FDA’s Transparency Roadmap: What It Means for Clinical Trial Disclosure
By James Greene Key Takeaways The US Food & Drug Administration (FDA) has put public release of Clinical Study Reports on its agenda. For US sponsors, clinical document…
Topic
Regulatory Compliance
FDA Flags Thousands of Missing Clinical Trial Results. Is Your Team Prepared?
The FDA recently contacted more than 2,200 sponsors and researchers connected to over 3,000 clinical trials that may be missing required results reporting on ClinicalTrials.gov. In an FDA…
New Webinar Announced on Stronger Clinical Document Authoring Workflows with Certara & TrialAssure
The completion of clinical document authoring is not the end of the road, but rather the beginning of the lifecycle of these documents. Their journey includes many additional…
TrialAssure’s Zach Weingarden Joins Other Pharmaceutical Industry Leaders to Present on the Future of AI in Drug Development at RAPS Convergence 2025
CANTON, Mich. and PITTSBURGH (August 2, 2025) – TrialAssure, a global leader in AI-enabled, human-driven solutions for the pharmaceutical industry and beyond, announced today that Zach Weingarden, MS,…
TrialAssure Releases Comprehensive Guide to Anonymization and Redaction Whitepaper for Free Download
Transparency is no longer optional—it’s expected. As regulations around clinical trial disclosures continue to evolve, organizations are under increasing pressure to protect personal and commercially sensitive data while…
Modernizing Federal Technology for a More Connected and Efficient Government
In a landmark move to improve government operations, the recent Executive Order Establishing and Implementing the President’s Department of Government Efficiency is setting the stage for sweeping changes…
EMA’s New Transparency Rules: Don’t Be Caught Late or in Violation
The European Medicines Agency (EMA) has introduced significant updates to its transparency rules, requiring sponsors and CROs to rethink how they manage clinical trial disclosures. These changes, which…
From EudraCT to CTIS: Clinical Trial Sponsors Need to Prepare Anonymization and Redaction Plans Now
The European clinical trials landscape is undergoing a significant transformation with the transition from EudraCT to the Clinical Trials Information System (CTIS). This shift, driven by the European…
EMA Policy 0070 Relaunch Happening in September 2023: What You Need to Know!
EMA Policy 0070 will be relaunched effective September 2023, as announced by the European Medicines Agency (EMA) during a webinar on Tuesday, May 16, 2023. Now, all Marketing…
Company Confidential Information (CCI) Insights for Anonymization and Redaction in the Pharmaceutical Industry
Company Confidential Information (CCI) and the need to understand what it is and what it is not, is a hotly-debated topic in the pharmaceutical industry, especially in 2023.…