Clinical Trial Databases: how does the new European regulation CTR 536/2014 affect them?
Databases such as ClinicalTrials.gov 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?
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?
Are we making the most of the new European clinical trials platform, CTIS?
We analyze the usage data of the CTIS in its first three months of operation and we present you the new report that the EMA will publish periodically with the main KPIs. It comprehensively monitors the European clinical trial ecosystem.
Conference in Madrid: “CTIS: full application of the European regulation of clinical trials”
The experts participating in our conference agreed to value the CTIS as a tool that will be very useful for the management of clinical trials in Europe, by harmonizing the requirements among different countries and centralizing documentation management
Sermes CRO, first company to manage the submission of a clinical trial in Spain through CTIS
Sermes CRO, together with Mikrobiomik, manages the first submission of a clinical trial in Spain through CTIS (Clinical Trial Information System), the new European clinical trial’s portal.
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.
EMA certifies Sermes CRO as a key entity in the CTIS Training plan
Sermes CRO has been elected by the EMA as “Train of trainers” for the new Clinical Trial portal, CTIS (Information System).
