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
Clinical Disclosure
Dr. Oladayo Oyelola Joins TrialAssure’s Advisory Board to Support Clinical Trial Transparency Strategy
Former Daiichi Sankyo transparency leader brings more than 30 years of experience across pharmaceutical research, clinical development, and global clinical trial disclosure CANTON, Mich. (June 11, 2026) –…
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…
What Sponsors Gain by Embracing the Design for Transparency Concept
In many industries, Design for Quality (DfQ) has long been a guiding framework. It teaches us to build quality into the process rather than inspecting for it later.…
TrialAssure Enhances REGISTRY Platform with AI-Powered Protocol Parsing to Streamline Global Clinical Trial Registration
BOSTON (June 17, 2025) – TrialAssure, a leading technology provider advancing clinical trial transparency, disclosure, and data sharing, announced today a significant upgrade to its REGISTRY platform. For…
Building a Data Sharing Mindset with 5 Steps to Streamline Anonymization Early in Clinical Trials
Anonymization plays a critical role in clinical trial transparency and data sharing in general, but it is often thought of too late in the process. When anonymization planning…
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…
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…