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drug development

Patient Engagement and Real-World Data Drive Innovation in Orphan Disease Drug Development

An estimated one in 10 people are affected by a rare disease, and the cumulative economic burden of rare diseases surpasses that of common conditions …

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Querying the Queries – An AI Approach to Manage Clinical Data Quality

High-quality clinical trial data is essential for a successful clinical trial. This data is the foundation for the analysis, submission, approval, labelling and marketing of …

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clinical trials

The Role of The Falsified Medicines Directive and Delegated Regulation in The Supply Chain of Clinical Trials

Companies providing clinical trial supply services to sponsors and contract research organisations (CROs) need to comply with a complex framework of regulatory requirements and industry …

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Intricacies and Future Considerations for the Cell and Gene Therapy Cold Chain

The rapidly growing field of cell and gene therapy is both exciting and confusing to many, including those who work in the medical community and …

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