For years, the laborious step of standardization has ranked as the lengthiest of study startup activities, and recent data suggest it remains the primary cause of site activation failure. Some 50.5 percent of sponsors and 54.3 percent of contract research organizations (CROs) cite it as the main culprit.
Fundamental to changing this impediment are the growing numbers of forward-thinking organization teams who understand the importance of breaking down key benchmarks into their components – the sub-steps – to provide more accurate identification of where bottlenecks might occur.
Measuring these sub-steps is critical to building predictive models that identify processes causing bottlenecks. With a predictive capability grounded in workflow-based metrics, it becomes possible to condense contract cycle times. This presents a significant opportunity for optimizing clinical trial operations.
As the clinical trials sector continues embracing tools designed to capture contracting and budget cycle time metrics, they can empower intelligence and decision making at the site, sponsor, and CRO levels.
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Live: Tuesday, Apr. 30, 2019
1pm EDT | 12pm CDT | 10am PDT
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MICHAEL SULEWSKI, IT Director, Business Relationship Management, Covance-Chiltern
Michael, an IT Director and Business Relationship Manager in the Data and Technology Leadership organization at Covance, is responsible for CTMS, drug safety platforms, resource management, and client integration solutions, as well as five-year technology roadmaps for those areas.Before joining Covance in 2012, Michael had a long career at Hoffmann-LaRoche. There, he held a variety of scientific, project management, operational finance, and clinical operations positions across the diagnostics, medical affairs, and global clinical operations functions. Michael is a passionate information management professional who is proficient at designing and managing value-driven business process collaboration and content solutions, recognized for developing and fostering client partnerships, and acknowledged for combining analytical and problem-solving expertise to deliver business solutions.
KEITH DORRICOTT, Director, Dorricott Metrics & Process Improvement Ltd.
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.
ELVIN THALUND, Director, Industry Strategy, Oracle Health Sciences
Elvin is a recognized industry expert in clinical trials, having over 20 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.