Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Real-World Quality Management Systems and Data Integrity Compliance Tactics (July 30, 2025)" training has been added to ResearchAndMarkets.com's offering ...

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Pharma 4.0 Focus Data Integrity by Design - Newer Approaches and Technologies to Cost Effective 21 CFR Part 11 Compliance (Aug 19, 2025)" training has ...

Data integrity is an ongoing concern across all R&D organizations, no matter what part of the research lifecycle they’re navigating. These concerns extend beyond the potential for delayed timelines or ...

Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...

Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and ...

What Is Data Integrity & Why Is It Important? (Definition & Types) Your email has been sent Data integrity ensures the accuracy and reliability of data across its entire life cycle. Learn more about ...

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of ...

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 ...

Fresh concerns have emerged about the platelet studies underpinning the FDA approval of ticagrelor, AstraZeneca's multibillion-dollar heart drug. A new BMJ investigation reveals data discrepancies, ...