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USFDA Guidance: M11 Technical Specification & Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
In a major step toward global harmonisation of clinical trial processes, the U.S. Food and Drug Administration (FDA)Â and the...

Sharan Murugan
Jun 72 min read
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USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
Yesterday (24 May, 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) ánd Center...

Sharan Murugan
May 25, 20232 min read
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ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...

Sharan Murugan
Dec 27, 20222 min read
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