Electronic Clinical Trial Management Systems: The Basics, Needs, and Outputs

Michael Wieczerzak
Associate Director, Clinical Quality Management, EMD Serono


Abstract: Sponsors and contract research organizations should be using electronic clinical trial management systems to efficiently oversee their trials. This article describes the basic structure of clinical trial management systems and the need for these systems. Benefits of using an integrated clinical trial management system are highlighted, including the ability to link to other systems, running reports, and outputs such as executive management reporting dashboards, listings, and merged datasets. Requirements for compliance with 21 CFR Part 11 are described.

Disclosure: The author is not writing this article on behalf of his employer.

Continue reading Electronic Clinical Trial Management Systems: The Basics, Needs, and Outputs

A Modern CRA Perspective on the Use of Technology in Clinical Trials

By Takoda Roland, CCRA, CCRP

Founder of Philadelphia Pharmaceutical Research

Disclaimer: The examples noted in the following 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 on a smartphone while flying from Philadelphia to Puerto Rico.

Continue reading A Modern CRA Perspective on the Use of Technology in Clinical Trials