RESOURCES
Working notes on clinical trial transparency since 2012 — disclosure, anonymization, and AI-assisted writing, by the people who do the work.
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 the first time in US history, the FDA has taken action against a clinical trial Sponsor for non-compliance with ClinicalTrials.gov requirements. After a Pre-Notice of Noncompliance, the…
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…
When customers are not happy with a vendor, 91% of the time they decide not to work with that organization again. IT vendors and suppliers should take note,…
Although penalties for Responsible Parties who failed to comply with clinical trial registration or results submission requirements were written into FDAAA 801, these penalties, in the form of…
Start drafting plain language summaries (lay summaries) now or get left behind. Dowload this free resources to learn more.
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…
Knowing where to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial data…
Knowing where to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial data…
Knowing where to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry…
