Title: Operational Efficiency Across the Study Lifecycle

Presenter: RICHARDSON, Andy, d-Wise

Organisation: d-Wise


The need to improve operational efficiencies is ever more pressing to the delivery of quality clinical trial data.  New systems, particular as they relate to the use and compliance with regulatory standards (specifically CDISC), are necessitating an end-to-end reappraisal of operational efficiencies. Whilst DM has autonomy with respect to activities such as database build and query management, data delivery to programming and stats groups requires coordination, as does study protocol specifications from clinical groups.  Supporting metrics for these functions need to consider all these interactions to enable overall study lifecycle operations are optimally delivered.  Efficiency ratios offer an approach to measure operational efficiencies that can be used both within and between functional groups, and can be used to compare otherwise disparate functions.   The potential value of efficiency ratios to support clinical programming tasks has been published elsewhere [Richardson 2017 PhUSE Edinburgh PP05]. This presentation extends this work and shows how it can support DM operations whilst at the time illustrating how they can help.with determining the up-steam and down-stream effects of DM operations on other groups.

Learning Objective 1: Efficiency ratios as an adjunct to ‘traditional’ metrics

Learning Objective 2: Value to compare operations accross the study lifecycle

Learning Objective 3:


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