ICH E9 and CDISC: The Master Formula for Excellence in Clinical Research and Data Management
Clinical studies play a key role in the development of new medicinal products and therapies, as well as in evaluating the efficacy and safety of existing medical treatments. To ensure the quality and reliability of the data collected in these studies, it is essential to follow robust guidelines and standards. One of the most important guidelines in this field is ICH E9, published by the International Council on Harmonization (ICH).
Inspiring diversity, transformative inclusion
On the International Day of Persons with Disabilities, December 3, we once again affirm what defines us as an organization: the employment integration of individuals with disabilities, striving for their full integration in terms of employment, social participation, salary, and emotional well-being.
Assessment and approval of clinical trials in CTIS: Theoretical versus actual timelines
Managing clinical trials on the new European clinical trials platform, CTIS, involves taking into account not only the theoretical timelines foreseen in EU CTR 536/2014, but also the actual time it takes for Member States to assess and approve (if applicable) clinical trials submitted via this route.
The CDISC Standards: The Success Formula for Clinical Data
In the world of clinical research, data exchange and analysis play a key role in the development of safe and effective treatments. The Clinical Data Interchange Standards Consortium (CDISC) have proven to be the formula for success in achieving effective harmonization and standardization in clinical data exchange. In this article, we will explore how CDISC standards have revolutionized the way data is presented, analyzed and shared in medical research, improving the quality of clinical trials and accelerating progress towards new therapeutic advances.
Payment of clinical trial fees: news and exemptions
Find out about the five cases that are exempt from paying fees to conduct clinical trials, following legislative changes affecting fees on medicinal products, medical devices, cosmetic products, and personal care products.
Julio Bonis, appointed as Artificial Intelligence & Big Data director at Sermes CRO
Menú Home Servicios Expertos en CTIS y la regulación europea de ensayos clínicos Full Service CRO Terapias Avanzadas Soluciones de Inteligencia Artificial Soluciones Tecnológicas personalizadas Soporte personal Patient Centric Unit Quiénes somos Blog Talento Contacto Idiomas Our Blog Julio Bonis, appointed as Artificial Intelligence & Big Data director at Sermes CRO We strengthen our Artificial […]
Analysis of Express Import Authorizations for medical devices
In exceptional circumstances, healthcare professionals may be faced with the need to use medical devices that have not obtained the CE marking or are to be used under conditions other than those authorized. In this article, we will analyze express authorizations for the import of medical devices, the legislation applicable to them and the documentation required to apply for them.
Bravo for diversity!
In the LGTBI pride week we want to state, once again, what defines us as an organization: at Sermes CRO we are a company with a soul, a company in which the human – and social – component have a main weight. When we say “bravo for diversity” it’s not just words. We are talking about facts. Do you want to know why?
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