Definitions of Clinical Research Terminology

Contract Research Organization (CRO)

A contract research organization, clinical research organization, clinical research organisation, contract research organisation, or CRO such as Emissary International is a company or organization contracted by a pharmaceutical, medical device, or biotechnology company (called a clinical trial sponsor) to assume various aspects of the clinical research process (i.e., to conduct clinical research trials on behalf of the sponsor). Contract research organizations employ various clinical research associates (CRA), biostatisticians, medical writers, project managers, and similar clinical research professionals to support the conduct of clinical trials on behalf of their pharmaceutical, biotech, and medical device company sponsors.

For example, a clinical research organization may assume responsibility for reviewing and validating (called monitoring) the clinical trial data collected by a clinical investigator (a medical professional, usually a physician, who enrolls the study patient and administers the investigational drug or medical device) during a clinical trial. Other CRO services usually include medical writing, regulatory support, investigator selection and qualification, clinical trial management, and data analysis (biostatistics).

A contract research organisation is typically a for-profit commercial operation; some non-profit organizations (such as some large academic medical centers) may operate like a contract research organization, but this is typically through a separate for-profit entity. Clinical investigators themselves, which are hired by the CRO or the sponsor directly to actually conduct the clinical trial at a specific location, may be part of an organization that provides CRO-like services or that provides joint marketing and clinical trial support. These are often termed site management organizations (SMO) or trial managment organizations (TMO) or clinical research coordinating centers (CRC)  to distinguish them from more traditional contract research organizations.

Worldwide, there are about 1,100 companies operating in the contract research organization industry, including a number of individuals working as independent consultants. Only a few hundred CROs have sales exceeding $10 million (USD), and of these only about a dozen are publicly traded. Most of the largest contract research organizations have operations in multiple countries to support the conduct of international clinical trials. The 5 largest CROs control about 45% of the worldwide market.

In an attempt to continue their rapid growth, some of the larger contract research organizations have expanded into other fields such as medical product marketing (pharmaceutical detailing), discovery and formulation, contract manufacturing, clinical labs, and other related fields. Such companies closely resemble a pharmaceutical company, and if fact, several have begun developing products for themselves, in some respects actually competing with their clients.

The contract research organization industry is relatively young. Most of the top CRO industry participants were founded in the late 1980's to mid 1990's as the pharmaceutical industry first began to recognize outsourcing as an effective cost-reduction strategy. Estimates of the industry's size are difficult given that most CROs including some of the largest are privately held. Also, as discussed above, some CROs, particularly the larger ones, generate income (often a majority of their sales) from activities other than clinical research, and CRO industry analysts often differ in precisely what outsourced-service providers should be included (i.e., among pure-play CROs, labs, site management organizations, clinical sites, specialized staffing companies, drug packaging, clinical research software vendors, etc.). A May 2007 analysis by Business Insights estimated the global market for outsourced pharmaceutical support services at $14 billion (USD) and growing at 15% annually to reach $24 billion by 2010, but this report includes revenues unrelated to clinical trials. A more specific, albeit somewhat older, 2003 analysis of the worldwide contract research organization industry estimated the market for outsourced clinical development services at around $6 billion and growing at low double-digit rates.

Data collected in the CROCAS database of industry-reported contracts awarded to contract research organizations shows the percentage of contracts for CRO services that is awarded to smaller contract research organizations has consistently remained at 50% or higher since 1997. Smaller CROs such as Emissary International typically provide greater responsiveness and more in-depth therapeutic expertise than the larger CROs, who are more typically focused on continuous acquisitions and aggressive sales practices necessary to meet the demands of the stock market and short-term focused investors.

In a 2000 CenterWatch survey, 82% of pharmaceutical companies reported that they expected to use smaller, specialized CROs alone or in combination with the large CROs. The Bio/Pharmaceutical Outsourcing Report newsletter in the same year estimated that 45% of pharmaceutical companies would be spending more with smaller CROs in the coming years.

Emerging clinical trial software technologies such as electronic data capture (EDC) have allowed the smaller CROs to compete more effectively, where before maintaining an expensive staff-intensive traditional data management capability often presented a competitive barrier. Smaller CROs have been better at exploiting EDC as they do not risk losing a profitable data entry business that has previously been the mainstay of the large full-service CROs, nor do they have resistance from large and firmly-entrenched data management departments and the need to recoup millions of investment in archaic data entry platforms. Thus, the trends support a continuation of the role of the smaller CRO in the clinical outsourcing of pharmaceutical and medical device R&D.