Clinical Trial Regulation: CTIS experts

New EMA’s clinical trials portal (CTIS: Clinical Trial Information System) is about to go live (in January 2022). It sets up new rules and procedures for the assessment and supervision processes for clinical trials throughout the EU. Sermes CRO has been involved in the development of the portal since 2017, as a member of the EMA working group for sponsors and CROs. In addition, we have been certified as “Train of trainers” of the CTIS by the EMA. We are ready to accompany our clients in this transition, which will allow them to reduce time and costs, as well as harmonizing their processes within EU Member States.

Clinical Trial Regulation: CTIS experts

The sooner your organization adapts to CTIS, the sooner you will get the cost reduction it will bring. In addition, it will help you avoid future (complex and expensive) migrations. At Sermes CRO, we have been already working with CTIS for the last five years and are certified by EMA as CTIS Train of trainers. We have set up Sermes CROs CTIS Submission Center (which is currently operating).

CTIS will centralize the submission process for clinical trial applications and the assessment and authorization by Member States in a single unique platform. It will be the single-entry point for submitting, assessing, authorizing, monitoring, and reporting a clinical trial in all EU Member States.

It will include a user management tool to enable access to sponsors, Member States, and the European Commission through dedicated workspaces. It will also provide public with access to clinical trials information.

  • CTIS specialized team
  • In-depth knowledge of European regulations
  • Fluid relationship with the EMA
  • We have been working within the CTIS platform for 5 years
  • Updated SOPs, adapted to CTIS
  • Cost reduction
  • Centralization of all your clinical trials
  • EU-CTR/CTIS quality assurance

 

Contact

If you need more information abour our services

In collaboration with:

Certifications:

Find us: