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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…
TrialAssure® – the technology arm of MMS and leading, global software company focused on advancing clinical trial transparency – has won the “Data Solution of the Year—Healthcare” award…
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…
CANTON, Mich. (June 17, 2021) TrialAssure® – a leading, global provider advancing clinical trial disclosure, data sharing, and transparency – has announced the release of TrialAssure LINK software…
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…
The European Medicines Agency (EMA) recently announced the European Union (EU) Portal, a database for obtaining a clinical trial authorization, will be activated by the end of January 2022. The EU Portal will trigger the enforcement of the EU…
For many years, business and IT experts alike have been debating which software selection strategy is better: a single-purpose solution, or an enterprise resource planning (ERP) solution. The…
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…
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…
Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a bi-weekly round-up of some of the key stories. Stories in…
