Data Management

Benefits of business 4.0 approach in EDC in med-dev studies.

Spotlight on clinical trials created by COVID-19 pandemic has forced regulatory officials around the world to expand disclosure requirements on results.

The right person can successfully promote proper management of quality and compliance, leading to desired clinical trial outcomes.

Flexibility to work on assignments whenever one's schedule permits can be the only realistic way to pursue further education.

Think about how you wish to use ODM across an organization, not just within a single trial. All that needs to happen is for the same identifier to be used to denote two different studies and the data for both appear to come from the same study!

In the mid to late '80s, a tool called remote data entry was available which replaced double key data entry and paper case report forms (CRFs) at the clinical trial study site. When remote data entry (RDE) was used, the drug sponsor would provide a portable computer to the investigational site. The coordinator would collect study-related patient data, and then enter the data directly into the computer via the specially designed user interface of data entry screens. The electronic data would then be monitored. After data cleanup, a floppy disk with the site's data would be sent to the sponsor via an overnight courier service. These tasks would occur periodically during the course of the clinical trial.