Applied Clinical Trials-10-01-2001

Applied Clinical Trials

Serious Adverse Event Reporting

October 01, 2001

Feature Article

Getting answers to the right questions can help you decide how to choose and implement an electronic system that is a good match for your company's SAE reporting needs and its available resources.

Clinical Research Software

October 01, 2001

Feature Article

A systematic survey of 96 pharmaceutical companies and clinical research organizations revealed which systems sponsors are using for clinical data management and adverse events tracking and reporting.

EU Drafts Research Guidance for Diabetes Treatment

October 01, 2001

View from Brussels

The EU?s Committee for Proprietary Medicinal Products describes the process clinical investigations should follow.

The Evolution of Electronic Submissions

October 01, 2001

Technology Viewpoint

Making electronic CRFs friendly to both investigators and reviewers is a challenge.

Human Research Oversight Expands

October 01, 2001

View from Washington

While Health and Human Services builds a comprehensive program to ensure the safety of human subjects, Congress weighs proposals to stiffen the rules.

Planning an EDC Clinical Trial

October 01, 2001

Notes from the Field

Readers share their experiences