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European Pharmaceutical Contractor

Preparations for the New EU Portal

The EMA is developing a new clinical trial information system (CTIS) that will provide a single portal for submitting and managing clinical trial application (CTA) dossiers, authorisations, and transparency. While this new system is not expected to be live until late in 2020, organisations should be preparing now for the significant process and systems changes that the CTIS will require.

Before a clinical trial can be conducted in the EU, a dossier must be submitted for approval. Once approved, a trial requires the submission of protocol amendments, status updates, and results information after the trial has completed. For trials with paediatric participants, results are required within six months of the end of trial, while trials in adults require results within 12 months.

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About the author

As TrialScope’s Chief Strategy Officer, Thomas Wicks is responsible for the strategy of clinical trial disclosure and transparency solutions. He has more than 20 years of experience with performance and content management solutions, specialising in applications for life sciences such as clinical trial disclosure, structured product labelling, and submissions management. He has been focused on trial transparency since 2007.

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