Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
Building Quality into Study Startup
Emphasis on quality is everywhere, but in particular, the study startup (SSU) portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall. With unrelenting pressures to rein in budgets and cycle times, stakeholders are turning to quality as a solution, starting with building it into SSU and bringing change to the entrenched siloes that stall trial operations.
Despite this renewed focus, study quality is actually declining despite major advancement in technology over the past 20 years, often due to issues that are preventable.
Reversing this trend means building in quality from the start, and significantly, this approach aligns with regulatory initiatives to upgrade study quality. One of the most widely anticipated was the November 2016 release of the first new Good Clinical Practice guideline (GCP) in 20 years. ICH-GCP E6(R2), defines Quality Management, stating that sponsors should implement a system to manage quality throughout all stages of the trial process, including critical process and data identification, risk identification, evaluation, communication and more.
But how do these guidelines improve overall study quality?
In this webinar we will explore:
- How automated workflows encourage upfront planning and downstream improvements in the eTMF
- Why an upfront emphasis on quality in Study Startup is essential
- How the International Conference on Harmonization ICH-GCP E6(R2) guideline defines Quality Management and builds on the foundation of regulatory documents released by the EMA and FDA
- Why breaking down organizational silos is critical to reducing quality issues
This webinar is applicable to:
- Sponsor and CRO roles responsible for site selection and activation
- Sponsor and CRO roles responsible for collecting and evaluating trial metrics
Keith Dorricott is Director, Dorricott Metrics & Process Improvement Ltd. and an Ambassador for the Metrics Champion Consortium (MCC). Keith has a background in manufacturing from Kodak Ltd. and has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master Black Belt in Lean Sigma quality and process improvement techniques and is an expert in root cause analysis developing a novel approach for clinical trials. He speaks regularly at conferences such as DIA on various topics and runs a number of different metric work groups for the MCC – Vendor Oversight, Data Management / Biostatistics, Trial Master File, Site Selection, and the Study Quality Trailblazer team.
Dorricott Metrics & Process Improvement Ltd
Paul co-founded Montrium in 2005 and has significant industry experience at a senior management level in the development, deployment and management of computerized systems for use in clinical trials. Paul has worked on major clinical technology projects both in Europe and North America and has a strong background in CDISC and ICH standards, and in the integration of systems and processes for clinical trials. He speaks regularly at industry events and is actively involved in several projects for the development of clinical research standards and platforms. Paul holds a degree in management from London Metropolitan University and an MBA in Technology Management from the Université du Québec à Montréal.
President & CEO
Elvin is a recognized industry expert in clinical trials, having over twenty years of experience working as a Clinical Business Analyst Consultant at major pharmaceutical companies including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in goBalto's effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg Universitet.
Senior Director, Product Strategy
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