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From 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014, life sciences firms will be expected to prepare plain-language summaries for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts.

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A global CRO’s data gathered using an objective monitoring simulation administered by CRA Assessments, LLC reveals that CRAs are consistently underperforming regardless of the level of experience or training.

On Europe Day, the agency itself is right now keener than ever to assess its worth and the value of its services to Europe and to Europeans.