Hiding in plain sight – CRIO eSource is the biggest opportunity for sponsors. While the clinical research industry has automated many processes, there is one area that is still mostly paper-bound. This is the source of one of the greatest inefficiencies in research today. Automating this one process could drive 20% cost savings in a...
CRIO’s integrated eSource-EDC model revolutionizes both the data entry process at the site level and the monitoring process from the CRO perspective. According to a third party survey of CRAs who have used CRIO, CRAs agreed by a margin of 23:1 that this new model would increase overall trial efficiency, improve data quality, and enhance...
Disclaimer: The examples noted in the following article are all firsthand accounts of the author, but for the purpose of this article have been combined into a single site visit. The visit depicted below is an aggregate of many sites and studies and is not necessarily an exact representation. The original version was written entirely...
Good Clinical Practices (GCP) requires that “essential documents” be filed at the sponsor and investigative sites in a timely manner. While the sponsor is responsible for establishing a Trial Master File (TMF), the site is responsible for the Investigator Site File (ISF), which many call the Regulatory Binder. A key part of creating a plan for...