The Danish Medicines Agency has launched a pilot to put an end to what it says is an ongoing “waiting game” with drug sponsors on the topic of decentralized clinical trials.
Denmark Tackles ‘All Talk And No Action’ On Decentralized Clinical Trials
EU Allows Expanded Use Of Remote Source Data Verification
Danish regulators tell the Pink Sheet they want to know what is holding companies back from submitting applications for decentralized clinical trials and are keen to find creative solutions to possible hurdles.
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The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
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