VIDEO: How to customize replacement text
TrialAssure ANONYMIZE® enables rapid, accurate data and document anonymization and redaction, and one common question that we receive from users is “how do I customize replacement text?” To…
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Transparent Thinking.
Working notes on clinical trial transparency since 2012 — disclosure, anonymization, and AI-assisted writing, by the people who do the work.
VIDEO: How to configure rules for dates
TrialAssure ANONYMIZE® is the data, document, and image anonymization and redaction technology that empowers you to share information with confidence, knowing that patient and company confidentiality are protected.…
VIDEO: How to configure common rule types
TrialAssure ANONYMIZE® employs powerful machine learning to enable you to redact or anonymize unstructured clinical documents, structured datasets, and medical images. And, one of the common questions that…
Health Canada guidelines for clinical trial registration and results posting to be released
This winter, new draft Health Canada guidelines for clinical trial registration and results posting will be released. At a time when industry-wide transparency efforts are increasingly focused on…
How to Solve Challenges in Plain Language Summary Writing
By: Michelle Reed, Associate Manager of Regulatory and Medical Writing Plain language summary (PLS) writers take highly technical and scientific language and translate it into common language so…
Data Anonymization Techniques in a Clinical Trial
“Originally published on TrialSite News on June 28, 2021” Clinical trial transparency is quickly emerging as a critical function within sponsor and academic organizations, as its importance in the pharmaceutical, biotechnology, and medical…
How to Train Users on the Clinical Trial Information System (CTIS) Ahead of New Regulations.
On 31 July 2021, the European Commission published a notice in the Official Journal of the European Union announcing that the EU Portal and Database, a key component of the Clinical Trial…
Attention Sponsors, Be Prepared to Publish Your Interim Clinical Study Results
Right now, imagining that Sponsors would be required to publish the results of their interim analysis before the end of the study seems impossible. However, this will eventually become an obligation In Europe starting in January 2022. Posting the interim results will be a revolution…
EU Clinical Trials Regulation: The Need for Coordination by Sponsors
Planning, timing, and coordination. These three words may be the magic formula that Sponsors will have to adopt when the European Clinical Trials Regulation comes into force. Sponsors will have to prepare their timelines well to prevent enduring disappointments or ultimately delaying the start of a clinical…
Ultimate Guide for Creating Effective Plain Language (Lay) Summary Graphics
Including simple, well-designed graphics in a plain language (lay) summary (PLS) can enhance the reader’s understanding of the technical aspects of a clinical trial. Graphics increase the readability…