The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...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issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...

With regulatory agencies like the FDA, EMA, and MHRA intensifying data integrity compliance, significant market opportunities exist in providing robust data management solutions. Organizations can ...

DUBLIN--(BUSINESS WIRE)--The "Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance" training has been added to ResearchAndMarkets.com's offering.

The market opportunities lie in leveraging data process mapping to enhance data integrity and regulatory compliance, particularly aligning with FDA standards. There's potential in addressing gaps, ...

The FDA has intensified its focus on data integrity in computer system validation during inspections and audits, emphasizing the critical role of compliance in systems utilized across regulated ...

Market opportunities arise from the growing need for modernization and compliance assurance in FDA-regulated industries focusing on data integrity. Emphasizing cloud computing, automation, and mobile ...

FDA investigation into BioXcel's TRANQUILITY II study raises concerns about data integrity and management of the trial, impacting stock uncertainties. FDA's Type C meeting on November 8, 2023, will ...

SUNNYVALE, Calif.--(BUSINESS WIRE)--#DvSum--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 ...

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

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 ...

NEW HAVEN, Conn., Oct. 25, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience ...