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    EU Regulatory Roundup: Rising Complexity Drives Sharp Fall in MHRA Pharmacovigilance Inspections

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Advises Novartis on use of eSource Direct Data Capture in Clinical Trials   The European Medicines Agency (EMA) has outlined its views on eSource direct capture of clinical trial data in response to questions from Novartis. EMA sees no theoretical obstacles to the use of the technology in a way that complies with good clinical practices (GCPs), but thinks sponso...
  • Revised Draft Guidance Calls for Greater Use of Electronic Data

    US regulators have released a new draft guidance document aimed at providing industry with insight on the use of electronic source data in clinical investigations . The guidance, set to be published on 20 November 2012 and summarized in a 19 November Federal Register posting , specifically relates to those involved in the capture, review and archive of electronic source data in FDA-regulated clinical trials. Explains FDA: "The revised draft guidance promotes captu...