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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Advarra

The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Non-EU companies must comply with the AI Act if their AI systems are used in the EU market.

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Key Trends Drug Developers Need to Know to Succeed

PPD

In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends. Small/mid-size participants in particular indicate greater use of DCTs, expecting higher use by 2026.

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Guest Blog: Reflecting on the 2024 Society of Toxicology of Canada Symposium, by Ria Falvo, Director, Reporting

Alta Sciences

Their passion and curiosity to expand the boundaries of toxicology research illuminated the room. As experts in early-phase drug development , from discovery through Phase II clinical research , we at Altasciences can share with STC members our accumulated knowledge and experience, and provide mentorship for future toxicologists.

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Sequana Medical to present at Jefferies 2020 Virtual London Healthcare Conference

The Pharma Data

and EU5 by 2026. The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR therapy is not currently approved for clinical research in the United States or Canada.

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Sequana Medical Appoints Two Additional Experts as Heart Failure Scientific Advisors

The Pharma Data

He is Director of Cardiovascular Research at the Duke Clinical Research Institute and Vice-Chief for Clinical Research in the Division of Cardiology. and EU5 by 2026. The DSR therapy is not currently approved for clinical research in the United States or Canada.

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Sequana Medical Announces January 2021 Investor Conference Schedule

The Pharma Data

and EU5 by 2026. The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR therapy is not currently approved for clinical research in the United States or Canada.

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. The study is planned to begin in 2026 and conclude in 2028. Read AgencyIQ analysis here for a detailed discussion of these issues. ]. See AgencyIQ’s analysis of the draft guidance here. ].

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