Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?

Sep 26, 2017
By goBalto

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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?



Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd

Paul Fenton, President and CEO, Montrium

Elvin Thalund, Senior Director, Product Strategy, goBalto


Date and Time:

Live: Tuesday, 26 September at 1 pm EDT | 12 pm CDT | 10 am PDT

After the final airing of the webcast 26 September 2017 it will be available on demand until 26 September 2018. 

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