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Data Management Clinical Trials Regulatory Oversight

Hogan Lovells

FDA warns of “important” clinical trial protocol deviations

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The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more

Hogan Lovells

The EMA launches a public consultation on eSource Direct Data Capture in clinical trials

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The European Medicines Agency (EMA) has published a draft qualification Opinion concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU....more

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Clinical trials: Digital technology for recruitment, consent, and data capture

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The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

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