Decentralised Clinical Trials – From Theory to Practice
Book a session
Date | Product | Location | Price | |
---|---|---|---|---|
22/05/2025 | Decentralised Clinical Trials – From Theory to Practice | Brussels | EUR 1775 | Book |
If you would like to have this course as an in-house session click here |
About this course
Reasons to attend
Pharmaceutical companies are constantly seeking new ways to enhance the clinical development process by focusing on the patient experience, fostering greater engagement with clinical trial participants, and streamlining costs and timelines. This course will introduce you to decentralised trials, the new and innovative approach to conducting clinical trials. In this course, we will cover various aspects of decentralised trials, including current state-of-the-art, key benefits, challenges, and opportunities. You will learn about the different types of decentralised trials, their use cases, and the various stakeholders involved in the process. Furthermore, we will delve into the technical aspects of decentralised trials, including the use of digital tools to facilitate data collection, IMP and biosample handling, and home nursing. You will also learn about the regulatory and ethical considerations surrounding decentralised trials and the measures in place to ensure patient privacy and security.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
This session is organised as a 2-Day classroom training from 9:00 to 17:00Course Description
The concept of remote or decentralised clinical trials offers numerous advantages to stakeholders such as trial sponsors, study participants, investigators, nurses, and service providers. During this course, we will delve into the specifics of decentralised trial conduct and examine how this trial setting and modern technology offer new possibilities. The challenges associated with traditional clinical trials, including inconvenient trial locations, logistical issues, time and financial constraints, and missed appointments, can lead to high rates of patient dropouts and decreased compliance. By shifting to a decentralised trial setting and leveraging smart devices and advanced technology, these obstacles can be reduced, allowing patients to participate in trials from the comfort of their own homes and access treatments they may not have otherwise been able to receive. Beyond providing a comprehensive understanding of decentralised trials, this course will also offer insights into the regulatory environment surrounding topics such as home nursing, direct-to-patient shipment of investigational products, and electronic informed consent, among others. This course aims to provide a collaborative and enriching experience, where attendees will not only receive instruction from expert trainers but also have the opportunity to learn and grow as a cohesive community. Featuring interactive case studies and hands-on workshops, it will challenge participants to step out of their comfort zones and work together to identify best practices. Additionally, the course will offer a diverse mix of lectures, group discussions, and hands-on activities, aimed at imparting a practical understanding of the latest technology and digital platforms, and how they can support decentralised clinical trials. By the end of the course, you will have a deep understanding of the concepts, challenges, and opportunities associated with decentralised trials and how they are shaping the future of medical research. In essence, this program will bridge the gap between theory and practice.Programme highlight
- Theme 1 – Introduction to Decentralised Trials
- Theme 2 – Stakeholders in Decentralised Trials
- Theme 3 – Technical Aspects of Decentralised Trials
- Theme 4 – Regulatory and Ethical Considerations
- Theme 5 – Designing and implementing DCTs
- Theme 6 – Home Nursing
- Theme 7 – IMP Management in DCT
- Theme 8 – Safety Events & clinical monitoring
Learning objectives
- Stay up to date with the latest trends: Decentralised trials are a rapidly evolving field, and this course will keep you informed of the latest developments and current regulatory requirements in this area.
- Enhance your skills: By attending this course, you will gain new skills and knowledge on how to conduct decentralised trials, which are in high demand in the industry.
- Career advancement: Decentralised trials are an important area of research and development, and having expertise in this field can lead to opportunities for career advancement.
- Learn from industry experts: The course is taught by experienced professionals who have been at the forefront of the decentralised trials field. They will share their insights, experience, and practical tips with you.
- Networking opportunities: Attending this course provides an excellent opportunity to network with other professionals and experts in the field, which can be valuable for your personal and professional growth.
- Improve patient outcomes: By learning about decentralised trials, you will have the knowledge to contribute to improving patient outcomes by ensuring that trials are conducted more efficiently and effectively.
Who should attend
This training is an excellent opportunity for people working in areas such:
- Clinical Trial Management
- Clinical Innovation Teams
- Regulators, Health agencies driving innovation
- Investigational Sites and Patient Service Centers
- Home Nurses involved in clinical trials
- Drug Supply and Shipment Logistics staff
- Medical Device and modern data collection technology providers and users
- Clinical trial support staff
- CRAs, Nurses and Physicians
- Patient Advocacy Groups and patients
- Other healthcare industry roles interested in patient-centric strategies and decentralised trials
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (2)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (1)
- Clinical Studies Operations (GCPs or ISO 14155) (6)
- Study and Site Management (4)
- Data Management and Informatics (5)
- Leadership and Professionalism (2)
- Communication (1)
- Teamwork (1)
- Business acumen (0)
Soenen Rani
UZ Gent