Sermes CRO strengthens its Quality Assurance activities thanks to the appointment of Dolores Pérez Méndez as its new director. She has developed her career within clinical research, specifically in the area of Advanced Therapies, for 10 years
By Sermes CRO
Dolores Pérez has been working at Sermes CRO since 2018. Her recent appointment as director of the Quality Assurance department comes after her work as head of the company’s Advanced Therapies Unit.
Biologist and immunologist, she is an expert in Spanish and European regulation of clinical trials with advanced therapies. Her advice was crucial for Sermes CRO to collaborate in obtaining the first use authorization for non-industrial manufacturing of an advanced therapy drug in Spain. The NC1 cell therapy, developed by the team of researchers from the Cell Therapy Unit of Hospital Puerta de Hierro, is a pioneering therapy in Europe. It is indicated for the treatment of certain chronic spinal cord injuries and was authorized by the Spanish agency for medicines (AEMPS) in 2019.
Her experience managing clinical trials for pharmaceutical laboratories, biotechnology companies and independent researchers focuses on therapeutic areas such as cell therapy and gene therapy. She is a specialized consultant in the implementation and development of clinical trials with genetically modified organisms.
As director of Sermes CRO’s Quality Assurance department, Dolores Méndez will be in charge of guaranteeing that the processes – external and internal – of the company are developed in a uniform and consistent manner, complying with Good Clinical Practice and all regulatory requirements.
“At Sermes CRO we are totally committed to the quality of research and that is why we take care of each one of the tasks that we develop for our clients. Every year, we audit projects, clinical trials, SOPs, processes and carry out on-site audits”, says Antonio Berlanga, Sermes CRO CEO.