JD Supra

Addressing Data Integrity Challenges in Medical Device Submissions

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, ...
News Medical

The critical role of data integrity in ensuring pharmaceutical quality

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

FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

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, ...
Business Wire

Data Integrity and Document Management Training Course: Discussion of the Latest MHRA Data Integrity and EMA TMF Guidelines (ONLINE EVENT: December 6, 2024/ON-DEMAND ...

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 ...
Applied Clinical Trials Online

Clarifying Ownership of IRT Data in Clinical Trials: Distinguishing Investigator-Controlled Data from Sponsor Operational Data

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 ...