role of transparency and centralised data in fostering trust and alignment.

      • Learn how AGILE team management can improve efficiency and responsiveness in clinical trials.

      • Gain insights from a case study of a successful sponsor-CRO partnership.

      Speakers

      Andria Wilk
      Global Head of Quality, Argenx and Board Member, EFGCP

      11:30 AM

      Reserved for event sponsor

      12 PM

      Strategic Site Selection: Identifying the Right Sites, People, and Advocates for Trial Success

      Selecting the right sites and investigators is critical for successful clinical trials, especially in multidisciplinary studies. This session will explore strategies for targeting sites that align with study goals, investing in investigators who not only have the skills but also believe in the product, and leveraging key opinion leaders (KOLs) who can enhance the trial’s impact. We’ll cover key factors in recruitment, including site capability, investigator influence, and alignment with product objectives.

      • Learn strategies for identifying and selecting sites that align with trial needs and patient demographics.
      • Understand the importance of choosing investigators who are both competent and product advocates.
      • Explore the role of KOLs in influencing trial outcomes and enhancing product credibility.
      • • Discover best practices for collaborating with the study startup team to ensure smooth trial initiation.

      Speakers

      Carlos Palacios
      Associate Director, Clinical Operations, Oncology, Gilead Sciences

      12:30 PM

      Reserved for event sponsor

      1 PM

      Lunch and networking

      2 PM

      Panel Discussion Unravelling the Impact of ICH E6 Revision 3: Implementing New Standards in Good Clinical Practice

      ICH E6 (R3) introduces significant updates to Good Clinical Practice guidelines, emphasizing risk-based quality management, patient centricity, and flexibility in trial design and execution. This panel discussion will address the impact of ICH E6 (R3) on clinical trials, comparing it to the previous ICH E6 (R2), discussing approaches to implementation, and considering varied interpretations among stakeholders.

      • Understand the key changes in ICH E6 (R3) and their implications for clinical trial conduct.
      • Explore different approaches to implementing the new guidelines in diverse trial settings.
      • Analyse the challenges, opportunities, and interpretations associated with ICH E6 (R3).
      • Highlight meaningful differences between ICH E6 (R2) and ICH E6 (R3) and their practical impacts.

      Speakers

      Joanna Florek-Marwitz
      Head Risk Management and Data Quality, UCB
      Juan Ruiz
      VP, Medical Affairs, Forge Biologics
      Olga Martinez-Casares
      Director Risk Management and Management Monitoring Europe and Emerging Markets, GSK

      2:45 PM

      Reserved for event sponsor

      3:15 PM

      Interactive Workshop Session Navigating Regulatory Hurdles: Addressing Challenges in Global Clinical Trial Submissions

      • Developing a global clinical trial submission strategy.
      • Importance of regulatory compliance for successful trial submissions.
      • Understanding regional differences in requirements (e.g., IND vs. CTA).
      • Impact of local laws, ethics committee approvals, and cultural considerations.
      • Differences in clinical trial documentation requirements.
      • Managing timelines and delays in submissions.
      • Pre-submission interactions with regulatory agencies (e.g., pre-IND/Scientific Advice meetings).

      Astrid Pañeda Rodríguez, Senior Director Clinical Operations, Forge Biologics
      Maria Matilde Urdaneta Abate, Head of Medical Assessment, Clinical investigations and trials, MHRA
      PDMA Representative
      EMA Representative

      Speakers

      Astrid Pañeda Rodríguez
      Senior Director Clinical Operations, Forge Biologics

      3:45 PM

      fternoon refreshments and networking with Apple Prize Draw

      4:15 PM

      Reserved for event sponsor

      4:45 PM

      PANEL The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Europe

      • New regulations and guidance around clinical trials in the EU: how will this impact you?
      • Staff turnover and layoffs: handling changes in the industry in order to ensure success
      • Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
      • An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

      Speakers

      Sarah Bischof
      Head of Clinical Development, invIOs
      Cornelia Baumgartner
      Head of Clinical Operations, T-CURX

      5:30 PM

      Chairperson’s closing remarks followed by Drinks Reception

      END OF DAY 1 AND NETWORKING DRINKS RECEPTION

      Streams

      Stream one

      Stream A: Clinical Operations and Outsourcing

      Stream two

      Stream B: Clinical Technology & Innovation

      8:50 AM

      Chairperson’s opening remarks

      9:30 AM

      Reserved for event sponsor

      10 AM

      An overview of high-fidelity synthetic data applications

      • Defining high-fidelity synthetic data
      • MHRA approach to synthetic data generation
      • Can synthetic data be used to validate ML algorithms?
      • Can synthetic data be used for sample boosting?
      • Can synthetic data address biases due to underrepresentation?
      • Can synthetic data be used to enhance clinical trials (CTs)?
      • Regulatory considerations

      Speakers

      Puja Runa Myles
      Director, Clinical Practice Research Datalink (CPRD), MHRA

      11 AM

      Morning refreshments and networking

      11:30 AM

      Reserved for event sponsor

      12 PM

      Clinical Trial Investigations: Looking at the trends and landscape for 2024 and what we can learn from them moving through 2025 and into 2026

      • Overview of global clinical trials for 2024
      • Assessing key sponsors, top interventions and looking at the trial landscape for 2024
      • Looking at key obstacles for terminated trials and evaluation of completed trials which have achieved endpoint status.

      Speakers

      Priya Ravisekara
      Senior Analyst, GlobalData

      12:30 PM

      Lunch and networking

      1:30 PM

      PANEL Harnessing Technology: Innovations in Patient Recruitment and Retention for Clinical Trials

      As clinical trials become increasingly competitive, utilizing technology to improve patient recruitment and retention is essential for success. This panel will explore innovative methods and tools that streamline recruitment processes, leverage AI and machine learning to accelerate timelines, and engage patients through digital platforms, including social media.

      • Understand the current challenges in patient recruitment and retention in clinical trials.
      • Explore technology-driven methods to streamline recruitment and enrollment processes.
      • Analyze the role of AI and machine learning in enhancing trial efficiency and reducing costs.
      • Discuss best practices for engaging patients through social media and other digital channels.

       

      Speakers

      Mats Sundgren
      PhD, European Institute of Innovation through Health Data (i-HD)
      Puja Runa Myles
      Director, Clinical Practice Research Datalink (CPRD), MHRA

      2:30 PM

      Risk-Based Quality Management in Clinical Trials: Ensuring Compliance and Efficiency

      • This session will explore the principles, methodologies, and tools of Risk-Based Quality Management (RBQM) in clinical trials. It will focus on how a risk-based approach can enhance compliance, improve data quality, and optimize trial efficiency. Attendees will gain practical insights into risk assessment, monitoring, and mitigation strategies, with a particular emphasis on implementing RBQM frameworks in alignment with ICH E6(R3) guidelines.
        • Overview of RBQM: Concepts and Regulatory Frameworks
        • Designing a Risk Assessment and Categorization Tool (RACT)
        • Centralized and On-Site Monitoring Strategies • Leveraging Technology for Risk Management
        • Case Studies: Lessons Learned from Implementing RBQM
        • Future Trends and Updates in Regulatory Guidance

      8:10 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      9 AM

      Transforming Clinical Trials with AI and Real-World Data (RWD): A New Era of Innovation

      Key Topics Covered:

      • Introduction to the Transformative Landscape: Overview of how AI, ML, and RWD are fundamentally changing the structure and execution of clinical trials.
      • Advanced Trial Design & Digital Integration: Detailed discussion of Federated HER platforms and eSource-supported trials, showcasing their impact on operational efficiency and trial accuracy
      • AI-Driven Patient Recruitment Strategies: Exploration of unstructured data integration (clinical notes, lab reports) and its role in precise patient identification and accelerated recruitment timelines.
      • Case Studies and Real-World Applications: Presentation of practical examples, including AI-driven recruitment solutions for pharmaceutical trials and data quality improvements within the European Health Data Space (EHDS).
      • Outlook and Future Developments: Insights into emerging trends, such as increased cross[1]border collaboration, patient-centric approaches, and the evolution of AI applications in enhancing trial efficiency and global healthcare outcomes

      Speakers

      Mats Sundgren
      PhD, European Institute of Innovation through Health Data (i-HD)

      9:30 AM

      Reserved for event sponsor

      10 AM

      Navigating Phase 1 Trials: Strategies for Small Biotech’s to Overcome Financial and Resource Challenges

      Small biotech companies often face unique challenges when conducting Phase 1 clinical trials due to limited financial and human resources. This session will explore practical strategies and tools that can help these companies effectively manage their trials while navigating regulatory requirements. Attendees will gain insights into optimizing trial design, budget management, and leveraging partnerships.

      • Understand the financial challenges faced by small biotech companies in running Phase 1 trials.
      • Explore strategies for effective resource allocation and cost management in clinical trials.
      • Learn about tools and technologies that can streamline trial operations and improve efficiency.
      • Discuss regulatory considerations and compliance best practices that impact trial management.

       

      Speakers

      Sarah Bischof
      Head of Clinical Development, invIOs

      10:30 AM

      Reserved for event sponsor

      11 AM

      Morning refreshments and networking

      11:30 AM

      Reserved for event sponsor

      12 PM

      Fostering a strong Sponsor – Clinical Research Organisation relationship through knowledge sharing and innovative strategies

      • Planning for a successful sponsor/CRO relationship
      • Defining goals, priorities and metrics
      • Sharing best practice between Vendor and Sponsor to gather market knowledge.
      • Overview of common challenges and pitfalls when working with your CRO
      • Developing a detailed plan to minimise disruptions and ensure continuity

      Speakers

      Eva Torres Costa
      Director, Alliance Management, AstraZeneca

      12:30 PM

      Lunch and networking

      1:30 PM

      PANEL Navigating Uncertainty: Mitigating the Impact of External Factors on Clinical Trials in Europe

      External factors, including geopolitical tensions and global conflicts, can significantly disrupt clinical trials in Europe, affecting timelines, budgets, and patient recruitment. This session will analyze the implications of these external influences on clinical research and discuss strategies that pharma and biotech companies can employ to mitigate risks and maintain trial integrity. This session will also cover the EFPIA paper which states “60,000 fewer clinical trial places for Europeans, despite global surge in research projects. "For Europe to be competitive, it needs to function as a unified region" says Nathalie Moll.

      • Understand the impact of global conflicts and external factors on clinical trials in Europe.
      • Identify specific challenges posed by geopolitical events, regulatory changes, and market dynamics.
      • Explore strategies and best practices for mitigating risks associated with external factors.
      • Discuss the importance of adaptability and contingency planning in clinical trial management.

      Moderator: Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      Ruth Lopez Magdaleno, Director DU Clinical Quality Program Lead, Novartis

      Sandra Sistiaga Hernando, Site Engagement Lead, GlaxoSmithKline

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc
      Ruth Lopez Magdaleno
      Director DU Clinical Quality Program Lead, Novartis
      Sandra Sistiaga Hernando
      Site Engagement Lead, GSK

      2 PM

      Reserved for event sponsor

      2:30 PM

      The Debate Are CROs fit for the future of clinical trials and ready to become technology enablers?

      CROs have historically played a crucial role in advancing drug development. However, the traditional CRO model, largely based on selling "time" (e.g., CRA hours, project management oversight), is facing increasing scrutiny in an era of rapid technological advancements and evolving industry demands. Paul Jacobs will argue the case for transformative change in CRO services and business models, whilst XXX will defend the status quo as a tried and tested recipe for success.

      3 PM

      Afternoon refreshments and Apple Prize draw

      3:45 PM

      INTERACTIVE THINK TANKS

      Interactive think tank sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry. Hosted by industry experts and each focused on a single issue, think tanks are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each think tank session lasts for 30 minutes, and delegates may attend up to 2.

      Think Tank 1: Current trends in mediating patient input into clinical development programs Denis Costello, Director at CML Advocates Network & Board Member

      Think Tank 2: Site Selection and working relationships with your site to increase reliability. Sandra Sistiaga Hernando, Site Engagement Lead, GlaxoSmithKline

      Think Tank 3: DCT and Hybrid Trials Ashish Bagde, Data Management, UCB Belgium Think Tank 4: CRO Sourcing Strategies for your Clinical Trial. Marcin Rzepus, Strategic Procurement Manager, R&D, Polpharma

      4:45 PM

      Chairperson’s closing remarks

      END OF CONFERENCE

      Speakers

      Select a speaker to learn more

      Back
      Estrella Garcia PhD
      Executive Director Global Clinical Operations, Almirall

      Estrella began her ‘scientific odyssey’ at the University of Navarra, Spain, where she gained a PhD in Genetic Toxicology.  Following this, Estrella held at post-doctoral position at ICI (now Astra Zeneca) in Macclesfield, UK. At ICI Estrella’s focus was on novel anti-tumor drugs in the pre-clinical phase. Subsequently Estrella returned to Spain where she joined Almirall as a Clinical Research Scientist. Since then, Estrella has amassed a 29 year career with the company- taking on roles of increasing demand and responsibility, including Head of Allergy Therapeutic Area and Head of Clinical Development Operations- to the role she holds today.

      Estrella leads her group and is responsible for clinical trials worldwide. Since Almirall do not have affiliates fully involved in clinical development, the company externalizes all clinical trials, with a strategic focus on keeping only core competencies- particularly for pivotal studies- in-house. In this capacity Estrella has worked with dozens of CROs and service providers managing Phase I to Phase IV clinical trials of all sizes, from small single centre studies to global programs involving hundreds of sites and thousands of patients. Her responsibility is covering the selecting, negotiation, contracting, managing and final evaluation of the CROs responsible for the worldwide clinical development, in order to deliver on the agreed timelines, quality and cost.

      She has been responsible for ensuring Clinical Development for Aclidinium bromide in COPD was performed worldwide from the operational point of view on time, budget and quality, among other development from Almirall.

      Now fully focus on Dermatology development, managing trials worldwide mainly in Psoriasis, Acné, Atopic Dermatitis, Actinic Keratosis, among other indications.

      Session Details:

      Patient Centricity in Clinical Development; what & how?

      2025-04-29, 12:00 PM

      Session Details:

      Panel Discussion Integrating the Patient Voice in Protocol Design: Balancing Rigor, Feasibility, and Centricity

      2025-04-29, 2:00 PM

      View In Agenda
      Next speaker
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      Andria Wilk
      Global Head of Quality, Argenx and Board Member, EFGCP

      Session Details:

      Transforming Sponsor-CRO Partnerships for Clinical Trial Success: Innovation, Transparency and Agility

      2025-04-29, 11:00 AM

      View In Agenda
      Next speaker
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      Andrzej Szandrach
      Executive Director, Head of Study Management R&I, AstraZeneca

      Session Details:

      KEYNOTE PANEL Where is the clinical trial industry headed this year and beyond?

      2025-04-29, 9:30 AM

      View In Agenda
      Next speaker
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      Eva Torres Costa
      Director, Alliance Management, AstraZeneca

      Session Details:

      Fostering a strong Sponsor – Clinical Research Organisation relationship through knowledge sharing and innovative strategies

      2025-04-30, 12:00 PM

      View In Agenda
      Next speaker
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      Piotr Maślak
      Director, Operational Data Intelligence, AstraZeneca

      Session Details:

      AI in Clinical Trials: Practical Implementation, Navigating Uncertainty, and Measuring Success

      2025-04-29, 11:00 AM

      View In Agenda
      Next speaker
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      Denis Costello
      Director, CML Advocates Network & Board Member

      Session Details:

      Panel Discussion Integrating the Patient Voice in Protocol Design: Balancing Rigor, Feasibility, and Centricity

      2025-04-29, 2:00 PM

      View In Agenda
      Next speaker
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      Jose Angel Aibar
      President, Dravet Syndrome Foundation Spain and Rare Disease Patient Caregiver

      Session Details:

      The Patient’s Perspective: ‘Why are patients’ voices so imp

      2025-04-29, 3:15 PM

      View In Agenda
      Next speaker

      Advisory Board

      Select a member to learn more

      Back
      Bao
      Vendor Engagement and Business Operations Leader | Strategic Advisor | Clinical Data Management Expert

      With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

      Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

      Next

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