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.
We are analyzing the EU CTR and the CTIS at the OCT Europe 2023 congress
Raquel Reviejo, EU Regional Submission Lead at MSD, and Lidya Domínguez, Clinical Research Director at Sermes CRO, will analyze the changes arising from the new European clinical trial platform, CTIS, at the Outsourcing In Clinical Trials Europe 2023 congress. The conference will take place in Barcelona on May 3rd and 4th.
European Patients’ Rights Day
On April 18th we celebrate the European Patients’ Rights Day. The aim is to inform, discuss, and take commitments to improve patients’ rights in Europe and in each Member State
Nominal variables are more than just a name
The analysis of nominal variables is very common in clinical trials. If you want to know more about how to analyze these types of variables, continue reading!
José Alberto Catalá Hernansáiz, new CISO of Sermes CRO
We strengthen our information security management with the appointment as CISO (Chief Information Security Officer) of José Alberto Catalá Hernansáiz, whose professional career has been linked to information technologies for 28 years, and to IT security-related positions for the last 5 years
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
MSD grants Sermes CRO its Diversity Award 2022
MSD rewards Sermes CRO’s diversity in its “Power of Inclusion Awards 2022”, in the disability category. The global pharmaceutical company Merck Sharp & Dohme selects us among all its vendors as the company that best represents the values of diversity and disability care
Survival Analysis Done Wisely
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?
“Advanced Therapies are the medicine of the future”: Mercedes Zurita, researcher and head of the Cell Therapy Unit at Puerta de Hierro Hospital
We interviewed Dr. Mercedes Zurita, researcher at the Puerta de Hierro Hospital and head of the Cell Therapy Unit at this site, the only one in Spain to offer NC1 therapy for patients with spinal cord injury. This novel treatment is the result of a long and successful research in which Sermes CRO has done its bit by contributing during the development of the entire clinical phase and by providing initial funding through the Sermes Foundation for Clinical Research