How Can Artificial Intelligence Help Clinical Research?

2/05/2020

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The United States Government Accountability Office (GAO) released a report, “Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning in Drug Development.” It outlines six options for policymakers in response to challenges in the use of machine learning in drug development. But why would machine learning be useful in clinical research?

From Safe Harbor to Privacy Shield eLearning Course Now Available for Purchase!

1/28/2020

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What is Privacy Shield?

Privacy Shield is the current agreement for legal transfer of data from the European Union (E.U.) to the United States (U.S.). It is designed to offer stronger personal data protections and insurances of personal data for data subjects in the E.U. When organizations certify under the Privacy Shield Principles, they are benefitting from the European Commission’s adequacy decision for data transfer from the E.U. to the U.S.

What Root Cause Analysis Tools are Effective?

1/19/2020

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SAM Sather and Keith Dorricott co-authored an article published in Clinical Leader entitled, “Clinical Trial Root Cause Analysis: Can't We Do Better Than Five Whys?” If you have experience with Good Clinical Practice (GCP), you may know that ICH E6(R2) now requires sponsors to conduct a root cause analysis (RCA) and implement appropriate corrective and preventive actions (CAPA) for noncompliance “that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results.”