Are Trial Sponsors Treading On Investigators’ Toes In Decentralized Trials?
The Danish regulator’s experience with reviewing and inspecting decentralized elements in clinical trials highlights concerns around the blurring of lines that divide the roles and responsibilities of sponsors and trial investigators.
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The upcoming EU guideline on decentralized clinical trials is the result of a “learning by doing” exercise and builds on various pilots and initiatives launched by different member states.
The Danish medicines regulator has set out its expectations on key elements of decentralized clinical trials as part of Denmark’s ongoing effort to develop a robust regulatory framework in this area.
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.