2nd Annual Clinical Data Management Innovation Europe 2025

We are pleased to announce our event 2nd Annual Clinical Data Management Innovation will be returning in 2025!

3 - 4

December

2025
  • Barcelona, Spain
  • Ticketed
  • Why attend?
  • Agenda
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • 2025 Sponsors
  • Media Centre
  • Why partner?
  • Contact Us
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Featured Speakers

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Maja Omiecińska​

Emerging Technologies Director, Global Clinical Solutions, AstraZeneca

Digital innovation business leader with vision for turning bold technology innovations into operational realities.

As Emerging Technologies Director I am accountable for the collaboration with cross functional business partners in managing the delivery of promoting solutions between test/start/scale. I am accountable for understanding the demands and implications of solutions and will ensure that the organisation has the capability and capacity to achieve business outcomes with agreement and clarity around roles and responsibility. My role is to forge relationships with internal and external partners to build best practice and establish new ways of working.

My mission is to introduce innovative technologies in AstraZeneca clinical trials, paving the way towards operational excellence.

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Nick De Donder​

CORE Product Owner , CDISC

Biography

Nick De Donder graduated as a biomedical scientist from the University of Ghent, Belgium in 2007 and has been employed since 2008 by Business & Decision Life Sciences at their headquarters in Brussels. He has been moving from being a Data Integration Specialist to Project Manager to Line Manager for the Data Standards team. Since 2020 he is Head of Data Standards. Nick is a member of the SDS team, an authorized CDISC trainer for CDASH, SDTM and Newcomers and a PHUSE committee member since 2017. In 2019 he joined the E3C and is now co-chairing it. Since June 2021 Nick has been product owner of the CORE application.

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Debarshi Dey​

Vice President, Head of Biometrics , Galapagos

Debarshi is currently Global Head of Biostatistics and Data Management consisting of approximately 30 Biostatisticians, Statistical Programmers and Data Managers across two global sites in Munich, Germany and Boston, USA for a Bio-Pharmaceutical company engaged in bringing novel drugs in Oncology and Auto-immune disease to patients.

With more than 11 years of experience in drug development in the pharmaceutical industry, Debarshi has extensive and proven track-record of impactful data-driven leadership in all phases of drug development and successful regulatory interactions regarding New Drug Application (NDA) and Biologics License Application (BLA) with USFDA, EMA, and PMDA.

Debarshi was the Lead Statistician of a pivotal oncology study with a real-world component, which resulted in a successful FDA approval in July 2020. In the course of the path to approval, Debarshi provided strategic leadership, led multiple interactions with FDA and provided strong statistical input in regulatory aspects of the submission. Debarshi has designed Phase I-III clinical trials, with complex adaptive features, calculating optimal sample size taking advantage of advanced simulation methods.

In his current role, Debarshi has been instrumental in setting up a fully functional Statistics and Data Management Department from scratch , including a CFR 21 Part 11 validated SAS programming environment for performing in-house programming.

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Dr. Jose Manuel Cervera Grau​

Executive Director , Eli Lilly and Company

Joined to the project of biotechnologies in 2012, at the beginning of the Advanced Therapies. The labour as Oncologist in Big Pharma from September of 2016 until today has been taking part of international research organizations in which participated actively; Working as a Cross-functional role for Spain and Portugal, clinical development of Lilly portfolio, deep dive of clinical trials and preclinical studies of new drugs, from First Human dose to Phase III/IV. Expert in Regulatory terms and access negotiation, in Pre-launching and Clinical Launching of drugs developing the brand plan and operational plans supporting all implicated areas, from I+D, clinical operations, to marketing and sales.

Other Qualities are management and leadership, strategy and innovation, technology, operations, and value chain management, Emotional intelligence and empathy. The road map to achieve all theses capabilities has been intense working in 10 Hospitals, in basic science, preclinical research in Advanced Therapy Medicinal Product, developing drugs from human origen from Wharthon´s jelly MSCs, fat and dental pulp to recover damaged soft tissue, chronic stroke and chemotherapy damage and been author of books papers, communications in international meetings and participating in many advanced projects nationwide health demonstrating great capacity for teamwork to solve complex situations.

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Magali Traskine​

Associate Director, Central Monitoring, GSK

Magali specialises in:

- Risk Based Quality Monitoring
- Centralized Monitoring
- Processes improvement
- Statistical optimizations
- Feasibility
- Vaccines
- Mentoring
- Coaching
- People management

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    2025 Sponsors Include:

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    Company Information

    IDDI optimizes the clinical development of drugs, biomarkers and IVD using a unique combination of advanced biostatistics and innovative data collection technology.

    IDDI covers the full spectrum of trial design, clinical data collection, management, analysis and reporting for Phase I- IV clinical trials.

    – IDDI’s services include: Clinical Development Plans, Protocol Development, Randomization (IWRS/IRT) with Drug Supply Management, EDC, Medical Coding, Data Management, Biostatistics, IDMC Support, Biomarker/Diagnostics Validation, Medical Writing.

    – IDDI’s therapeutic areas of expertise include oncology, ophthalmology, infectious diseases and cardiology.
    – Experience: 27+ years – 980+ trials (630+ in oncology) – 20 FDA/EMA approvals to-date
    – HQ in Belgium with offices in the USA ( Raleigh, NC, Boston, MA and San Francisco, CA).

    Company Website

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

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    Company Information

    Euraxi is a project management specialist in clinical research and epidemiology, assisting clients with their projects.
    Euraxi started Home Nursing activities on 2014 (over 180 projects awarded) with a dedicated nurses Team and Country Study Managers (France and affiliates in BEL/NED/DEU/ITA/SPA) working in various indication from children to elderly population.

    Company Website

    To learn more, please visit our website - https://www.euraxi.fr/en/

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      Why attend?

      This event has been exclusively designed for  cutting-edge clinical data and analytics leaders in Europe, and will focus on designing your clinical data strategy, leveraging data analytics to maximize the use of your data, and using data effectively when preparing for regulatory submission. Topics will include working with sites to make data entry and collection as easy as possible, the uses of real world evidence, and understanding the European regulatory environment surrounding clinical data.

      We look forward to seeing you there!

      A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES

      The programme will feature a range of speakers from the likes of Bristol Myers Squib, Otsuka, Cerevel Therapeutics, Merck, Daiichi Sankyo and many more, who through a variety of interactive session formats will offer insight on promoting successful clinical data management.

      Testimonials

      See What It's All About

      Agenda

      • 3 Dec 2025
      • 4 Dec 2025
      Expand All

      8 AM

      Registration and refreshments

      8:50 AM

      Chair’s opening remarks

      9 AM

      ATR Unlocked: Driving Quality Through a Risk-Based Management Lens

      As the landscape of clinical research continues to evolve, the integration of Artificial Intelligence (AI) presents unprecedented opportunities for transforming clinical data management. This presentation will explore how AI is being harnessed to revolutionize solutioning and accelerate clinical trials, focusing on three main areas:

      • Master Data Management: Implementing AI tools to enhance the efficiency, accuracy, and compliance of data handling, driving significant improvements in trial outcomes.
      • Transactional Workflows: Utilizing AI to streamline and optimize clinical trial processes.
      • Agentic Workflows: Leveraging a centralized AI platform to build robust solutions that automate and improve decision-making in clinical research.

      What are the practical challenges, innovative solutions, and the potential return on investment (ROI) that AI brings to clinical data management, as we move from theory to therapy.

      Speakers

      Emma Albacar
      Director, Clinical Data Management (Oncology), AstraZeneca
      Lorena Rodriguez
      Associate Director, Program Data Leader, Alexion Pharmaceuticals

      9:30 AM

      Session reserved for event sponsor

      10 AM

      Best practice for overcoming clinical data management challenges as a small biotech

      Speakers

      Tarik Hicheur
      Data Analytics & Business Intelligence Director, Inotrem
      Mohamed Benabed
      Clinical Trial Leader, Alentis Therapeutics

      10:30 AM

      Session reserved for event sponsor

      11 AM

      Morning refreshments and networking

      11:30 AM

      How to use GenAI to enhance clinical trial data management

      Speakers

      Nilo Paredes
      Strategic Program Lead - Data Fabric, Roche

      12 PM

      Session reserved for event sponsor

      12:30 PM

      How to effectively document and track clinical monitoring activities to enhance data management processes

      Speakers

      Leandro Santos
      Associate Director, Country Operations Management, Alexion Pharmaceuticals

      1 PM

      Technology Spotlight

      1:15 PM

      Lunch and networking

      2:15 PM

      Global Libraries

      Speakers

      Dr. Kavita Gaadhe
      Data Management Lead, ITM Isotope Technologies

      2:45 PM

      Session reserved for event sponsor

      3:15 PM

      Overcoming challenging regulatory environments when implementing AI systems to enhance data management processes

      Speakers

      Reeva Sharma
      Associate Director Quality CSV, Automation, Digitalization and E-systems, Merck

      3:45 PM

      Afternoon refreshments and networking

      4:15 PM

      RadioPharmaceuticals: Understanding the unique specificities of RadioPharm Trials, and the unique challenges for data management

      • Unique Nature of Radiopharmaceuticals in Clinical Trials
      • Strategies for Effective Data Management
      • Operational Challenges in Trial Design & Execution
      • Complexity of Multimodal Data Integration
      • Unique Challenges in Data Management

      Speakers

      Neha Shah
      Manager Clinical Data Management Lead, ITM Isotope Technologies

      4:30 PM

      Session reserved for event sponsor

      5 PM

      Chair’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS

      8 AM

      Registration and refreshments

      8:50 AM

      Chair’s opening remarks

      9 AM

      Interactive Speaker-Hosted Roundtable Discussions

      Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will be led by a table moderator and will focus on a different challenge within oncology clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.
      After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      RT 1 Effectively managing data across multiple sources

      RT 2 Encouraging team collaboration to streamline data management processes

      RT 3 Good clinical practice and clinical data management

      RT 4 Streamlining management processes through enhanced data point selection

      10:30 AM

      Morning refreshments and networking

      10:30 AM

      Assessing vendor capabilities to enhance data management processes

      • Evaluating study plans effectively to strengthen vendor selection and enhance data management strategies
      • Aligning data management goals with vendor capabilities to reduce workload
      • Enhancing vendor selection though effective identification methods

      Speakers

      Suchi Thakur
      Director DM, Local Labs and External Data Operations, AstraZeneca

      11 AM

      Session reserved for event sponsor

      Speakers

      Magali Traskine
      Associate Director, Central Monitoring, GSK

      11:30 AM

      Leveraging AI to increase efficiency and reduce workload

      • Overviewing current AI trends to understand technical capabilities
      • Identifying ways AI can improve data management practices to increase efficiency
      • Incorporating AI effectively to minimize clinical trial timelines when managing data

      Speakers

      Tom Trolez
      Director of Global Data & Analytics Solution Delivery, Novartis

      12 PM

      Adopting a risk-based approach to forecast and mitigate delays

      • Evaluating benefits of a risk-based approach when executing a clinical trial
      • Making data-driven decisions to forecast and minimize impact of risk
      • Integrating RBQM effectively into clinical trial designs to strengthen risk-based approaches

      Speakers

      Mariia Lapaeva
      Senior Data Sciences Product Leader, F. Hoffmann-La Roche AG

      12:30 PM

      Lunch, networking and prize draw

      1:45 PM

      PANEL: The future of data management: Trends, technology and innovation

      • Overviewing current approaches and trends within clinical data management
      • Assessing challenges and identifying solutions
      • Understanding the where the industry is heading to curb competition

      Speakers

      Tom Trolez
      Director of Global Data & Analytics Solution Delivery, Novartis
      Amulya Bondada
      Head of Data Strategy and Framework, Bayer

      2:15 PM

      Session reserved for event sponsor

      Speakers

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

      2:45 PM

      Navigating vendor relationships: Keys to clinical data management success

      Speakers

      Charlotte Preuss Nielsen
      Head of Data Management, Zealand Pharma

      3:15 PM

      Implementing an effective data governance strategy to ensure data quality and compliance

      Speakers

      Amulya Bondada
      Head of Data Strategy and Framework, Bayer

      3:45 PM

      Chair’s closing remarks

      Speakers

      Select a speaker to learn more

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      Leandro Santos
      Associate Director, Country Operations Management, Alexion Pharmaceuticals
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      Lorena Rodriguez
      Associate Director, Program Data Leader, Alexion Pharmaceuticals
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      Emma Albacar
      Director, Clinical Data Management (Oncology), AstraZeneca
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      Suchi Thakur
      Director DM, Local Labs and External Data Operations, AstraZeneca
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      Amulya Bondada
      Head of Data Strategy and Framework, Bayer

      Session Details:

      PANEL: The future of data management: Trends, technology and innovation

      2025-12-04, 1:45 PM

      Session Details:

      Implementing an effective data governance strategy to ensure data quality and compliance

      2025-12-04, 3:15 PM

      View In Agenda
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      Tarik Hicheur
      Data Analytics & Business Intelligence Director, Inotrem
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      Kavita Gaadhe
      Data Management Lead, ITM Isotope Technologies
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      Neha Shah
      Manager Clinical Data Management Lead, ITM Isotope Technologies
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      Tom Trolez
      Director of Global Data & Analytics Solution Delivery, Novartis

      Session Details:

      Leveraging AI to increase efficiency and reduce workload

      2025-12-04, 11:30 AM

      Session Details:

      PANEL: The future of data management: Trends, technology and innovation

      2025-12-04, 1:45 PM

      View In Agenda
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      Reeva Sharma
      Associate Director Quality CSV, Automation, Digitalization and E-systems, Merck

      Session Details:

      Overcoming challenging regulatory environments when implementing AI systems to enhance data management processes

      2025-12-03, 3:15 PM

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      Hanne Aho
      Lead, Excellence Data Management and Programming, Roche
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      Nilo Paredes
      Strategic Program Lead - Data Fabric, Roche
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      Mariia Lapaeva
      Senior Data Sciences Product Leader, Roche
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      Charlotte Preuss Nielsen
      Head of Data Management, Zealand Pharma
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      Plan Your Visit

      Venue

      Hotel Santos Porta Fira, Barcelona Pl. d'Europa, 45, 08908 L'Hospitalet de Llobregat, Barcelona, Spain

      Book Your Stay

      Clinical Data Management Innovation Europe discounted room rate - €140* per night, incl. breakfast

      Use code: CDMI25

      *valid for 1 adult per room

      Accommodation

      Arena International Events Group “(Arena”) is aware of numerous third-party agencies which are contacting Arena’s customers and purporting to have access to hotel room bookings, events attendee lists and selling unsolicited services. It is unclear whether the agencies in question are in possession of such information, or whether they intend to scam unsuspecting customers. Whilst Arena International Events Group pursues such third-party companies for their potentially illicit activity, Arena encourages you to be cautious in engaging with such third-party agencies and Arena shall not accept any responsibility for any losses incurred by you should you choose to engage with third parties that have no affiliation to Arena International Events Group..

      2025 Sponsors

      Select a sponsor to learn more

      Session Sponsors

      Lanyard sponsor

      Exhibitors

      Co Sponsor

      Why partner?

      Contact us to become a partner

      Partnership Opportunities

      We work with you to design a bespoke package to meet your business needs, where you could:

      • Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
      • Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
        Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
      • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

      Event reach

      • 100+ attendees each year
      • 80% attendees C-suite level

       

      Take a look at our current sponsors

      Media Centre

      Become A Media Partner

       A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES

      The programme will feature a range of speakers from the likes of Bristol Myers Squib, Otsuka, Cerevel Therapeutics, Merck, Daiichi Sankyo and many more, who through a variety of interactive session formats will offer insight on promoting successful clinical data management.

      See What It's All About

      Enquiry

      Contact Us

      SPONSORSHIP ENQUIRIES

      Conor Taylor

      Sponsorship Sales Manager

      +44 (0) 20 7936 6870

      SPEAKER ENQUIRIES

      Maya Hudson

      Deputy Head of Production

      +44 204540 7766

      MARKETING ENQUIRIES

      Moona Popal

      Marketing Manager

      DELEGATE ENQUIRIES

      Sunny Saikia

      VIP Delegate Manager

      SPONSORSHIP ENQUIRIES

      To enquire about sponsorship opportunities for the conference, please contact

      Conor Taylor

      Sponsorship Sales Manager


      +44 (0) 20 7936 6870

      SPEAKER ENQUIRES

      To enquire about speaking opportunities for the conference, please contact:

      Maya Hudson

      Deputy Head of Production


      +44 204540 7766