January 03, 2022
New requirements must be put in place to ensure data quality and integrity.
April 01, 2017
How to assure that software used in clinical trials will support regulatory scrutiny during pre-approval inspections and application review.
February 06, 2017
When designing and using an electronic informed consent form, there are many factors that should be considered when applying to clinical research.
January 04, 2017
The time is now for sites and sponsors to put away fears associated with data acquisition and monitoring technologies-and better support the regulatory push in recent years for standardized adoption of paperless trials.
August 01, 2015
How to satisfy regulatory concerns about EDC data integrity and site controls over its source records.
April 16, 2015
Figure 1: The Problem