Emergence of the CRO Model

The CRO industry first emerged in the late 1970s as the clinical trials process became more regulated by the Food and Drug Administration (FDA). Early CROs helped pharmaceutical companies comply with new FDA guidelines for drug approval. By taking on responsibilities like clinical trial design, patient recruitment, and data management, CROs allowed drug developers to focus on their core competencies. This helped streamline the product development process.

Over the past few decades, the CRO model has gained widespread acceptance in the industry. A major driver of growth has been the desire of pharmaceutical companies to reduce fixed costs and gain more flexible research capabilities. Using CRO partnerships on a project basis allows variable costs that better match research budgets. It also gives drug developers access to specialized expertise and services without having to build extensive in-house resources.

Size and Scope of the U.S. CRO Industry

Today, the U.S. Contract Research Organization  industry has become highly developed with over 1,000 CRO businesses of various sizes. The industry generates over $35 billion in global revenues annually, with the U.S. comprising the largest single market. Leading CRO firms like IQVIA, PRA Health Sciences, and Parexel each generate over $3 billion in annual revenues through their global operations.

In addition to conducting clinical trials, CROs now offer a wide range of drug development services. Many have expanded capabilities in areas like preclinical research, clinical monitoring, biostatistics, safety assessment, and regulatory submission preparation. By outsourcing various research functions, pharmaceutical companies can rely on CROs to efficiently manage entire drug development programs from early research through FDA approval and marketing.

Impact on Clinical Trials

One of the most visible effects of the growing CRO industry has been improved globalization of clinical trials. Leading CROs have established international networks of clinical investigators and research facilities across North America, Europe, Asia, and other regions. This infrastructure allows drug trials to enroll global patient populations more rapidly. It also gives pharmaceutical sponsors access to diverse patient pools needed to evaluate new drugs and treatments targeting global markets.

By taking advantage of time zone differences and variable costs across regions, CROs are able to reduce clinical trial timelines. For example, as patient recruitment winds down in one region, another region's facilities can start enrollment. This type of "rolling recruitment" maximizes the number of patients entering trials each month. Faster and larger trials provide drug developers a competitive edge in quickly evaluating new products.

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