News

Applied Clinical Trials

The Office for Human Research Protections at the US Department of Health and Human Services and the US Food and Drug Administration issued a final guidance on May 17 on Institutional Review Board written procedures, which are required under both OHRP and FDA regulations.

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Applied Clinical Trials

Findings from a new ACT and SCORR Marketing survey reveal the most actively used flexible design approaches in clinical research-many with application in rare disease.

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Applied Clinical Trials

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.