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Unsure About The New ICH Guidelines? TransCelerate Debuts 13 Tools To Help

If you’ve begun combing through the new ICH GCP E6(R3) guidelines to understand how the updates will affect your clinical research practices and feel just a little lost or overwhelmed, you’ve got help. TransCelerate BioPharma, in a partnership with the Association of Clinical Research Organizations (ACRO), has designed and released 13 tools to support E6(R3) adoption across six focus areas.

Read the full article by Tashan Mistree from Clinical Leader here.

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