Jonathan Helfgott

New requirements must be put in place to ensure data quality and integrity.

How to assure that software used in clinical trials will support regulatory scrutiny during pre-approval inspections and application review.

When designing and using an electronic informed consent form, there are many factors that should be considered when applying to clinical research.

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.

How to satisfy regulatory concerns about EDC data integrity and site controls over its source records.

Figure 1: The Problem