The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...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issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...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 ...
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 ...
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, ...
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 ...
The present world of digital transformation, streamlining workflows, enhancing operational efficiencies, and eliminating paper demands connected workflows with fully integrated systems and equipment.
Minor data corruptions accumulate silently over time and undermine analytics, operational efficiency and regulatory ...
In the age of advanced data analytics and artificial intelligence (AI), organizations are continuously confronted with new and increasingly complex challenges of data legitimacy. The proliferation of ...
In May 2022, the Office of Inspector General (OIG) conducted unannounced inspections of U.S. Customs and Border Protection (CBP) facilities in the Rio Grande Valley area of Texas, specifically six U.S ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback