Learn how to implement decentralised elements in clinical trials and to leverage digitalisation for clinical research
29 Aug, 19 Sep, 3 Oct and 24 Oct 2023
On location
English
(app. 2,635 EUR ex VAT)
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.
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:
"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
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.
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:
Overview of DCT
Group work
Study design, patient involvement, protocol, suitable endpoints. Samples/ measurements. Trial phase and location considerations.
Challenges with informed consent and digitalisation. Patient and investigator training. IMP supply. Monitoring and reporting of safety. Compliance tracking.
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.
Leveraging digital date to optimise clinical trial planning
Optimising clinical trial planning
DCT thinking by the health authorities and ethics committees
Hands-on practice: engaging with potential DCT vendors
Handing out of course certificate
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").
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.
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.
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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