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Home / eDSMB Blog

Ethical’s BLOG

Stay connected to eReconciliation® news
and SAE Data Reconciliation in the eClinical World

Ehical’s Director Mimmo Garibbo and colleagues in Quality Assurance, Software
Engineering and Security bring you news and insight on issues, trends, technology,
developments and noteworthy events in the world of endpoint adjudication.

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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