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Clinical Trial Regulation

CTR enables swift EU clinical trial authorizations, as only one collated clinical trial application for all EMA countries is needed.

NNIT has already supported several pharma companies in the journey to CTR implementation. Based on our experience, we can help in analyzing the processes as well as technology update needs of your company in order to ensure a smooth transition into CTR and the upcoming use of the EU portal.

The clinical trial regulation (CTR) provides a new process for CTA submission to health authorities and ethics committees. With this regulation, it is possible for pharmaceutical companies to submit only one collated clinical trial application for all EMA countries per trial. Therefore, the CTR enables swift EU clinical trial authorizations.

 Companies have an opportunity to:

  • Save resources in a clinical trial start up
  • Optimize the systems and processes affected by CTR. 

One collated clinical trial application for all EU countries must be made in the coming EU portal. The EU portal will be used for trial application purposes, publishing trial documents to create more transparency, and reporting of a number of trial milestones.

These include milestones such as "end of trial, inspection reports, interim analysis reports, serious breaches, and temporary halt" as well as various other new and familiar milestones. 

This CTR implementation, and new processes and roles may be the appropriate next step for your company. This is also a great opportunity to review and improve the current working processes, including the processes for document collection and preparation for submissions to the EU portal.

NNIT CTR Transition Methodology:

 

Download our presentation on CTR here.

 

 

Rune Bergendorff+45 3075 1747 rrb@nnit.comManaging Consultant - Life Sciences Advisoryhttps://dk.linkedin.com/in/rune-bergendorff-5160272bRune Bergendorff

 

 

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