Clinical Trial Databases: how does the new European regulation CTR 536/2014 affect them?

Databases such as and REec (“Spanish Clinical Trials Register”) are critical to the development and success of clinical trials. They allow the registration and dissemination of ongoing clinical trials and their results, ensuring transparency and accessibility of information. Below, we will analyze to what extent the new regulation 536/2014 will affect them in the coming years and what will happen with EudraCT.

How to register with OMS to be able to work with CTIS?

Blanca Oñoro Sermes CRO Técnica de Documentación Clínica y Terapias Avanzadas en Sermes CRO

To be able to carry out a clinical trial in CTIS, it is previously necessary to be registered with OMS. In this article we explain the OMS registration process for sponsors and sites participating in clinical trials

CTIS, year 2023: a critical moment for clinical trial management in Europe

What changes to expect in January of 2023 regarding the management of clinical trials in Europe? What have we learned in this first year with CTR 536/2014 in force and CTIS in operation? How much time is left until the transition period ends? How much time have the sponsors of clinical trials to adapt to the new situation?

How to manage transitional clinical trials to the new European online portal, CTIS

The European clinical trial regulation establishes a three-year transition period in order to adapt to the new clinical studies’ online portal. In this article you will learn how to manage the transitions of your studies. It is essential that the sponsors and the CROs actively collaborate with each other in the transition strategy regarding CTIS, according to the different phases over the next three years

6 keys to understand the new European clinical trials portal (CTIS)

What changes to expect after CTIS implementation? What about timings and deadlines? What is the scope of CTR and CTIS? Should you set up a strategy for the transition period? Learn how to manage your clinical trials within the new European clinical research scenario reading the article.