What is a Contract Research Organization (CRO)?

A contract research organization (CRO) is a company that provides specialized research services on a contract basis to the pharmaceutical, biotechnology and medical sectors.

What types of CROs are there?

There are different types of CROs depending on the specific services they offer. Typically, CROs are divided into research, preclinical, clinical, and laboratory services.

This article focuses on CROs specializing in clinical trial activities.

What clinical trial services do CROs offer?

The main clinical trial services offered by CROs are regulatory affairs, site selection and activation, site management, monitoring, data management, logistics management, pharmacovigilance, biostatistics, medical writing and project management.

Some CROs (considered “full service”) may offer all of the above services, while other CROs only specialize in specific tasks.

What regions do CROs cover?

CROs of different sizes have the ability to cover more or less territory. There are small CROs that only focus on one country, while larger companies are able to conduct clinical trials in several countries. The largest CROs in the market are considered "global" and can manage large studies in different locations and continents.

Why are CROs important in clinical trials?

CROs are important in clinical trials because they take on several specialized tasks that cannot be handled by a clinical trial sponsor. Clinical trials require many overwhelming activities beyond the know-how and resources of the sponsor, so subcontracting this work has become the best option.

CROs guarantee the technical expertise required in clinical trials and ensure the quality of research and its results.

What are the benefits of subcontracting a CRO?

By taking care of the many demanding operational tasks associated with clinical trials, CROs free sponsors to focus on their core business.

In addition, CROs can contribute key knowledge and contacts that sponsors do not have. For example, through their experience, local CROs know and can convey the names of the best clinical sites and investigators in a particular therapeutic area to ensure high patient enrollment rates.

What kind of employees do CROs have on their teams?

CROs count on highly qualified personnel who typically have degrees related to the life sciences (eg, pharmacy, biology). Major roles in CROs include clinical research associates, project managers, clinical trial assistants, clinical operations managers, regulatory affairs managers, site contract managers, quality managers, data managers, biostatisticians, and statistical programmers, among others.

Are there CROs specializing in specific therapeutic areas?

Yes. Although most CROs manage clinical trials in a variety of diseases, some specialized CROs focus exclusively on a particular therapeutic area. For example, a CRO may specialize only in the management of oncology trials. This kind of specialization is very valuable because such a CRO can handle all the details of cancer studies, giving the sponsor a key added value in terms of expertise.

Can multiple CROs be used in a clinical trial?

Yes. In fact, it is common practice to use more than one CRO in the same clinical trial. The use of multiple CROs is often motivated by the need for service specialization and geographic coverage.

A trial sponsor may have hired a CRO with strong capabilities in start-up, regulatory and monitoring activities, but lacking data management and biostatistical expertise. Another CRO can then be outsourced to handle these data-related tasks.

In terms of geographic coverage, the use of more than one CRO is common in large international studies, as a local CRO may be hired to provide services in one specific country while another global CRO leads the project globally.

In any case, the advice for sponsors is to use as few vendors as possible by choosing a full service CRO with broad coverage. Dealing with several suppliers simplifies communication and increases efficiency.

How can CROs help with patient recruitment?

CROs are involved in the management of clinical trials and therefore have contact with many clinical sites and investigators in a wide range of therapeutic areas in the countries where they operate.

This knowledge is very useful for trial sponsors, as CROs can indicate which hospitals and physicians are best for recruiting patients in different populations.

CROs therefore play a key role and can significantly contribute to ensuring good patient recruitment potential.

In addition, CROs should be proactive in communicating with sites during the clinical trial enrollment period and do their best to identify candidates for admission.

How much do CRO services cost?

Please read the article “How much does a clinical trial cost? get cost estimates for CRO services.

How can I choose the most appropriate CRO for my clinical trial?

For information on choosing a CRO, see the article "How to Choose a Clinical Research Organization (CRO)".

Also read:- Facts About A CRO