11th Annual Clinical Trial Supply Nordics 2023

The annual meeting place for pharmaceutical, biotechnology, and medical device communities in the Nordics to network and discuss strategies for supply chain success in clinical trials

24 - 25

October

2023
  • Clarion Hotel & Congress Copenhagen Airport, Denmark
  • Complimentary
  • Why attend?
  • Agenda
  • Speakers
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  • Sponsors
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Featured Speakers

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Sonia Ben Hamida​

Head of Special Cargo, International Air Transport Association (IATA)

As Head of Special Cargo at the International Air Transport Association (IATA), Dr Sonia Ben Hamida leads the development of the special cargo agenda, delivering standards, business processes, and solutions for the air cargo supply chain related to the transport of live animals, perishables, and temperature-sensitive cargo, and all other special cargo. Prior to joining IATA, Sonia held several roles in France where she spent 8 years driving innovation in the aerospace industry. Then she joined academia in 2019 as a lecturer and researcher at EPFL, the Swiss Federal Institute of Technology in Lausanne, and UNIGE, the University of Geneva. Over the past 12 years, I have built a strong expertise in project management, innovation, design, and business and systems modeling. Sonia holds an engineering degree in Aviation and Computer Science from the French Civil Aviation University - ENAC (France) and a PhD in Innovation from CentraleSupélec (France).

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Linda Collstedt​

Senior Clinical Supply Program Lead, AstraZeneca

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Tanja Villumsen​

Clinical Supply Specialist, Stem Cell R&D, Novo Nordisk

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Stephen Lutsch​

Senior Director Clinical Trial Digital Innovation, Genmab

In my position as Senior Director - Clinical Trial Digital Innovation at Genmab, I lead a team driving AI adoption within clinical operations, decentralized clinical trials and digital innovation in drug development. Previously, I have been working to bring the best disruptive innovation into normal clinical operations at LEO Pharma to help improve and accelerate their clinical trials. Furthermore, I am trying to solve some of the toughest challenges related to scaling digitalization, data, and automation to generate competitive advantages across business units. One aspect is driving the necessary foundational components around a scalable GxP data platform, machine learning opportunities as well as automating digital processes with robotics process automation. Besides leading the necessary change internally, focus is on a design-thinking approach where we put the patient and site at the center. I have an ambition towards “delighting” patients, investigators, and sponsors by solving the real-world challenges they face by leveraging both qualitative interviews and observation, as well as quantitative methods to reveal actionable insights

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Jasmin Hellwig​

Associate Director Vendor Relationship Management, MSD

Jasmin Hellwig graduated from the Applied Institute of Science in Muttenz, Switzerland, 2005 in Chemistry and joined Inovalab AG the same year as Study Director. In her various roles, including Business Development, Deputy of the General Management and Deputy of Test Facility Management, she enjoyed facilitating success by supporting processes, which meet high quality and business need. Since 2010 Jasmin is part of the Global Clinical Supplies department of MSD, former Schering Plough. She started as Project Lead coordinating packaging of clinical supplies and supporting integration projects. In September 2014, Jasmin joined the Comparator Sourcing and Planning group, supporting Clinical Trials by purchasing comparators on time from various sources. Since 2020, she fosters the Relationship Management group.

Besides various hobbies she cultivates, particularly horses and singing, she graduated as MSc in Management from the Lorange Business School, Zurich, Switzerland, in 2015.

 

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    2023 Sponsors Included:

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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

    Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

    Company Website

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

    Clario is a leading provider of endpoint data solutions that generate high-quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints. Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2012.

    Company Website

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

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    Company Information

    Flex Databases platform is a secure, unified and compliant system for clinical trials. Our platform consists of 13 modules that cover every aspect of clinical trials, from project startup to pharmacovigilance. We offer both single modules and a unified solution to maintain all processes – you can cover all existing software needs with only one vendor.

    Company Website

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

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    Company Website

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

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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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    Company Information

    TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

    Company Website

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

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    Company Information

    At Viedoc, we design engaging software that modernizes clinical research so that necessary treatments can reach the people who need them faster. We believe in life and science, in people, and in our collective power to change the world and build a healthier future. That unmatched driving force is what pushes us to innovate, accelerate and improve every aspect of modern clinical studies.

    Company Website

    To learn more, please visit our website - www.viedoc.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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    eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

    Company Website

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

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    Company Information

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    Company Website

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

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    Company Information

    Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

    Company Website

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

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    Company Information

    The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

    Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

    The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

    The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

    To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

    Company Website

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

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    Company Information

    Barrington James are a Global specialist recruitment consul­tancy working across the Healthcare sector.  Our structure, with separate divisions and dedicated consultants for the markets we serve ensures a thorough, professional and intelligent approach in both permanent and interim solutions.  Our tailored methodologies include Contingency database search and executive search.

    Company Website

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

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    Company Information

    Brocacef operates throughout the entire pharmaceutical chain, lending us an unique position as a wholesaler in the Dutch pharmaceutical healthcare industry. With expertise in global logistics, sourcing and supply chain experience Brocacef is able to offer a variety of services for clinical trials.

    Company Website

    To learn more, please visit our website - www.brocacef.nl

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    BSI Life Sciences offers smart eClinical software for CTMS, eTMF and more. BSI makes life science software for people – and has done so for over 25 years. BSI’s software solution is made in Switzerland, Germany, USA and anywhere else clients need to be, and focused on being innovative and user-friendly. They focus on staying ahead of the industry trends and delivering a functional, compliant, and leading edge eClinical solution. This way, BSI helps its customers continuously optimize and accelerate the clinical development process. And that’s what they love! www.bsi-lifesciences.com

    Company Website

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

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    Company Information

    Caidya is a multi-therapeutic clinical research organization (CRO) serving innovators worldwide. Focused on delivery excellence and an elevated customer experience, Caidya offers a wide range of clinical services and vast therapeutic expertise, supporting its partners from pre-IND strategy, through clinical development to submission and post-marketing surveillance. Caidya leverages industry-leading and proprietary clinical technology to ensure trial transparency and data-driven decision-making. Formed in 2021 following the merger of leading CROs, dMed and Clinipace, Caidya has nearly 1,800 employees in 30+ countries throughout the world.

    Company Website

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

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    Company Information

    Clinical ink is the global life science company bringing data, technology, and patient-centric research together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, and digital biomarkers advancements (including use of Continuous Glucose Monitoring for detection of hypoglycemia), support the next generation of clinical trials and ultimately the clinical management of patients.

    Company Website

    To learn more, please visit our website - https://url.uk.m.mimecastprotect.com/s/PEWUCjY26Sx7YvltWfYImAmLe?domain=clinicalink.com/

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    Company Information

    A world leader in the design and manufacture of high-performance temperature-controlled packaging systems for the transport of pharmaceutical products, EMBALL’ISO is now an expert of turnkey Reuse, Reverse Logistics and Rental solutions. 

    EMBALL’ISO’s worldwide presence across 4 continents, with 8 production sites (Brazil, China, France, Germany, India, Singapore, UK and the US), 14 Services Centre and collection points in more than 80 countries helps you reuse isothermal packaging while saving time and money. 

    We supply systems capable of carrying a single vial to airfreight pallet shippers available flat packed or fully assembled in new and innovative Logistics Business models. 

    EMBALL’ISO delivers quality everywhere, just like you.

    Company Website

    To learn more, please visit our website - www.emballiso.com/en/

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      Why attend?

      This is the unmissable event that the pharmaceutical, biotechnology, and medical device communities need to come together and discuss strategies for operational success in clinical trials. Combining our OCT, CTS and Medical Devices events, this is the perfect platform for professionals from across a range of clinical trial functions to meet, network, and hear about latest developments.

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      WHAT TO EXPECT FOR 2023?

      200+

      Attendees

      		30+

      Exhibitors

      		30+

      Speakers
      200+

      Attendees

      		30+

      Exhibitors
      30+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 24 Oct 2023
      • 25 Oct 2023
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      Streams

      Stream one

      CLINICAL TRIAL SUPPLY

      7:30 AM

      Registration and refreshments

      8:15 AM

      Chairperson’s opening remarks

      Speakers

      Catherine Longworth
      Editor in Chief, Healthcare, GlobalData

      8:30 AM

      Choosing the right CMO and making it your partner to manufacture your product

      • Importance of a network design to act strategically and not tactically
      • Considerations when selecting your CMO, what can jeopardize the relationship and to be considered at selection
      • Defining clear expectations to maximise and harmonise relationships between sponsor and CMO: how to turn business relation into partnership

      Speakers

      Pierre-Gaultier Delheid
      Head of Clinical Vendor Management, UCB Pharma

      9 AM

      Real-world AI in IRT: From ChatGPT to Large Language Models

      The integration of AI into Interactive Response Technology (IRT) has become more than a trend; it's a transformational shift that’s reshaping patient randomization and trial supply management.

      • Crawl - Introduction to AI in IRT:
      • ChatGPT in Action: Explore the initial steps of AI integration, using ChatGPT to aid in writing specifications and supply predictions
      • Demystifying LLMs: An introductory overview of Large Language Models and their potential in IRT
      • Walk - Advanced Techniques with ChatGPT Plus:
      • Templates and Automation: Learn how to utilize templates in ChatGPT, streamline repetitive tasks and enhance efficiency
      • Run - Next-Level AI Integration:
      • Advanced Applications: Delve into more complex use cases, exploring how advanced AI models can further optimize IRT processes
      • Security, Data Strategy, and UX: Address essential technical considerations for success
      • Fly - Enterprise Adoption of LLMs:
      • Preparing Your Organization: Strategies to equip your organization for the full-scale adoption of LLMs in the context of IRT/RTSM
      • Future Roadmaps: Explore potential and strategic roadmaps for LLMs within the industry

      Speakers

      Bryan Clayton
      Chief Commercial Officer, Endpoint Clinical

      9:30 AM

      Sharing updates to IATA Temperature Control Regulations and best practice for temperature-controlled airfreight global logistics for clinical trials

      • Providing an update on latest changes to IATA Temperature Control Regulations
      • Discussing Time and Temperature Sensitive labelling and packaging
      • Reviewing the acceptance checklist for time sensitive shipments
      • Highlighting best practice and lessons learned for the sponsor perspective

      Speakers

      Sonia Ben Hamida
      Head of Special Cargo, International Air Transport Association (IATA)

      10 AM

      Tackling Trial Supply Shortages with Advanced RTSM/IRT

      Medication supply shortages have become a widespread industry concern. Good RTSM/IRT design can prevent shortages from jeopardizing clinical trial study goals.

      In this session we will cover how a robust interactive response technology (IRT) system can address drug supply issues and outline the actions that can be taken to manage both expected and emergency drug shortages.

      • Planning – supply simulation can assist with planning manufacturing campaigns and optimal supply chains, especially if supplies are limited
      • Designing – advanced supply management options can ensure the challenge of limited stock is prioritized
      • Adapting – RTSM settings can be quickly adapted to manage unforeseen situations during trial execution, such as delayed batch manufacture

      Speakers

      Patricia Rayner
      Associate Director, Project & Program Management, CALYX

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Patient centricity: a supply chain perspective

      • Looking at patient centricity from an internal and external label and packaging perspective
      • Considerations for supply chain and patient centricity
      • Handling challenges and highlighting success factors

      Speakers

      Jasmin Hellwig
      Associate Director Vendor Relationship Management, MSD

      11:30 AM

      Optimizing Trial Success with RTSM Resupply Strategies for Seamless Supply Continuity

      The trend to personalized treatments drives more and more complex drug combination research with approved commercial standard of care drugs. The need for expensive co-medication and comparator supplies is continuously increasing and with global commercial drug supply shortages, the sponsors are more and more challenged to design the supply chain effectively to ensure supplies while managing supply shortages and minimizing scrap.

      As a critical system ensuring supply within clinical trials, RTSM resupply considerations and capabilities ensure correct supply continuity in trials. Protocol designs dictates the requirements for investigational drug, co-medication and comparator demand to properly assess the efficacy of a new medicinal product. As such, the proper provisioning of all study drugs requires supply oversight and management of costly product.

      Please join a panel discussion featuring 4G Clinical and Inceptua as they discuss trends and challenges in supply management of these distinct but not dissimilar supply chains. Topics will include:

      • Challenges in site resupply logic facing supply teams as clinical trials evolve
      • Blinding considerations for sites with low enrollment considerations
      • Methodology underlying the definition and maintenance of trigger and buffer resupply values
      • Comparing short term inventory management system (RTSM) and long-term solutions (Demand & Supply solutions) and their criticality to success

      Speakers

      Libbi Rickenbacher
      Senior Director Product Strategy and Partnerships, 4G Clinical
      Benjamin Etschmann
      Senior Forecasting Services Lead, 4G Clinical,
      Jan Pieter Kappelle
      VP of Clinical Services at Inceptua

      12 PM

      Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

      • Future supply chain considerations since the impact of challenges provoked by regulatory changes, Covid-19, Brexit and the Russia-Ukraine conflict
      • Improving supply chain sourcing and waste reduction
      • Opportunities to enhance supply chain and processes through data driven technologies

      Speakers

      Pernille Hemmingsen
      Chief Technology Officer, Adcendo
      Julian De Garcia
      Head of Development and Clinical Planning, UCB
      Catherine Longworth
      Editor in Chief, Healthcare, GlobalData

      12:30 PM

      Accelerated performance of complex exploratory patient studies: Practical insights from investigational site

      • Global Challenges & Industry Trends
      • Research Clinics dedicated to early patient trials
      • Key elements to consider when planning a phase IB/IIA Patient Trial
      • Case Studies

      Speakers

      Dr. Claudia Hesselmann
      Founder & CEO, ARENSIA Exploratory Medicine

      1 PM

      Lunch and networking

      2 PM

      Considerations for setting up trial supplies for stem cell based advanced therapy medicinal products

      • Differences between ATIMPS and conventional trial supplies
      • Complying with labelling regulations
      • Services and equipment considerations for ultra cold supply chain

      Speakers

      Tanja Villumsen
      Clinical Supply Specialist, Stem Cell R&D, Novo Nordisk
      Sofie Dalsgaard Seiersen
      Clinical Supply Coordinator Cell Therapy, Novo Nordisk

      2:30 PM

      Considering disruption and uncertainty when forecasting in supply chain to pre-plan effectively

      • Creating your forecasting and demand planning strategy with uncertainty in mind
      • Ensuring budget flexibility to overcome unexpected disruptions
      • Communicating with your clinical operations team for demand planning regarding uncertainty of patient enrolment
      • Considering technology to assist with forecasting and demand planning

      Speakers

      Linda Collstedt
      Senior Clinical Supply Program Lead, AstraZeneca

      3 PM

      Afternoon refreshments and networking

      3:30 PM

      Panel Discussion: Enhancing supply chain relationships with internal teams and external vendors to improve supply chain efficiency

      • Considerations between clinical operations and clinical supply to ensure study success
      • Working closely with the regulatory team to understand roadmaps and overcome challenges
      • Collaborating effectively with vendors to improve communications and oversight

      Speakers

      Catherine Longworth
      Editor in Chief, Healthcare, GlobalData
      Jasmin Hellwig
      Associate Director Vendor Relationship Management, MSD
      Linda Collstedt
      Senior Clinical Supply Program Lead, AstraZeneca

      4 PM

      Seamless Digital Collaboration: Uniting Vendors and Sponsors via eSystems for Transparency and Compliance

      • Real-life practice: scenarios with multiple stakeholders – CROs, sponsors, inspectors, and vendors – access, roles, compliance
      • Digital Collaboration: communication obstacles, fragmented workflows and data discrepancies among vendors, sponsors, and eSystems
      • Demonstrating compliance: digital tools to meet industry regulations and standards
      • Transparency: establishing trust, accountability, and fostering effective collaboration
      • Adaptability: modern eSystems should integrate for smoother collaboration and efficiency

      Speakers

      Evgenia Michalcuk-Vrablik
      Global Director of Growth, Flex Databases

      4:30 PM

      Planning and executing clinical trial supply lifecycle from a small biopharma perspective

      • Efficient use of available IMP considering study design, shipment, labelling, stability
      • Updates during study for stability, impact on labelling, shipment etc.
      • QP release, shipment to sites, including differences between US and EU
      • Preparation and administration considering regulations and available in-use study data

      Speakers

      Susan Suchdev
      Chief Operating Officer, Annexin Pharmaceuticals

      5 PM

      Chairperson’s closing remarks

      Speakers

      Catherine Longworth
      Editor in Chief, Healthcare, GlobalData

      END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY FORTREA

      Streams

      Stream one

      CLINICAL TRIALS TECHNOLOGY & INNOVATION

      8:15 AM

      Registration and Refreshments

      8:45 AM

      Chairperson’s Opening Remarks

      Speakers

      Catherine Longworth
      Editor in Chief, Healthcare, GlobalData

      9 AM

      Evolving use of AI and Big Data clinical trials to streamline processes and reduce costs

      • Identifying risks and rewards
      • Reviewing cost savings through use of AI and big data
      • Evaluating benefits of using automation and ML technologies to enhance conduction and management of trials
      • Highlighting successes of implementing AI and machine learning tools through case study examples

      Speakers

      Stephen Lutsch
      Senior Director Clinical Trial Digital Innovation, Genmab

      9:30 AM

      Digitalization in clinical trials, a 360 view

      • Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
      • Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
      • Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
      • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more
      • Major points to consider in designing digital trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind

      Speakers

      Sverre Bengtsson
      Co-Founder, Viedoc

      10 AM

      Implementing digital health technologies into clinical trials

      • What is Digital Health?
      • How can Digital Health Technologies be used in Clinical Development?
      • Challenges and opportunities
      • Process for selection and implementation

      Speakers

      Viktorija Terebaite
      Head of Digital Health Technologies, Lundbeck

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Utilising blockchain technology to improve digital supply chain

      • Highlighting benefits of blockchain technology to increase visibility and efficiency in supply chain
      • Considering risks and challenges of blockchain
      • Sharing successes and lessons learnt

      Speakers

      Alexandru Popa
      Associate Director, Blockchain for Digital Supply Chain, MSD

      11:30 AM

      Exploring data management tools and technologies that can assist throughout end-to-end clinical trials

      • Discussing technologies and tools available for each stage of the clinical trial
      • Outlining the risks and rewards of data management tools and technologies
      • Providing case study examples of successes and lessons learnt

      Speakers

      12 PM

      Lunch and networking

      1 PM

      Fireside Chat: Innovation in clinical trials – a sanity check

      Participants who have completed the ATRIUM CPH course “Driving Decentralised Clinical Trials” will discuss their thoughts on decentralising and using digital health technologies in clinical development. Which direction are they setting for their organisations, and how will they work with investigators, regulators and vendors moving forward.

      Speakers

      John Zibert
      Chief Medical Officer, Coegin Pharma AB
      Morten Lind Jensen
      VP Of Medical Science, UNION Therapeutics
      Christian Born Djurhuus
      MD PhD

      1:30 PM

      Virtual clinical trials and medical devices

      • What are they
      • Advantages
      • Recent Trends
      • Likely future trends

      Speakers

      Andrew Thompson
      Director of Therapy Research & Analysis, Medical Devices, GlobalData

      2 PM

      Afternoon refreshments, networking and prize draw

      2:30 PM

      ROUNDTABLE SESSIONS

      During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      Roundtable 1
      Overcoming challenges in clinical supply resourcing
      Pernille Hemmingsen, Chief Technology Officer, Adcendo

      Roundtable 2
      Discussing the role and inclusion of patient relatives in trial reporting and data
      Christoffer Johansen, Head, CASTLE - Cancer Late Effect Research, Center for Surgery and Cancer,
      Rigshospitalet

      Roundtable 3
      Considering how to make your clinical trials more environmental and social sustainable
      Anna Arnsvik, ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

      Speakers

      Pernille Hemmingsen
      Chief Technology Officer, Adcendo
      Christoffer Johansen
      Head, CASTLE - Cancer Late Effect Research, Center for Surgery and Cancer, Rigshospitalet
      Anna Arnsvik
      ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

      4 PM

      Chairperson’s closing remarks

      Speakers

      Speakers

      Select a speaker to learn more

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      Sonia Ben Hamida
      Head of Special Cargo, International Air Transport Association (IATA)

      As Head of Special Cargo at the International Air Transport Association (IATA), Dr Sonia Ben Hamida leads the development of the special cargo agenda, delivering standards, business processes, and solutions for the air cargo supply chain related to the transport of live animals, perishables, and temperature-sensitive cargo, and all other special cargo. Prior to joining IATA, Sonia held several roles in France where she spent 8 years driving innovation in the aerospace industry. Then she joined academia in 2019 as a lecturer and researcher at EPFL, the Swiss Federal Institute of Technology in Lausanne, and UNIGE, the University of Geneva. Over the past 12 years, I have built a strong expertise in project management, innovation, design, and business and systems modeling. Sonia holds an engineering degree in Aviation and Computer Science from the French Civil Aviation University - ENAC (France) and a PhD in Innovation from CentraleSupélec (France).

      Session Details:

      Sharing updates to IATA Temperature Control Regulations and best practice for temperature-controlled airfreight global logistics for clinical trials

      2023-10-24, 9:30 AM

      View In Agenda

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      Pierre-Gaultier Delheid
      Head of Clinical Vendor Management, UCB Pharma

      As Head of Clinical Vendor Management at UCB, Pierre-Gaultier Delheid leads the vendor strategy aiming to design and manage a strong external vendor network. He makes a point of honor to build sustainable and strong alliances to overcome clinical challenges in a flexibility, agile, reliable, green and cost-efficient way. In close collaboration with other UCB business units, he drives a culture of partnership to change the game to a better outcome.

      Engineer by background, his experience in bio-pharma industry in CDMO as well as in Sponsor companies and his business DNA gained during an international EMBA (Hult, US/UK) led him to build strong expertise in the field of operation and business optimization as well as building strong partnerships.

      Session Details:

      Choosing the right CMO and making it your partner to manufacture your product

      2023-10-24, 8:30 AM

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      Pernille Hemmingsen
      Chief Technology Officer, Adcendo

      Pernille Hemmingsen has more than a decade of experience in the development of pharmaceutical products. With a background in biophysical chemistry and chemical engineering, she is particularly interested in the development of robust manufacturing methods and solid quality to enable the best patient experience and convenience. This interest has led to the development of products ranging from cancer targeting liposomes and antibody drug conjugates to tamper resistant tablets and enhanced diabetes formulations at companies including Genmab and Novo Nordisk. Currently, Pernille Hemmingsen is responsible for the chemistry, manufacturing and control at Adcendo, taking to role as CTO. This work particularly includes establishing an efficient supply chain that encompasses elements from both biologics and small molecules. Pernille holds a Ph.D. from the Department of Chemistry at the Technical University of Denmark and an executive Master of Business Administration from Copenhagen Business School.

      Session Details:

      Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

      2023-10-24, 12:00 PM

      Session Details:

      ROUNDTABLE SESSIONS

      2023-10-25, 2:30 PM

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      Tanja Villumsen
      Clinical Supply Specialist, Stem Cell R&D, Novo Nordisk

      Session Details:

      Considerations for setting up trial supplies for stem cell based advanced therapy medicinal products

      2023-10-24, 2:00 PM

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      Jasmin Hellwig
      Associate Director Vendor Relationship Management, MSD

      Jasmin Hellwig graduated from the Applied Institute of Science in Muttenz, Switzerland, 2005 in Chemistry and joined Inovalab AG the same year as Study Director. In her various roles, including Business Development, Deputy of the General Management and Deputy of Test Facility Management, she enjoyed facilitating success by supporting processes, which meet high quality and business need. Since 2010 Jasmin is part of the Global Clinical Supplies department of MSD, former Schering Plough. She started as Project Lead coordinating packaging of clinical supplies and supporting integration projects. In September 2014, Jasmin joined the Comparator Sourcing and Planning group, supporting Clinical Trials by purchasing comparators on time from various sources. Since 2020, she fosters the Relationship Management group.

      Besides various hobbies she cultivates, particularly horses and singing, she graduated as MSc in Management from the Lorange Business School, Zurich, Switzerland, in 2015.

       

      Session Details:

      Patient centricity: a supply chain perspective

      2023-10-24, 11:00 AM

      Session Details:

      Panel Discussion: Enhancing supply chain relationships with internal teams and external vendors to improve supply chain efficiency

      2023-10-24, 3:30 PM

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      Stephen Lutsch
      Senior Director Clinical Trial Digital Innovation, Genmab

      In my position as Senior Director - Clinical Trial Digital Innovation at Genmab, I lead a team driving AI adoption within clinical operations, decentralized clinical trials and digital innovation in drug development. Previously, I have been working to bring the best disruptive innovation into normal clinical operations at LEO Pharma to help improve and accelerate their clinical trials. Furthermore, I am trying to solve some of the toughest challenges related to scaling digitalization, data, and automation to generate competitive advantages across business units. One aspect is driving the necessary foundational components around a scalable GxP data platform, machine learning opportunities as well as automating digital processes with robotics process automation. Besides leading the necessary change internally, focus is on a design-thinking approach where we put the patient and site at the center. I have an ambition towards “delighting” patients, investigators, and sponsors by solving the real-world challenges they face by leveraging both qualitative interviews and observation, as well as quantitative methods to reveal actionable insights

      Session Details:

      Evolving use of AI and Big Data clinical trials to streamline processes and reduce costs

      2023-10-25, 9:00 AM

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      Session Details:

      Exploring data management tools and technologies that can assist throughout end-to-end clinical trials

      2023-10-25, 11:30 AM

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      Andrew Thompson
      Director of Therapy Research & Analysis, Medical Devices, GlobalData

      Andrew Thompson is the Director of Therapy and Analysis at GlobalData Healthcare, responsible for data collection and forecasting within the Medical Devices portfolio. Andrew is passionate about developing innovative approaches to the world of medical devices industry research. Andrew joined the team in 2012, following 20 years working within the academic and industry sectors, developing a specialty in advanced diagnostics for infectious disease. With multiple patents in molecular detection technologies, publications’ covering a breadth of topics and leading product development teams, Andrew has established a strong reputation within molecular diagnostics. Having worked on the frontline, Andrew can share a global understanding of the medical device industry, with both a highly developed understanding of the technologies, new and emerging, and of the business dynamics fueling medical device usage in healthcare.

      Responsible for the content and direction of global medical device portfolios, GlobalData forward-looking approach generates stimulating analysis and reports, to explore what these changes mean for GlobalData’s clients and their customers.

      Session Details:

      Virtual clinical trials and medical devices

      2023-10-25, 1:30 PM

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      John Zibert
      Chief Medical Officer, Coegin Pharma

      Dr. John Zibert, Chief Medical Officer Coegin Pharma AB, a listed Nordic biotech company with several unique molecular technologies and compounds , where he also serves as CEO of Avexxin Oncology AS and Board Member of Reccura Therapeutics AS. He received his master's in medicine and human biology, and PhD in immunology at the University of Copenhagen, DK and University of Otago, NZ. He has demonstrated a successful history of working in the pharmaceutical and digital healthcare industry in established corporate businesses, and in an incubator co-establishing more than 25 start-ups within digital health and biotech, and several of his own biotech companies. Furthermore, he has an academic footprint of 79 publications in particular within digital health, tumor biology and dermatology. He has a deep experience within execution of drug research and development, Decentralized Clinical Trials, digital healthcare solutions, and leadership.

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      Morten Lind Jensen
      VP Of Medical Science, UNION Therapeutics

      Morten Lind Jensen is VP of Medical Science at UNION Therapeutics A/S. Prior to working at UNION, Morten has 9 years of experience as medical specialist, project manager and line manager from Novo Nordisk, where he worked across the internal Novo Nordisk portfolio and established external collaboration projects within new ways of doing clinical trials and using digital data.

      Prior to joining the pharmaceutical industry, Morten did his Ph.D. within the research space of medical education, and on how to optimize learning outcomes during the training of professionals. He has also worked clinically as a medical doctor within radiology and surgery.

      Morten is an MD from University of Copenhagen, Denmark.

      Session Details:

      Fireside Chat: Innovation in clinical trials – a sanity check

      2023-10-25, 1:00 PM

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      Viktorija Terebaite
      Head of Digital Health Technologies, Lundbeck

      Viktorija Terebaite is professional in the field of Digital Health, boasting four years of direct experience in integrating digital tools into clinical trials and heading Digital Health Technologies team in Lundbeck. Viktorija has a unique perspective on digital health innovation, having been involved not just in the academic and clinical realms, but also in the commercial technology sector where she worked on a development of a software product used by over 60 million people globally.

      Session Details:

      Implementing digital health technologies into clinical trials

      2023-10-25, 10:00 AM

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      Christoffer Johansen
      Head, CASTLE - Cancer Late Effect Research, Center for Surgery and Cancer, Rigshospitalet

      Session Details:

      ROUNDTABLE SESSIONS

      2023-10-25, 2:30 PM

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      Alexandru Popa
      Associate Director, Blockchain for Digital Supply Chain, MSD

      Session Details:

      Utilising blockchain technology to improve digital supply chain

      2023-10-25, 11:00 AM

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      Linda Collstedt
      Senior Clinical Supply Program Lead, AstraZeneca

      Session Details:

      Considering disruption and uncertainty when forecasting in supply chain to pre-plan effectively

      2023-10-24, 2:30 PM

      Session Details:

      Panel Discussion: Enhancing supply chain relationships with internal teams and external vendors to improve supply chain efficiency

      2023-10-24, 3:30 PM

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      Susan Suchdev
      Chief Operating Officer, Annexin Pharmaceuticals

      Session Details:

      Planning and executing clinical trial supply lifecycle from a small biopharma perspective

      2023-10-24, 4:30 PM

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      Catherine Longworth
      Editor in Chief, Healthcare, GlobalData

      Catherine Longworth is the Editor-in-Chief of four flagship healthcare publications at GlobalData, where she leads editorial strategy and content development across the medical devices, pharmaceuticals, and biotechnology sectors. With over a decade of international experience in healthcare journalism and a background in biomedical science, Catherine oversees a team of journalists dedicated to delivering data-driven, high-impact content for a global professional audience.

      Session Details:

      Chairperson’s Opening Remarks

      2023-10-25, 8:45 AM

      Session Details:

      Chairperson’s closing remarks

      2023-10-24, 5:00 PM

      Session Details:

      Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

      2023-10-24, 12:00 PM

      Session Details:

      Chairperson’s opening remarks

      2023-10-24, 8:15 AM

      Session Details:

      Panel Discussion: Enhancing supply chain relationships with internal teams and external vendors to improve supply chain efficiency

      2023-10-24, 3:30 PM

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      Julian De Garcia
      Head of Development and Clinical Planning, UCB

      Session Details:

      Panel Discussion: Overcoming recent challenges, uncovering latest trends and driving innovation in clinical trials

      2023-10-24, 12:00 PM

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      Bryan Clayton
      Chief Commercial Officer, Endpoint Clinical

      Bryan Clayton is a seasoned global commercial leader with experience across multiple functions including sales and marketing, operations, and software product design. For over 20 years, he has effectively managed cross-functional teams, created new technology solutions, managed contract negotiations, and driven revenue growth for top life sciences technology and solutions providers. Bryan is a sought-after speaker, writer and contributor to industry events and publications, and possesses a range of skills well-suited to boost commercial success and revenue growth.

      Bryan joined endpoint Clinical in 2023 as Chief Commercial Officer to lead commercial strategy and business development operations, and to further strengthen endpoint’s expertise in providing agile, patient centric IRT solutions. In his spare time, Bryan coaching and playing baseball.

      Session Details:

      Real-world AI in IRT: From ChatGPT to Large Language Models

      2023-10-24, 9:00 AM

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      Christian Born Djurhuus
      MD PhD

      Session Details:

      Fireside Chat: Innovation in clinical trials – a sanity check

      2023-10-25, 1:00 PM

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      Sofie Dalsgaard Seiersen
      Clinical Supply Coordinator Cell Therapy, Novo Nordisk

      Session Details:

      Considerations for setting up trial supplies for stem cell based advanced therapy medicinal products

      2023-10-24, 2:00 PM

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      Dr. Claudia Hesselmann
      Founder & CEO, ARENSIA Exploratory Medicine

      Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

       

      Session Details:

      Accelerated performance of complex exploratory patient studies: Practical insights from investigational site

      2023-10-24, 12:30 PM

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      Libbi Rickenbacher
      Senior Director Product Strategy and Partnerships, 4G Clinical

      As Senior Director of Product Strategy & Partnerships, Libbi plays a pivotal role in steering 4G’s success by overseeing two critical domains: product strategy and partnerships management. Within the realm of product strategy, Libbi is dedicated to ensuring that 4G’s product portfolio not only meets but exceeds customer expectations while remaining at the forefront of dynamic market trends. In addition, staying close to market trends allows for Libbi to engage and forge impactful partnerships with organisations that align harmoniously with our business objectives.

      Session Details:

      Optimizing Trial Success with RTSM Resupply Strategies for Seamless Supply Continuity

      2023-10-24, 11:30 AM

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      Benjamin Etschmann
      Senior Forecasting Services Lead, 4G Clinical,

      Benjamin has spent more than 10 years in clinical trial supply management in various roles, including operational trial supply logistics management and trial supply setup management. However, his primary focus has been in IVRS/IRT/RTSM management and demand forecasting using dedicated stochastic simulation tools. In his current role, he consults clients and internal teams on probabilistic site and depot demand forecasting in IVRS/IRT/RTSM.

      Session Details:

      Optimizing Trial Success with RTSM Resupply Strategies for Seamless Supply Continuity

      2023-10-24, 11:30 AM

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      Jan Pieter Kappelle
      VP of Clinical Services at Inceptua

      Jan Pieter (JP) Kappelle, VP of Clinical Services at Inceptua, is a Supply Chain Executive with 30 years of industry experience, of which 15 years were spent leading clinical trial supplies departments in global pharmaceutical and biotech companies.

      Trained as an Electronic and Quality Engineer, JP has a strong financial background and brings a methodical, analytical and process-oriented approach to his work. Coupled with his MBA and MSc in Supply Chain Management, JP has the unique ability to switch between strategic and operational discussions.

      JP also serves as the Global Clinical Supplies Group (GCSG) Master of Ceremony where he connects clinical supply professionals for the purposes of education,
      knowledge sharing and the development of industry best practices.

       

      Session Details:

      Optimizing Trial Success with RTSM Resupply Strategies for Seamless Supply Continuity

      2023-10-24, 11:30 AM

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      Anna Arnsvik
      ESG Sustainability Lead and Nordic Head Neuroscience, Novartis

      Anna Arnsvik, an ESG Sustainability Lead, boasts a three-decade life science career within company as Novartis, UCB and Kabi-Pharmacia. Her fusion of innovation and sustainable business strategies has helped her to become an international certified ESG ISB® Advisor. Anna's influence extends to roles in the JUC Sustainability and ESG network, MIAN Minds AB, and various volunteering endeavors

      Session Details:

      ROUNDTABLE SESSIONS

      2023-10-25, 2:30 PM

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      Patricia Rayner
      Associate Director, Project & Program Management, CALYX

      Trish has spent over 14 years helping sponsors to effectively manage their clinical trials and programs with RTSM/IRT solutions & services. She currently holds a leadership role, managing and mentoring a team of RTSM designers. Her focus is on cultivating relationships with clinical trial teams and always on improving the lives of patients.

      Session Details:

      Tackling Trial Supply Shortages with Advanced RTSM/IRT

      2023-10-24, 10:00 AM

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      Evgenia Michalcuk-Vrablik
      Global Director of Growth, Flex Databases

      Evgenia holds several degrees in International Economics and MBA in Digital Transformation, she is in top management of eSystem provider Flex Databases, one of the leading European software providers for Life Sciences.

      She has been in clinical research for 15+ years, 8 years in the company management, participated in digitalization of 60+ companies 15 to 50 000 employees in the US, Europe, and Asia.

      Session Details:

      Seamless Digital Collaboration: Uniting Vendors and Sponsors via eSystems for Transparency and Compliance

      2023-10-24, 4:00 PM

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      Sverre Bengtsson
      Co-Founder, Viedoc

      Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

      Session Details:

      Digitalization in clinical trials, a 360 view

      2023-10-25, 9:30 AM

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