Why did we develop the Decentralised Patient-Centric Trials journey?
Reasons to attend
Pharmaceutical companies are continuously exploring new patient-centric opportunities to improve efficiency in clinical development, better engage with clinical trial participants, and reduce development costs and timelines.
This programme will be a learning journey, where the attendees will not only learn from the expert trainers, but where the aim will be that the entire group forms a community of practice and grows together. There will be case studies and practical workshops to pull everyone out of his or her comfort zone and to find best practices together.
Representatives of study participants, investigational sites, industry, regulatory agencies and vendors will moderate the different events within the journey. This will ensure that every stakeholder involved in decentralised trials is involved in the programme for a holistic view of the process.
The course content will be dynamic and driven by the community, allowing all participants to have a say in the direction of the course and address their needs.
The course provides a mixture of presentations, discussions and practical exercises aimed at providing you with a practical understanding of the new technology and digital channels and how they can facilitate patient-centric decentralised trials.
Discounts for groups:
Documents and materials related to this course are included
Globally recognised certificates awarded after test completion
This course has been granted PharmaTrain Recognition
Remote or decentralised trials offer tremendous benefits to sponsors, patients, investigators, nurses and service providers. We will be taking a deep dive into patient-centric decentralised trial conduct and explore how these trials and modern technology offer new opportunities for all involved and interested in patient-centric strategies.
Traditional clinical trial burdens, such as inconvenient site locations, logistical concerns, time and financial constraints, and missed visits may result in patient dropouts and increase non-compliance. Creating a more patient-centric decentralised trial setting and utilizing smart devices and new technology can help reduce these burdens and enable patients to take part in clinical trials remotely and giving them access to treatment they may not have otherwise.
In addition to providing you with the basics of decentralised patient-centric, this Learning Journey will also provide insight on the regulatory landscape regarding, e.g. Home Nursing, Direct-to-patient IMP shipment and e-informed consent and much more. In other words: this will bring theory into practice!
Theme 1 - Background, history and regulatory situation
Theme 2 - Testimonials from patients and investigational sites
Theme 3 - Remote monitoring
Theme 4 - Patient visits at home
Theme 5 - Investigational product management
Theme 6 - Remote clinical monitoring
Theme 7 - Investigator oversight of patient safety and risk management
Become familiar with the current regulatory requirements related to remote trials
Gain a deeper understanding of what authorities expect regarding patient-centric remote trials
Understand the importance of adapting the trial setting
Understand necessary updates of role profiles, relevant trainings and communication
Share best practices for conducting Decentralised Patient-Centric Trials conduct
Build consensus on hurdles encountered when doing Decentralised Patient-Centric Trials by participating in the community of practice.
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
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