Digital Optimisation of Clinical Trials

Learn to implement decentralised processes (DCT) and digital elements

Date icon

1 - 3 Oct 2025

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On location

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English

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20,000 DKK ex VAT

(app. 2,689 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

SUMMARY


This three-day course introduces you to the state of affairs in implementing digital solutions in clinical trials. It is invaluable to anyone involved with clinical research and trials.


Professionals involved in clinical trials face numerous opportunities in these changing times. But to contribute and create value, it is necessary to understand how you can implement digital solutions in a clinical trial.

At the course, experienced experts from different stages of the value chain in clinical trials share their experiences with e.g. regulatory authorities, patient associations, Decentralised Clinical Trial (DCT) related associations, principal investigators, and both pharmaceutical/biotech and CRO/SAAS providers.

During the course you also have the opportunity to put your new knowledge into use when you participate in group sessions.


Your learning experience

The course takes a novel approach to learning as it is built as a decentralised clinical trial to enhance your practical outcome of the course. You get:

    • Prior to course start you are asked to sign-on to the trial platform and you get a hands-on decentralised trial experience.
    • 3 days of lectures, case-based group assignments, and selected vendor demonstrations. The 3 on-site days are held at Atrium on October 1 - 3, 2024.
    • Between the physical course dates, there will be online sessions (2 x 2 hours) with teaching from experts within the field. More info to follow.

    Other course participants say

    "Focused, relevant, well-planned and well-executed course. Various backgrounds of the attendees contributed to interesting discussions. Good balance between presentations, real-life cases, and case-work."

    Hanne Klenø, MSL



    "The facilitators clearly have experience in the field and are able to facilitate discussions on both the past, current situation, and what might happen in the future. Furthermore the other course participants also engaged in relevant and insightful discussions."

    Mikael Gibson, Senior Trial manager and eClinical specialist, Zealand Pharma A/S



    Keywords

    • Decentralised clinical trials
    • Hybrid clinical trials
    • Vendor selection
    • Patient role in clinical trials
    • Provision of clinical data

    "If you work with designing and executing clinical trials in either biotech, pharma, or a CRO, you must be able to choose wisely when decentralising and using digital health technologies. At this course, world leading experts from the DCT ecosystem enlighten and equip you to select what’s valuable for your organisation."

    - Course leader, Christian Born Djurhuus
    MD, PhD, BSc and Owner Djurhuus-Consulting


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    Course leader & lecturers

    • John Zibert
      Course leader
      CEO
      Future-Brain ApS
    • Morten Lind Jensen
      Course leader
      MD, PhD, DPM, VP of Development, Union Therapeutics
      Union Therapeutics A/S
    • Kai Langel
      Lecturer
      Co-Founder, DEEP
      Janssen, Spain
    • Rajesh Dash
      Lecturer
      Associate Professor of Cardiovascular Medicine
      Stanford University Medical Center
    • Rebecca Jackson
      Lecturer
      Senior Manager, Clinical Innovation R&D IT
      The Janssen Pharmaceutical Companies of Johnson & Johnson
    • Frederik Grell Nørgaard
      Lecturer
      Sektionsleder
      Lægemiddelstyrelsen
    • Kasper Bendix Johnsen
      Lecturer
      Specialkonsulent, Cand.scient.med., ph.d.
      Nationalt Center for Etik
    • Lukasz Bojarski
      Lecturer
      Senior Director Centralized Monitoring
      AstraZeneca Pharma Poland
    • Michelle Birknow
      Lecturer
      Head of Decentralised Clinical Trials Development
      Trial Nation
    • Guillaume Carbonneau
      Lecturer
      VP, Operational Data Insights
      Novo Nordisk A/S
    See all

    Watch the video

    Is this course for you?

    Participate if you are involved in clinical investigations and/or trials either in the clinic, pharmaceutical industry, or as a CRO, and are interested in pursuing adoption of digital tools in a clinical trial.

    What you will learn

    1. What is DCT and the DCT platform? 
    2. Where can DCT and digital data be leveraged to optimise clinical trial planning and conduct?
    3. Opportunities and limitations when using digital health technologies in clinical research.
    4. What do health authorities and ethical committees think?
    5. Hand-on experience with the DCT platform.
    6. DCT tools for subsidiaries as well as headquarter.

    What your company will get

    1. An employee who knows the tools for DCT and is aware of the opportunities and limitations that DCT entails.
    2. An employ who can work with decentralised platforms. 
    3. An employee who is ready to assess potential DCT vendors.
    4. An employee who is aware of ethical and legal challenges.
    5. An employee who can facilitate discussions about opportunities and limitations when using digital health technologies in clinical research.

    Course calendar

    Starting 1 Oct 2025
    Online-session

    One to one course enrollment conversation with course leaders. 

    Date:
    From the beginning of August. Date and time is arranged between the course leader and the course attendee.

    Hands-on practice: Engaging with a DCT platform

    Enroll to the trial platform:

    • ”screening questions”
    • ”informed consent” interview with course responsible
    • ”demographics questionnaire”
    • ”reception of IMP”
    • ”booking of physical site visit” 

      1 Oct 2025 9:00-16:00
      Day 1

      Overview of DCT

      • What is DCT?
      • The DCT platform capabilities.
      • Vendor selection.
      • Opportunity space, decentralisation of patients, recruitment, and diversity.
      • Benefits of DCT-elements for investigators and patients in clinical trials.
        2 Oct 2025 9:00-16:00
        Day 2

        Group work

        1. Design

        Study design, patient involvement, protocol, suitable endpoints. Samples/ measurements. Trial phase and location considerations.

        1. Operational planning

        Challenges with informed consent and digitalisation. Patient and investigator training. IMP supply. Monitoring and reporting of safety. Compliance tracking.

        1. Quality assurance

        Choosing and auditing a DCT platform vendor. Vendor oversight. Data Quality assurance. Data flow (GXP, HIPAA, GDPR) and handling.

        Lecture

        Disruption of the conventional clinical trial industry.

          3 Oct 2025 9:00-16:00
          Day 3

          Leveraging digital date to optimise clinical trial planning

          Optimising clinical trial planning

          • Via existing data or AI
          • Reducing subject numbers via synthetic data and digital twins
          • Using data to select the right CRO and sites
          • Risk based design and monitoring


          DCT thinking by the health authorities and ethics committees

          • Health Authority guideline: perspectives and vision.
          • Ethical considerations.
          • Discussion with EC & DKMA.
            Practical information

            Registration

            Registration deadline
            24 Sep 2025
            Atrium
            Lersø Parkallé 101
            2100 København Ø
            Register
            1 - 3 Oct
            Sometimes things change. This is the expected programme.

            Course information

            Literature

            Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

            Furthermore, you must log-in to the DCT platform for the course where you will be assigned tasks in relation to the course. (See more under “Prerequisites").

            Prerequisites

            You must have some experience with working with clinical trials or clinical investigations.

            Prior to the course, you will be invited to an interview with the course leaders to discuss your current competencies and expectations for the course. You will receive a study kit, and you will be asked to log into the DCT platform and register the study.
            This should be done prior to course start.

            Examination

            There is no examination for this course. However, the final exercise is mandatory participation in the two-day conference, “Outsourcing Clinical Trials”, and discussion of specific assignments in a plenum session. These are requirements for issuing your course certificate.

            Course leaders

            John Zibert
            CEO
            Future-Brain ApS
            Morten Lind Jensen
            MD, PhD, DPM, VP of Development, Union Therapeutics
            Union Therapeutics A/S

            Lecturers

            Kai Langel
            Co-Founder, DEEP
            Janssen, Spain
            Rajesh Dash
            Associate Professor of Cardiovascular Medicine
            Stanford University Medical Center
            Rebecca Jackson
            Senior Manager, Clinical Innovation R&D IT
            The Janssen Pharmaceutical Companies of Johnson & Johnson
            Frederik Grell Nørgaard
            Sektionsleder
            Lægemiddelstyrelsen
            Kasper Bendix Johnsen
            Specialkonsulent, Cand.scient.med., ph.d.
            Nationalt Center for Etik
            Lukasz Bojarski
            Senior Director Centralized Monitoring
            AstraZeneca Pharma Poland
            Michelle Birknow
            Head of Decentralised Clinical Trials Development
            Trial Nation
            Guillaume Carbonneau
            VP, Operational Data Insights
            Novo Nordisk A/S

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            Want to know more or need help?

            Contact Client Manager Christina Spangsberg at +45 39 15 09 22

            Send me a message