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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.

Five Technological Implications of ICH E6(R3) for Data Safety Monitoring Board (DSMB) Software

By Ethical 01 Jul, 2025

Five Technological Implications of ICH E6(R3) for Data Safety Monitoring Board (DSMB) Software

As clinical trials become more complex and decentralized, the role of Data Safety Monitoring Boards (DSMBs) is more challenging— and more critical— than ever. The new ICH E6(R3) guidance directly addresses the shift in data sources and collection, introducing updated expectations for risk-based oversight, data integrity, and the abilit...

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GCP Compliance for DSMBs Key Requirements and Solutions

By Ethical 24 Jan, 2025

GCP Compliance for DSMBs: Key Requirements and Solutions

Good Clinical Practice (GCP) plays a central role in ensuring the integrity of clinical trials and safeguarding participants. Data Safety Monitoring Boards (DSMBs) or Data Monitoring Committees (DMCs) contribute to the task as they oversee trial safety and efficacy through unbiased, expert-driven decisions. While their independence is essential, un...

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The Role of DSMBs in Clinical Trials: Ensuring Safety and Integrity

By Ethical 04 Dec, 2024

The Role of DSMBs in Clinical Trials: Ensuring Safety and Integrity

Why Are DSMBs Essential? DSMBs are tasked with the periodic or even continuous monitoring of clinical trials. They evaluate unblinded data to assess the risk-benefit profile of the investigational product. If a treatment demonstrates significant superiority over standard care or raises safety concerns, DSMBs may recommend adjustments to the trial, ...

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Ethical Welcomes Advarra to our CRO-Safe Partnership Program

By Ethical 22 Nov, 2024

Ethical Welcomes Advarra to our CRO-Safe Partnership Program

At Ethical GmbH, we are thrilled to announce an exciting new partnership with Advarra, the market leader in regulatory review solutions and clinical research technology for sites, sponsors, and clinical research organizations (CROs). Advarra has officially joined the Ethical CRO-Safe Partnership Program, integrating our cutting-edge eDSMB® and ...

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