Quality in Clinical Research

Description
Quality

Quality is the buzzword these days in the clinical research field. But what does quality mean and how is it established? This TRIUM Training introduces the concept of quality in the context of a clinical trial’s regulated environment and explains how Quality Management Systems should be set up to ensure all elements like processes, resources, partners, risks, issues and knowledge management are interconnecting in order to avoid or mitigate high risks.

After a theoretical introduction to the skills and techniques you will have opportunity to practice and learn from you peers using real clinical research case studies and examples. A handy job aid summarizing the key take-aways will be handed out at the end of the training day to help you transform your newly learned skills into actual performance.

At the end, you will receive a certificate for attendance and handy hand-outs for use in the field.

Learning objectives

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

  • Describe the therapy development process and its related regulations and guidelines
  • Define Quality Assurance (QA), Quality Control (QC), monitoring, audits and inspections, Quality Management (QM), Quality Management System (QMS), Quality by Design (QbD), risk management and risk assessment, Root Cause Analysis (RCA), Corrective Action Preventive Action plan (CAPA)
  • Critically assess clinical trial quality management strategies and related procedures and systems
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.”