CTIS will be the single-entry point for submitting clinical trial information in the EU. Asphalion, the international scientific and regulatory affairs consultancy company, and a CataloniaBio & HealthTech member, has been part of the EMA CTIS  stakeholder meetings and is also CTIS Master Trainer, thus has been closely involved in the implementation of the clinical trials regulation.

CTIs (Clinical Trial Information System) will go live when the Clinical Trial Regulation (CTR) becomes applicable on January 31st, 2022, and it will repeal the existing Clinical Trial Directive and national legislation that was put in place to implement the Directive. Companies will  have to face many changes regarding CTIS, a unique digital tool for harmonised submission, evaluation, and supervision of clinical trial applications (CTAS) in the European Union, as well as allowing a fully electronic exchange of information between sponsors and Member States over the life cycle of a clinical trial.

“We are proud to have been able to actively participate as a stakeholder in CTIS implementation and be in a position to offer detailed guidance to clients including different levels of training and advice that covers procedures, workflows to map CTIS functionalities and day-to-day use, strategic advice and planning for the transition period and identifying local and transparency requirements”, said Dr Christopher Mann, Scientific and Regulatory Affairs Director of Asphalion.