The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and collab orative. The EU CTR aims to harmonise clinical trial applications in the EU, bring more innovation to Europe, and enable faster approval of clinical trials. However, the novel process of clinical trial application in its early stages is fraught with technical and logistic challenges.