What is a CRO?

A CRO is a Contract Research Organization. Contract Research Organization is offering its clinical study management services such as Oncology CRO, Ophthalmology CRO, Gastroenterology CRO mainly to the pharmaceutical, biotechnology and medical device manufacturers.

The management of a clinical study is more complicated than it might seem, since many actors are involved (manufacturers, promoters, ethics committees, competent authorities, centers, foundations, researchers, legal departments, patients…).

In addition, it is necessary to work under the standards of Good Clinical Practice and the Harmonization Guidelines (GCP-ICH Guidelines) that ensure the quality of the study. Being able to count on a Contract Research Organization.

As a partner in which to trust the management of the study is essential and in this case the CRO acts as a bridge between the promoter, the one who contracts the services such as Oncology CRO, Ophthalmology CRO, Gastroenterology CRO, and the rest of the actors involved in carrying out the study.

Services Offered by a CRO

Traditionally, a a Contract Research Organization. have been in charge of starting up and monitoring clinical trials as Oncology Clinical Trials, Ophthalmology Clinical Trials, Gastroenterology Clinical Trials, but more and more companies that is offering all the services such as Oncology CRO, Ophthalmology CRO, Gastroenterology CRO, associating with conducting a clinical study are considered “full a Contract Research Organization.service”.

The services that a Contract Research Organization is offering can be divided according to the phase in which we are in the study:

The start-up includes the development and review of applicable protocols, the adaptation of the necessary documentation to legislation, obtaining the necessary approvals from the clinical research ethics committees and the 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 the approval is obtained and the trial begins, the Contract Research Organization. is offering its services such as Oncology CRO, Ophthalmology CRO, Gastroenterology CRO for monitoring, which consists of controlling compliance with the protocol and with the procedures established for the development of the study.

Likewise, pharmacological services include detection and action in the event of the appearance of an Adverse Event.

The last steps to ensure the success of any clinical study are data management, report generation and documentation control and storage. Throughout the study, work is carried out in accordance with Good Clinical Practices (GCP) that ensure the quality of the study.

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Types of CROs

There are different criteria for classify CROs:

• If we take into account the level of specialization of the company, we can find companies specialize in one type of study (clinical trials, research with medical devices or observational studies) and also CROs specialized in a therapeutic area, such as such as Oncology CRO, Ophthalmology CRO, Gastroenterology CRO.

• Taking into account the geographical area in which they operate, we classify CROs as local or global. The global ones are usually large companies that have offices all over the world, their coverage is greater, but they tend to be less flexible than the local ones, whose knowledge of the peculiarities of the country is greater, but their coverage is usually not as wide.

How to Choose a Good CRO

Choosing a good a Contract Research Organization is very important, since much of the success of the study will depending on their management and will helping the trial run as smoothly as possible.

Some of the questions to ask yourself when choosing it are:

• If you are looking for a a Contract Research Organization that can also advise you on the choice of centers, the number of monitoring clinical trials such as Oncology Clinical Trials, Ophthalmology Clinical Trials, Gastroenterology Clinical Trials, and even the size of the necessary sample. In this second case, it is essential to look for an experienced a Contract Research Organization..

• If the way of working adapts to that of the promoter

• If the rates it proposes are adequate and it is providing a clear budget

• If a company committed to the study

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Conclusion

The CROs are a fundamental piece in clinical trials such as Oncology Clinical Trials, Ophthalmology Clinical Trials, Gastroenterology Clinical Trials, that is offering a wide variety of services associated with conducting the study that facilitate the work of the Sponsor.

There are many types of CROs such as Oncology CRO, Ophthalmology CRO, Gastroenterology CRO, so it is essential that we know what we are expecting from them before starting to work together because they will be a key partner in the success of carrying out the study.