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May 10th, 2024

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.

By Sermes Cro


CROs (Contract Research Organizations) are service companies that play a fundamental role in the world of clinical research. These organizations work closely with clinical study sponsors: pharmaceutical, biotechnological and medical device companies, as well as independent researchers and research groups.

Clinical trial sponsors rely on CROs to carry out a whole series of non-clinical but equally essential tasks for their objective. This includes the management of documentation and regulatory strategy, two crucial aspects to obtain the necessary authorizations from regulatory agencies, such as the AEMPS (Spanish Agency for Medicines and Health Products) and the EMA (European Medicines Agency).

CROs offer a wide range of services, such as clinical research and consulting, biostatistics, data management, pharmacovigilance, quality control, patient recruitment, and services related to the TMF (Trial Master File) document archive. Each of these services is essential to ensure the success and quality of clinical research.

In addition, CROs can be classified according to their geographical location and specialties. Some CROs are local, focusing their business mainly in the area where they are located, while others have a global presence. As for specialties, some CROs focus on specific types of studies, such as clinical trials, observational studies, or research related to health products. Others specialize in a specific therapeutic area, such as oncology, hematology, cardiovascular diseases, nervous system pathologies, or respiratory system.

Therefore, CROs are key players in clinical research. Through the multiple services they offer, they work to achieve the highest quality in the development of clinical trials.


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