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Managing the New EU Clinical Trials Regulation 536/2014 – Guidance for Navigating the Clinical Trial Information System (CTIS)
Staying on top of global regulatory guidelines and compliance is challenging for every organization working in the clinical research industry. Leaders from THREAD recently attended a comprehensive training session around the new Clinical Trial Regulation 536/2014 held by the European Medicines Agency (EMA) in order to help our global customers effectively navigate the changes associated with the new guidelines.
Understanding and Navigating Changes to EU Clinical Trial Regulations – Guidance from THREAD
A major change to clinical trial regulations (CTR) in the European Union (EU) will be implemented in early 2022. A significant regulatory revision will go into effect as the Clinical Trial Regulation (CTR) No. 536/2014 EU will become the new standard by which clinical trials in the EU must be conducted.
How to Navigate the Global DCT Landscape
One of the benefits of running a decentralized clinical trial (DCT) is its scalability on a global level. Global adaptation of decentralized clinical trials allows sponsors and CROs to maximize operational efficiency, engage with a wide swath of participants and improve study outcomes