WebFrom 31 January 2024, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. WebJan 28, 2024 · EU-CTR leverages a new portal and database called the Clinical Trial Information System (CTIS) and enables a centralised, single electronic submission instead of multiple submissions with different dossiers. Sponsors must upload and submit all data, including initial clinical trial application data and documentation, through the CTIS.

The new Clinical Trials Regulation - what you need to know now

WebRecommendation paper on decentralised elements in clinical trials: This recommendation paper (December 2024) was created as part of the priority action 8 ‘Methodology guidances’ of the ACT EU initiative of the Heads of Medicines Agencies, the European Commission and the European Medicines Agency.. The national provision overview is being updated as … WebClinical Trials Insurance Services (CTIS) is a trading name of Howden Insurance Brokers Limited, part of Howden Group Holdings. Howden Insurance Brokers Limited is … porting my number to mint mobile

Clinical Trials in the European Union - EMA

WebThe sponsor workspace in the Clinical Trials Information System (CTIS) assists clinical trial sponsors and other organisations involved in running clinical trials in preparing and … WebThe CTIS is the business tool for the Regulation and will become the single-entry point for clinical trial submission, authorization, and supervision in the EU. The CTIS will allow … WebCTIS for sponsors. Clinical trial sponsors and other organisations involved in running clinical trials can apply to run a trial and can manage an ongoing trial in up to 30 … porting my number to telstra