Clinical Trial Conduct Post COVID-19: How to Handle the New Reality?

Description
General

Needless to say that the COVID-19 pandemic has and still is impacting the way clinical trials are conducted. Local regulatory bodies offered guidance on behavioral and documentation expectations. As we go slowly back to a ‘new normal’, there are still many unknowns. Questions answered during this 30 minutes session are, amongst others: Are these alternative ways of working to stay or will we go ‘back to before’? What are acceptable and feasible ways to conduct remote monitoring/auditing? Is there an alternative for onsite SDV that is acceptable in the EU? Is the upcoming GCP E6 R3 standard supporting use of technology and alternative trial designs to weapon us again another disrupter like COVID-19?

Do join us, so we can shed some light on the darkness and help you be better prepared for the future.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Describe best practices in trial conduct post COVID-19 pandemic, ensuring subject safety and well-being, qualitative data and regulatory compliance
  • List the key changes between GCP E6 R2 and GCP E6 R3
  • Describe how GCP E6 R3 is supporting a new research framework that ensures better protection against disrupters like e.g. a virus pandemic
Training design
Webinar/Live Online
Training duration
30 minutes
Training Language
English
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”