Objectives

Modern drug development, which can take up to 15 years and cost as much as $11 billion USD, relies heavily on high-quality data1. Recognizing the criticality of attaining quality data that is easily convertible to analysis-ready datasets, a survey was developed to obtain baseline information on data quality and data standards, largely from a CRO perspective. Recognizing: 1) that a process of curation, quality assessment and integration is required to achieve analysis-ready data and 2) that it is often a rate-limiting step for projects with modeling and simulation deliverables, we postulate that the impact of these activities on project timelines is often under-appreciated and under-estimated.

By Amparo de la Peña, Jill Fiedler-Kelly, Rebecca Humphrey, Jeff Barrett