CLINICAL TRIALS APPROVAL IN EUROPE. APICES EXPERIENCE WITH CTIS
The Clinical Trials Information System (CTIS) is the online system for the regulatory submission, authorization, and supervision of clinical trials in the European Union and the European Economic Area. CTIS is the single entry point for clinical trials in the European Union (EU) and the European Economic Area (EEA).
Besides, CTIS supports interactions between clinical trial sponsors (investigators or companies that run a clinical trial and collect and analyze the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.
CTIS offers searchable clinical trial information to the patient, the healthcare professional, and the public. Clinical trial results are available both as a technical summary and in lay language. Information can be retrieved by searching for a particular trial or across trials for treatment-related details.
Below, the timeline flowchart for clinical trial approval in CTIS is described:
Since the launch of CTIS in January 2021, APICES has managed the approval and transition to CTIS of more than 15 clinical trials.
Remember! All ongoing clinical trials in the European Union (EU) must be transitioned to the Clinical Trials Information System (CTIS) by 30 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU.
Are you running a study that has not yet transitioned to CTIS? At APICES we have broad experience in both transition and approval process of clinical trials in CTIS.
