by Avery Zimmerman | Jan 4, 2023 | Blog
The Clinical Trials Information System (CTIS) is a single portal for European Union (EU) competent authority and ethics submissions for clinical trial applications (CTAs) across EU member states. The system represents the actualization of the EU Clinical Trials...
by Avery Zimmerman | Nov 30, 2022 | Blog
With all new regulations like Health Canada-PRCI, EMA Policy 0070 and EU-CTR requiring the publication of clinical information, it’s important to understand what is considered company confidential information (CCI) and how to protect the information being shared with...
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 Avery Zimmerman | Sep 15, 2022 | Blog
On 31 January 2022, the EU Clinical Trial Regulation 536/2014 (commonly known as EU-CTR) replaced the long-standing directive, the European Union (EU) Clinical Trial Directive 2001/20/EC (commonly known as EU‑CTD). There are important changes in the EU-CTR, compared...
by Avery Zimmerman | Jul 29, 2022 | Blog
As regulations around clinical trial data disclosure continue to increase in complexity, it can be difficult to keep up with the changes. We asked Raina Agarwal, Associate Director of Clinical Trial Disclosure, to give us a class in Clinical Trials 101 to go over the...
