What is a Contract Research Organization (CRO)?
A Contract Research Organization (CRO) is a company that provides specialized research services on a contract basis for the pharmaceutical, biotechnology, and medical device sectors.
What types of CROs are there?
There are different types of CROs, depending on the specific services they offer. Typically, CROs are segmented in discovery, preclinical, clinical, and laboratory services.
This article focuses on CROs specialized in clinical trial related 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 as “full service”) may offer all the services indicated above, while other CROs specialize in specific tasks only.
What regions do CROs cover?
CROs of different sizes have capabilities to cover more or less territories. There are small CROs focusing on one single country only, while larger companies are able to handle clinical trials in several nations. The largest CROs in the market are considered “global” and can manage big studies across multiple sites and continents.
Why are CROs important in clinical trials?
CROs are important in clinical trials because they assume several specialized tasks that cannot be handled by the clinical trial sponsor. Clinical trials require many overwhelming activities beyond the scope of the sponsor’s know how and resources, so that subcontracting this work becomes the best option.
CROs guarantee the technical proficiency required in clinical studies, ensuring the quality of the research and its results.
What are the advantages of subcontracting a CRO?
By taking care of the numerous demanding operational tasks involved in clinical trials, CROs liberate sponsors to focus on their core business.
In addition, CROs can contribute with key knowledge and contacts that sponsors do not have. For example, due to their experience, local CROs know and can facilitate the names of the best clinical sites and investigators in a specific therapeutic area to ensure high patient enrollment rates.
What kind of staff do CROs have in their teams?
CROs count on highly qualified personnel, normally holding life science related degrees (e.g. pharmacy, biology). The main roles found in CROs include clinical research associates, project managers, clinical trial assistants, heads of clinical operations, regulatory affairs managers, site contract managers, quality managers, data managers, biostatisticians, and statistical programmers, among others.
Are there CROs specialized in specific therapeutic areas?
Yes. Although most CROs manage clinical studies in different diseases, some niche CROs are exclusively focused on a particular therapeutic area. For instance, a CRO can be specialized in managing oncology trials only. This kind of specialization is highly valuable because such CRO will master the ins and outs of cancer trials, giving the sponsor key added value in terms of expertise.
Can multiple CROs be used in a clinical trial?
Yes. Using more than one CRO in the same clinical trial is, in fact, a common practice. The use of multiple CROs is often motivated by the need of service specialization and geographical 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 knowledge. Then, another CRO may be subcontracted to take care of these data-related tasks.
In terms of geographical coverage, the use of more than one CRO is common in large international studies, since a local CRO may be hired to provide service in one particular country while another global CRO leads the project globally.
In any case, the advice for sponsors is to use as less vendors as possible by selecting full service CROs with wide coverage. Dealing with few suppliers simplifies communication and increases efficiency.
How can CROs help in patient recruitment?
CROs are dedicated to managing clinical trials and therefore they have contact with many clinical sites and investigators in a wide variety of therapeutic areas in the countries they operate.
This knowledge is very useful for trial sponsors since CROs can indicate which hospitals and doctors are the best to recruit patients in different populations.
Therefore, CROs play a key role and can make a big difference in ensuring good patient recruitment potential.
Moreover, during the enrollment period of a clinical trial, CROs should be proactive in communicating with sites and doing everything possible to identify candidates to be recruited.
How much do CRO services cost?
Please refer to the article “How Much Does a Clinical Trial Cost?” to obtain cost estimates of CRO services.
How can I choose the most suitable CRO for my clinical trial?
Please refer to the article “How to Select a Clinical Research Organization (CRO)” to get advice on CRO selection.
