Driving Decentralised Clinical Trials

29 Aug, 19 Sep, 3 Oct, 24 Oct 2023

On location

English

17,640 DKK ex VAT

(app. 2,372 EUR ex VAT)

Early Bird! Sign-up on 1 March 2023 at the latest to benefit from a reduced price. After 1 March 2023 the price is 19,600 DKK.

 

SUMMARY

This four-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 29 August, 19 September, and 3 October 2023.
    • Hands-on exercise in DCT vendor assessment when participating in “OCT Nordics” (24-25 October 2023).

    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(s) & Lecturer(s)

    • John Zibert
      Course leader
      CEO
      Future-Brain ApS
    • Morten Lind Jensen
      Course leader
      MD, PhD, DPM, VP of Medical Science, Union Therapeutics
      Union Therapeutics
    • Christian Born Djurhuus
      Course leader
      MD, PhD, BS and Owner
      Djurhuus-Consulting
    • Kasper Bendix Johnsen
      Lecturer
      Akademisk medarbejder i De Videnskabsetiske Medicinske Komitéer
      Sundhedsministeriet
    • Paul Simms
      Lecturer
      Cheif Executive
      Impatient Health
    • Frederik Grell Nørgaard
      Lecturer
      Special Adviser, Clinical Trials
      Lægemiddelstyrelsen
    • Rajesh Dash
      Lecturer
      Cardiologist
      Atrium
    See all

    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 29 Aug 2023

    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 atendee.

    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”

      29 Aug 2023 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.
        19 Sep 2023 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 2023 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.
            24 Oct 2023 8:00-17:00
            DAY 4

            Hands-on practice: engaging with potential DCT vendors

            • Participate in OCT Nordics (free, complimentary of OCT Nordics).
            • Assignment: interview and select vendors following the course learnings.
            • Physical meet-up with course participants to recap course and discuss learning and outcomes.

            Handing out of course certificate

              Practical information

              Registration

              Registration deadline
              5 Sep 2023
              Atrium
              Lersø Parkallé 101
              2100 København Ø
              Register
              29 Aug - 24 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 leader(s)

              John Zibert
              CEO
              Future-Brain ApS
              Morten Lind Jensen
              MD, PhD, DPM, VP of Medical Science, Union Therapeutics
              Union Therapeutics
              Christian Born Djurhuus
              MD, PhD, BS and Owner
              Djurhuus-Consulting

              Lecturer(s)

              Kasper Bendix Johnsen
              Akademisk medarbejder i De Videnskabsetiske Medicinske Komitéer
              Sundhedsministeriet
              Paul Simms
              Cheif Executive
              Impatient Health
              Frederik Grell Nørgaard
              Special Adviser, Clinical Trials
              Lægemiddelstyrelsen
              Rajesh Dash
              Cardiologist
              Atrium

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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