New EU Clinical Trials System Could Support Patient Recruitment
The EU research-based pharma industry is exploring partnerships to develop an app that would extract data from the new Clinical Trial Information System and convert it into lay format to guide patients interested in participating in studies.
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Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements.
The digitalization of clinical trials is generating more patient safety data than companies can process. A senior EMA official says sponsors should carefully select what is needed to maintain appropriate subject oversight by “getting the science right.”