Description

Clinical Operations Courses

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 1-day course will provide insights to Sponsors, CROs, service providers and Investigational Sites who would like to explore new ways to improve clinical trial conduct and related services by implementing patient-centric remote trials.

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 remote trials.

Virtual or remote trials offer tremendous benefits to sponsors, patients, investigators, nurses and service providers. We will be taking a deep dive into patient-centric remote trial conduct and explore how virtual 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 virtual or remote 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 patient-centric remote trials, this course will also provide insight on the regulatory landscape regarding, e.g. Home Nursing, Direct-to-patient IMP shipment and e-informed consent.

Course time
1 day / from 09h00 to 17h00
Who should attend

This external training is an excellent training opportunity for people external training opportunity for people external training opportunity for people working in areas such:

  • Clinical Trial Management
  • Business Development
  • Patient treatment at Investigational Sites and Patient Service Centers
  • Home Nursing
  • Drug Supply and Shipment logistics
  • Medical Device and modern data collection technology
  • Clinical trial support
  • Freelance CRAs, Nurses and Phycisians
  • Patient Advocacy Groups
  • and others of the healthcare industry interested in patient-centric strategies
Programme highlights
  • Introduction and Basics of patient remote trials
  • Legal landscape
  • Modern data collection, Direct Data Capture and new technology
  • Benefits and challenges
  • Change of role profiles and services
Learning Objectives
  • 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 up-dates of role profiles, relevant trainings and communication
  • Learn how to get prepared for Patient-Centric Remote Trials conduct

 

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)

Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained

Book a course

Date Lang Location
 
Proceeding your application may take up to 24 working hours. In case of question, contact campus@eccrt.com.

Booking is desired 1 week before F2F session in order to allow the participant to go through pre-read materials.
800,00 € excl. VAT (if applicable)