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EMA Updates GCP Guide To Clarify Sponsor Role In Contracting For Trial-Related Tasks

 
• By Vibha Sharma

Based on the trial design and setting, the European Medicines Agency says the sponsor may support the investigator by identifying or contracting service providers or personnel to be involved directly in the conduct of the clinical trial.

African doctor wear headset consult female black patient make online webcam video call on laptop screen. Telemedicine videoconference remote computer app virtual meeting. Over shoulder videocall view.
The investigator is ultimately responsible for any tasks involving trial-related medical decisions • Source: Shutterstock

The European Medicines Agency has updated its good clinical practice (GCP) guidance to support changing trends in the conduct of clinical trials, such as the increasing tendency of sponsors of decentralized clinical trials (DCTs) to get involved in contracting service providers for tasks that traditionally fall within the remit of the trial investigator.

The GCP Q&A has also been updated to address the use of productivity software in clinical trials, for example, to...

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The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

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The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

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Eisai and Lilly explain why they disagree with today’s conclusion by the health technology assessment institute, NICE, that the benefits of their respective drugs for Alzheimer’s disease are too small to justify the additional cost to the National Health Service.

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
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More from Geography

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As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.

Not Over Yet: Eisai And Lilly To Appeal England’s ‘Flawed’ Refusal To Fund Leqembi And Kisunla

 
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Eisai and Lilly explain why they disagree with today’s conclusion by the health technology assessment institute, NICE, that the benefits of their respective drugs for Alzheimer’s disease are too small to justify the additional cost to the National Health Service.

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