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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.

DSMB Challenges

By Ethical 14 Mar, 2023

Managing DSMBs: Top 5 Challenges and How to Overcome them

DSMBs and DMCs (the terms are largely interchangeable in clinical research jargon), play a key role in the monitoring of blinded randomized clinical trials (RCT) and the more complex and the longer the trial, the bigger need for independent committees that can review summary data in search of safety signals. The use of a DSMB guarantees that partic...

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audit trail clinical trial committees

By Ethical 21 Feb, 2023

Audit trail of a clinical committee process: the invisible string to compliance

An audit trail is the part of metadata allowing to track the key parameters of a digital record: when the record was created, in which environment or system, by whom, who reviewed it and when, who approved it, and so on. If metadata such as dates of issuance, dates of validity or all other important information allowing to identify digital records...

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By Ethical 24 Nov, 2022

Preventing your trial data confidentiality breaches with eDSMB

New cases of data leak either accidental or malicious quite often capture the headlines. Any company or institution is potentially at risk and the downstream consequences can be severe: a data leak can reveal trade secrets but also jeopardize patient confidentiality, potentially harming a company’s reputation and even affecting stock price fo...

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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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