Driving Decentralised Clinical Trials

Learn how to implement decentralised elements in clinical trials and to leverage digitalisation for clinical research

No available dates

On location

English

6,533 DKK ex VAT

(app. 878 EUR ex VAT)

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 & lecturers

    • John Zibert
      Course leader
      CEO
      Future-Brain ApS
    • Morten Lind Jensen
      Course leader
      MD, PhD, DPM, VP of Medical Science, Union Therapeutics
      Union Therapeutics A/S
    • Christian Born Djurhuus
      Course leader
      MD, PhD, BS and Owner
      Djurhuus-Consulting
    • Frederik Grell Nørgaard
      Lecturer
      Special Adviser, Clinical Trials
      Lægemiddelstyrelsen
    • Ditte Zerlang Christensen
      Lecturer
      EU Project Manager
      Danish Medicines Agency
    • Kasper Bendix Johnsen
      Lecturer
      Specialkonsulent, Cand.scient.med., ph.d.
      Nationalt Center for Etik
    • Guillaume Carbonneau
      Lecturer
      Health Data Insights & Design Head
      Novartis Pharma AG
    • Kai Langel
      Lecturer
      Co-Founder, DEEP (Digital Evidence Ecosystem and Protocols), Sr. Director, Strategy and Innovation, Janssen Global Regulatory Policy
      Janssen, Spain
    • Lukasz Bojarski
      Lecturer
      Senior Director Centralized Monitoring
      AstraZeneca Pharma Poland
    • Rebecca Jackson
      Lecturer
      Senior Manager, Clinical Innovation R&D IT
      The Janssen Pharmaceutical Companies of Johnson & Johnson
    • Rajesh Dash
      Lecturer
      Associate Professor of Cardiovascular Medicine
      Stanford University Medical Center
    • Michelle Birknow
      Lecturer
      Head of Decentralised Clinical Trials Development
      Trial Nation
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    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 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 Medical Science, Union Therapeutics
    Union Therapeutics A/S
    Christian Born Djurhuus
    MD, PhD, BS and Owner
    Djurhuus-Consulting

    Lecturers

    Frederik Grell Nørgaard
    Special Adviser, Clinical Trials
    Lægemiddelstyrelsen
    Ditte Zerlang Christensen
    EU Project Manager
    Danish Medicines Agency
    Kasper Bendix Johnsen
    Specialkonsulent, Cand.scient.med., ph.d.
    Nationalt Center for Etik
    Guillaume Carbonneau
    Health Data Insights & Design Head
    Novartis Pharma AG
    Kai Langel
    Co-Founder, DEEP (Digital Evidence Ecosystem and Protocols), Sr. Director, Strategy and Innovation, Janssen Global Regulatory Policy
    Janssen, Spain
    Lukasz Bojarski
    Senior Director Centralized Monitoring
    AstraZeneca Pharma Poland
    Rebecca Jackson
    Senior Manager, Clinical Innovation R&D IT
    The Janssen Pharmaceutical Companies of Johnson & Johnson
    Rajesh Dash
    Associate Professor of Cardiovascular Medicine
    Stanford University Medical Center
    Michelle Birknow
    Head of Decentralised Clinical Trials Development
    Trial Nation

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    Want to know more or need help?

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

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