The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...
Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...
BioXcel Therapeutics faces regulatory challenges after the FDA found inconsistencies in one of its clinical trial sites, jeopardizing the supplementary approval of its drug, IGALMI. BioXcel's ...
Risk management executives can no longer treat artificial intelligence (AI) as a passing fad. According to a report from ...
Minor data corruptions accumulate silently over time and undermine analytics, operational efficiency and regulatory ...
DUBLIN--(BUSINESS WIRE)--The "Data Integrity and Document Management Training Course" conference has been added to ResearchAndMarkets.com's offering. Document management and data integrity are a key ...
In a recent Hayes Management Consulting blog, Leala M. Williams explains if Biometric identification is the answer to patient data integrity issues. Long gone are the days of standalone demographic ...
Throughput, efficiency, and reproducibility are key concerns in laboratory studies. Advances in digital science solutions and automated technologies are driving recent improvements in lab results, ...
Sharon Regional Health System faced a dilemma after completing a comprehensive master patient index cleanup in preparation for its new electronic health record system. While the cleanup had eliminated ...
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