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, ...
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, ...
PharmTech

Evolving Regulatory Systems Stress Importance of Data Integrity

A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, address data integrity within the context of revised or new parts of the ...
Forbes

Why The FDA And Others Should Use Blockchain To Guarantee Authenticity

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 ...
The Scientist

Why Data Integrity Is an Ethical Obligation, Not Just a Scientific One

Human data and samples are scientific gifts, and scientists must be stewards of them, ensuring that they are collected and ...