Based on our strong CTIS expertise, we are an experienced partner for submission in new Europe’s Clinical Trials scenario.

CTIS will be the single-entry point for submitting, assessing, authorising, supervising and reporting a clinical trial in all Member States of the EU.

The system is currently under development, with PSNResearch as member of the working group since 2017, and will have collaboration and communication tools, workflow and document management capabilities.

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

CTIS will centralise the submission process for clinical trial applications and the assessment and authorisation by Member States in a single unique platform.

These are CTIS new features:

  • Single entry point for EU Clinical Trials
  • User registration and roles
  • PART I: Same documentation to be submitted within EU member countries: ONE SUBMISSION — ONE AUTHORISATION
  • PART II: Similar documentation to be presented within EU member countries: ONE SUBMISSION — SEVERAL AUTHORISATIONS (one per country)
  • SUPERVISION OF CLINICAL TRIALS: Task/notification throughout lifecycle of the CT: WELCOME CTIS NOTICES AND ALERTS, BYE-BYE EMAILS…
  • SAME REQUIREMENTS AND DEADLINES  in all EU member countries

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 PSNResearch, we have been already working with CTIS for the last five years and are certified by EMA as CTIS Master Trainer.

  • Specialized team
  • Strong knowledge of European regulation
  • Present engagement with EMA
  • Previous exposure to CTIS
  • Updated SOP’s
  • Cost effectiveness
  • Centralization of all your CT