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, ...

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

The FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, ...

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 ...

SUNNYVALE, Calif.--(BUSINESS WIRE)--DvSum, a leader in data intelligence management, is pleased to announce its partnership with Booz Allen Hamilton and the U.S. Food and Drug Administration (FDA) to ...

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...