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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.

Simple DSMB Process

By Ethical 11 Sep, 2023

How simple should a DSMB process be?

The DSMB/DMC process is not as complex as it looks Take the DSMB process for example. It may appear complicated, and indeed it could be a lot of work if managed by hand. But with the right software platform to support the process it should not create notable difficulties to the study team. Let’s look at the DSMB process. A committee of expert...

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DSMB process audit

By Ethical 26 Jul, 2023

The DSMB Process Internal Audit: Why, When and What to look for?

Why conductiong internal audits of a DSMB process? The approval and marketing authorization of a new drug is an important decision made by health authorities that take substantial time to carefully review all the data provided by the sponsor. In addition, health authorities have the obligation to verify the quality of that data to confirm that it h...

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data safety monitoring board software

By Ethical 03 Jul, 2023

What to look for in a software platform for DSMB management?

As discussed in a previous blogpost electronic platforms help address some of the challenges faced by clinical teams and DSMB members by fostering collaboration, enhancing communication and supporting process adherence. In this article, we will step in the shoes of a clinical leader in the position of choosing a software platform for DSMB mana...

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DSMB

By Ethical 15 Jun, 2023

Overcoming DSMB Members Constraints: The Role of Electronic Platforms

What is DSMB a Data and Safety Monitoring Board (DSMB)? DSMBs are dedicated Expert Committees focusing on the safety monitoring of clinical trials to guarantee the safety of participants by advising the sponsor to continue, change or stop the study. DSMB members have a responsibility towards the public at large, in particular towards the participa...

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