Data Standards For eCOA In Clinical Trials

Adoption of data standards are necessary to underpin higher data quality, efficiencies and integrated applications across increasingly complex clinical research processes. The U.S. Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) have clearly embraced data standards for the submission of data, laying the groundwork for expanded industry adoption. Collecting data in a standardized way is the next step to reduce messy, time-wasting efforts that can negatively impact patient safety, development timelines and resource utilization.

The adoption of data standards for electronic Clinical Outcomes Assessments (eCOA), the fastest growing technology in the eClinical space is critical to ensure quality and efficiency in this rapidly evolving discipline. This webinar will focus on Clinical Data Interchange Standards Consortium (CDISC) standards across data collection, tabulation, analysis and submission. Terek Peterson, the featured presenter, will discuss the benefits of implementing standards and which forms of data collection standards companies are requesting. He will also explore work in development, technology selection and the uncommon roles needed for a standardized eCOA deployment.