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Human Factors Testing and Clinical Research

by SOCRA | Apr 15, 2020 | Clinical Research, Investigational Drugs and Devices (IDE/IND)

Tim Reeves, CHFP Founder and Managing Director Human Factors MD Abstract: Human factors simulated-use studies provide a valuable tool for evaluating the usability and safety of medical devices, including combination products such as inhalers, injection devices, and...

Reducing Over-reporting to INDs and Increasing Efficiencies at Clinical Research Sites

by SOCRA | Oct 9, 2019 | Investigational Drugs and Devices (IDE/IND)

Sarah Attwood, BScDirector of Client ServicesIntegReview IRB Abstract: Institutional review boards (IRBs) continue to be overburdened with reports not required by federal regulations. It is important to understand the difference between what the regulations require...

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Promoting excellence in clinical research professionals through education, CCRP® certification, and community, leading to ethical, high-quality research, protection of participants, and global health improvement since 1991.