Linking Study Quality to Upfront Planning
Proactive Planning Key to Improving Clinical Trial Quality
A well-known cliché advises that if you fail to plan, you are planning to fail. When it comes to study startup (SSU) these words ring true, especially as the clinical trials sector is making strides in boosting study quality. With the help of cloud-based SSU tools, proactive planning is becoming essential, as stakeholders are developing processes that enable them to always be audit-ready, and increase their likelihood of passing regulatory audits.
Getting it right from the beginning—prior to site activation—is the key, and requires taking an upfront approach, whereby sponsors and contract research organizations (CRO) identify what is needed to mitigate risk.
Too often, these issues are not hammered out upfront, resulting in problems developing, but not being identified until much later, after completed documents have been released to the eTMF. This means that problems, such as missing or incomplete documents, may go unnoticed until this late date, when the study is already underway. Reversing this trend means building in quality from the start, and significantly, this approach aligns with regulatory initiatives to upgrade study quality.
But how can workflow solutions 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, including what factors to consider in order to mitigate risk (e.g., Which countries will be used? Which sites/investigators will be used? Which artifacts need to be identified and structured? etc.)?
- 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
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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