Celebrating 25 Years of Innovation in Biotechnology: Sermes CRO at the Presentation of the Asebio 2023 Report

We attended the presentation of the Asebio 2023 Report, an essential event for the Spanish biotechnology sector. This year is particularly special as Asebio celebrates its 25th anniversary, and at Sermes CRO, we are proud to be part of this ecosystem, having been in the industry for 27 years. The advancements and achievements in this sector are impressive, with collaboration being a crucial pillar

26 days to evaluate your clinical trial thanks to AEMPS’ fast-track assessment

The Spanish Agency for Medicines and Health Products (AEMPS) has implemented a new accelerated assessment procedure for certain clinical trials. This initiative aims to make Spain a more attractive environment for innovative drug research. Below, we explain which trials can take advantage of this fast-track process that reduces the evaluation time from 45 to 26 days

The Essential Role of CROs in Clinical Research

From document management to regulatory strategy, CROs are indispensable partners for the advancement of science and medicine. On Clinical Trials Day, join us on this journey to better understand the vital role that CROs play in the development of innovative treatments and medications.

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.

The CDISC Standards: The Success Formula for Clinical Data

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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

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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.