Current Edition

Cardiovascular Medical Devices Watch Column
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Cardiovascular Medical Devices Watch Column

In this new column, Dr Allen Kindman and colleagues will be highlighting ‘hot topics’ in the development and therapeutic use of cardiovascular medical devices. Dr Kin...
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Engagement Shouldn’t Stop at Patients

The clinical technology industry has spent many years working to improve the experience of participating in clinical trials for patients. Following the initial enthus...
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Guidance on Submissions for Integrated Summary of Effectiveness
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Guidance on Submissions for Integrated Summary of Effectiveness

For more than 30 years, the US Food and Drug Administration (FDA) has required sponsors of new drug applications (NDAs) to include in their submission an integrated s...
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The Use of Mobile Technology to Support Patients and Complex Protocols in Clinical Studies
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The Use of Mobile Technology to Support Patients and Complex Protocols in Clinical Studies

For clinical trials to be truly successful, adherence to protocols is essential. However, as trial designs become more complex, sponsors are seeing a worrying fall...
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Considerations for Oncology Clinical Trials in Asia
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Considerations for Oncology Clinical Trials in Asia

Asia is an important destination for oncology clinical trials, accounting for half the global burden of cancer, with disproportionate levels of liver, stomach, and...
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Adjuvanted Seasonal Influenza Vaccine Development
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Adjuvanted Seasonal Influenza Vaccine Development

In this article, Walter Chalkley, Senior Editorial Project Manager for Cortellis Regulatory Intelligence, outlines the current situation with regard to the use of ...
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