PHARMACIST STEVE

A cro is a clinical research organization by contract. It is a type of company that offers its clinical studies management services to the pharmaceutical, biotechnology, and medical device manufacturers mainly. The management of a clinical study is more complicated than it might seem since many actors are involved (manufacturers, promoters, ethical committees, competent authorities, Centers, Foundations, Researchers, legal departments, patients). Also, they must work under the rules of Good Clinical Practice and the Harmonization Guidelines (GCP-ICH Guidelines) that ensure the quality of the study. Being able to have a CRO as a partner to rely on the management of the study is essential and in this case, the clinical research organization by contract acts as a bridge between the promoter, the one who hires the services, and the rest of the actors involved in the clinical study.

Services offered by a CRO:

Traditionally, CROs have been responsible for the implementation and monitoring of clinical trials, but more and more companies that offer all the services associated with conducting a clinical study are considered “full-service CROs.” The services that a CRO can offer can be divided according to the phase in which you are in the study:

• The implementation includes the development and review of protocols for trials, the adaptation of the necessary documentation to the legislation, the obtaining of the necessary approvals from the clinical research ethics committees and regulatory authorities, the design and the preparation of the data collection notebooks, the determination of the sample, the selection of the best researchers and research centers and the final negotiation of the contracts.
• Once approval is approved and the trial begins, the clinical research organization by contract offers its services for monitoring, which consists of monitoring compliance with the protocol and with the procedures established for the development of the study. Likewise, pharmacy vigilance services include detection and action in case of the occurrence of an Adverse Event.
• The last steps to ensure the success of any clinical study are the management of data, the generation of reports and the control and storage of documentation. Throughout the study, work is carried out by Good Clinical Practices (BPC) that ensures the quality of the study.

 Types of CROs

There are different criteria to classify CROs:

• If you take into account the level of specialization of the company, you can find companies specialized in a type of study (clinical trials, research with health products or observational studies) and also CROs specialized in a therapeutic area, such as oncology or ophthalmology.
• Taking into account the geographical area in which they move, you can classify CROs as local or global. Global companies are usually large companies that have offices all over the world, their coverage is greater, but they are usually less flexible than local ones, whose knowledge of the country’s peculiarities is greater, but their coverage is usually not as wide.

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