by Olivia Grant | Oct 3, 2022 | Blog
CANTON, Mich. (10/2/2022) – Data anonymization and document anonymization in clinical trial data is now more important than ever. In recent years, clinical trial data sharing has become a requirement as part of the regulatory process for EMA and Health Canada. ...
by curtis@digitalliance.com | May 10, 2018 | Blog
In July 2019, the European Union (EU) Clinical Trial Regulation No. 536/2014 will go into effect, requiring all sponsors, including academia, conducting clinical trials to draft lay or plain language summaries for phase 2-4 clinical trials. These lay summaries need to...
by curtis@digitalliance.com | Jan 30, 2018 | Blog
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 approval submissions. They plan to pilot nine recently-approved drugs (yet to...
by curtis@digitalliance.com | Jan 18, 2018 | Blog
Bioethics International recently published their second, long-promised Good Pharma Scorecard, a ranking of large biopharmaceutical companies’ compliance with disclosing data for new medicines to public registries, in BMJ Open. With this recent publication, a spotlight...