Clinical Trials play a crucial role in the research and development of medicines. They generate the data regulatory authorities such as the European Medicines Agency (EMA) rely upon when deciding whether a medicine can be allowed on the market in the EU.
EU lawmakers passed the EU Clinical Trial Regulation to boost clinical research in Europe by simplifying the rules for authorising and conducting clinical trials. EMA was given the task of developing the required IT system that would support the modernisation of the processes for authorisation and oversight of clinical trials in the European Union, and the transparency of these trials and their results, foreseen by the Clinical Trial Regulation. This system will provide a single portal for submission and maintenance of clinical trial applications and authorisations, support the coordinated assessment and supervision of the trials by Member States. It will also support the publication of information about these trials, from the point of decision about conduct until the publication of their results.
In the delivery of the IT system, EMA is working with Member States, stakeholders and the IT4U consortium, of which everis is the consortium leader.
Since 2016, IT4U has been providing IT services to EMA, including in the field of pharmacovigilance, where everis has been the lead developer.
Starting May 2018, everis began to lead the development of the safety reporting module of the CT platform and has now fully taken over the development of the EU clinical trials system, meeting all intermediate deadlines with the expected level of quality.
In view of its increased involvement, everis would like to publicly announce its full commitment to EMA and the rest of the stakeholders (EC Member States, Sponsors and all future users of the Clinical Trials platform) in their journey to implement, test and go live with the Clinical Trials platform which will enable the application of the Clinical Trials European regulation.
everis has also been working together with EMA to ensure a smooth transition for the Agency’s relocation to Amsterdam, stressing the importance of achieving seamless business continuity (key personnel and planned activities) regarding the Clinical Trials Programme. As such, everis has established a permanent office in Amsterdam with the aim to secure this continuity of EMA services.
We look forward to working with EMA in the Netherlands to deliver the CT platform with the expected excellent standards and in accordance with the agreed plan.