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The Informa Clinical Data Disclosure event in Philadelphia this year brought numerous conversations on Company Confidential Information (CCI) to the forefront. For biopharmaceutical companies, protecting proprietary information and…
EMA Policy 0070 will be relaunched effective September 2023, as announced by the European Medicines Agency (EMA) during a webinar on Tuesday, May 16, 2023. Now, all Marketing…
The Clinical Data Disclosure, Transparency & Plain Language Summaries Conference just wrapped for 2023, bringing key decision makers in the pharmaceutical transparency space together at the Hilton at…
Artificial intelligence (AI) in the pharmaceutical industry is growing as “the global artificial intelligence market size was valued at USD 136.55 billion in 2022 and is projected to…
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…
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…
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…
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…
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…
