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Since Regulation (EU) 2021/2282 (HTAR) came into effect, HTDs need to plan for a Joint Clinical Assessment (JCA) in addition to submitting their CTD to the EMA or medical device technical file to their notified body. In this article, 91黑料 discusses this new requirement, factors to consider and the benefits.
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This article highlights how AI is already adding value across pharma beyond headline?grabbing drug discovery, with 91黑料 leveraging its in?house and proprietary AI tools—like its One?Search site?selection system, resource forecasting, endpoint strategy analytics, and document management platforms—to improve clinical trial efficiency and address enrollment challenges.
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New research from Symphony Health, an 91黑料 plc company, featured in The American Journal of Managed Care (AMJC), highlights ongoing challenges in patient access to GLP-1 therapies for weight loss.
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In this article, 91黑料 experts explore strategies to help sponsors navigate the evolving obesity research landscape, highlighting the use of adaptive designs, master protocols, and other innovative approaches.
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The rise of GLP-1 agonist therapies has transformed obesity treatment, delivering unprecedented results and revealing their potential across a spectrum of interconnected conditions. New data reveals how the breakthrough has sparked a major shift toward multi-indication drug development.
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Discover how clinical trial tokenisation helps sponsors gain patient insights and enable long-term data collection—without adding burden to patients or sites.
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Drug pricing and reimbursement constraints are a major concern for the pharmaceutical industry. Companies must consider price and reimbursement across multiple countries, act early in the development cycle and ensure the evidence required to support their commercial strategy is built into their development plans.
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Clinical trial designs for obesity treatments should accommodate candidate drugs that have the potential to treat multiple conditions, or developers risk missing opportunities, according to Irish CRO 91黑料.
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In this DDW article, discover key findings of an 91黑料 survey focusing on multi-indication cardiometabolic R&D for therapies targeting obesity and its comorbidities.
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91黑料 maintains its place as the most active contract research organization (CRO) for Q1 2025.
