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Home / eDSMB Blog

Ethical’s BLOG

Stay connected to eDSMB® and Data Safety
Monitoring Boards news in the eClinical World

Ethical’s Director Mimmo Garibbo and colleagues in Clinical Committee Management,  
Software Engineering and Security bring you news and insight on issues, trends,
technology, developments and noteworthy events in the world of Data Safety Monitoring Boards.

By Ethical 18 Oct, 2022

The eDSMB's supervisor profile, what is it useful for?

A clinical drug development program typically consists of several clinical studies, some of which may run in parallel. Whether managed internally or outsourced to a CRO, more than one study in the program may have a DSMB in place so in a typical technical sponsor or CRO environment, several studies are set up under the umbrella of a larger clinical...

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By Ethical 05 May, 2022

DSMB SOP: 9 must-have elements

SOPs are in the heart of the quality system of pharmaceutical and biotechnology companies and are part of a quality pyramid rooted in the policies and standards that define the high-level approach of the company to various business topics and expands down to work instructions and even user manuals of different devices and software. • Policies o St...

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By Ethical 29 Mar, 2022

Why and How to Best Use the Services of DSMBs

Patients accepting to participate in experimental clinical trials must be protected from undue risk during the development of the medicines they need. This principle is the foundation of Good Clinical Practice (GCP) and is clearly stated in the Declaration of Helsinki, the cornerstone document on human research ethics. A DSMB ensures at the same ti...

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