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Conducting Quantitative Risk Assessments for Anonymized Datasets and Documents: What This Means for Sponsors and Patient Privacy

Conducting Quantitative Risk Assessments for Anonymized Datasets and Documents: What This Means for Sponsors and Patient Privacy

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. ...
Start plain language summaries early or get left behind

Start plain language summaries early or get left behind

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...
FDA Furthers Transparency Push with CSR Release Pilot

FDA Furthers Transparency Push with CSR Release Pilot

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...
Big Improvements in Clinical Trial Transparency Compliance

Big Improvements in Clinical Trial Transparency Compliance

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...

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