Global CRO Body Urges Sponsors To Focus On Key Risk Factors As Coronavirus Threatens To Upend Clinical Trials
New guidance by the Association of Contract Research Organizations aims to ensure that data quality is unaffected, clinical trial sites are supported and patients are kept safe.
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EU Urges Sponsors To Assess COVID-19 Impact Before Starting New Trials
New EU guidance on managing clinical trials in the context of COVID-19 requires sponsors to critically assess the feasibility of starting a new clinical trial or including new participants in an ongoing trial. A separate survey indicates that patient willingness to participate in new trials has dramatically declined due to the pandemic.
UK MHRA: COVID-19 To Spark Rise In Clinical Trial-Related Deviations
The UK’s Medicines and Healthcare products Regulatory Agency says that any increase in clinical trial protocol deviations in relation to coronavirus outbreak will not constitute a serious breach.
Global Medtech Guidance Tracker: May 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-seven documents have been posted on the tracker since its last update.