ECRIN Toolbox for Master Protocol clinical trials...

  • 10/12/2025

The MaP Toolbox gathers in one place more than 100 resources (and growing!) to support researchers in planning, designing, and conducting these complex trials.

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PubMed warns!

  • 10/2/2025

Due to funding cutoff of the USA government PubMed warns that it may not function properly…

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Artificial Intelligence in Peer Review

  • 8/31/2025

JAMA published an editorial on "Artificial Intelligence in Peer Review"

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CIOMS released version 8 of the Glossary of ICH terms and definitions

  • 6/20/2025

The glossary is 247 pages and includes newly added definitions

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WHO is emphasizing on transparency in clinical trials....

  • 6/13/2025

According to WHO, registration of clinical trials is widely recognized but reporting is not...

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FDA introduces new placebo trial requirement for COVID-19 vaccines...

  • 5/31/2025

The details are published in an article on NEJM written by FDA authorities

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European Medicines Agency (EMA) released a draft reflection paper biosimilar development....

  • 5/20/2025

The European Medicines Agency (EMA) is exploring an improved approach for biosimilar medicine development and evaluation, while upholding strict European Union (EU) safety standards

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The European medicines regulatory network’s vision for clinical evidence by 2030 has been published...

  • 2/18/2025

This scientific article describes 6 guiding principles for generating excellent clinical evidence

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ICH E6 (R3) final version online...

  • 1/23/2025

After the draft R3 of ICH E6, the final version is online...

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Is it necessary to submit a DPIA to Regulatory Authorities for Clinical Studies in the EU?

  • 1/6/2025

An Overview of the Requirements in France, Ireland, and Spain by VeraSafe

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