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
Redaction
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…
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.…
Latest Release of TrialAssure ANONYMIZE for Documents Saves up to 80 Percent of Effort in PDF Document Anonymization and Redaction for Regulated Pharmaceutical Industry Documents
CANTON, Mich. (November 19, 2020) – TrialAssure® has released its latest version of ANONYMIZE for Documents, including the functionality to anonymize and redact PDF documents concurrently. Leveraging the…
FDA Furthers Transparency Push with CSR Release Pilot
The FDA provided insight into their overall vision for clinical trial transparency last week, announcing a new program to publicly release clinical study reports (CSRs) that accompany drug…
This week in transparency news: June 1 – June 7, 2019
Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures…