¿What is a CRO?

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

5 May, 2018

What is a CRO

A CRO (Contract Research Organization) is a company that provides clinical trial management services for the pharmaceutical, biotech, and medical device industries.

Although there are different types of CROs and diverse levels of specialization (distinct therapeutic areas for instance), typical CRO services include regulatory affairs, site selection and activation, recruitment support, clinical monitoring, data management, trial logistics, pharmacovigilance, biostatistics, medical writing, and project management, among others.

In a clinical trial, CROs are hired by sponsors to perform a set of tasks, taking various technical and administrative responsibilities on the sponsor’s behalf.

The main role of the CRO is to plan, coordinate, execute, and supervise the processes involved in the development of a clinical trial, being a central contact point between the sponsor and other trial actors (e.g. ethics committees, regulatory agencies, vendors, and hospitals).

CROs are key players in clinical research, since they have the knowledge and the capabilities needed for the proper development of a clinical study. They help sponsors by reducing their workload, while ensuring trial quality and compliance with national and international standards.

At the same time, many CROs supply innovative technological tools to increase efficiency in the study processes, which translates into cost reductions.

Without doubt, CROs play a crucial role in the success of a clinical trial. Sponsors should carefully assess the particular needs of their projects, and look for the CRO that best meets their technical requirements and budget.

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com