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...
Running a Study
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...
Running a Study
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...
Running a Site
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...
