Role in drug development

Bringing a new therapeutic to market is a long, complicated and costly process. Research, product development, preclinical studies, and clinical trials involve not only the sponsor's staff, but regulators, physicians, academic researchers, and patients. A company screens through thousands compounds before it could take on a task of a new compound development.

This complex process is broken into several stages (see picture).

Traditionally pharmaceutical companies performed all steps of drug development, but increasingly many perform only the last two steps (Clinical Trials and Post Approval Activities-manufacturing, sales and marketing, and distribution), while delegating the Discovery and Preclinical steps to Contract Research Organizations (“CROs”).

The popularity of CROs was induced by the fact that they enabled pharmaceutical and biomedical companies to save time and expenses due to their specialization in certain stages of drug development. CROs are flexible. They can offer either single-service components or complete development programs allowing their clients to manage product-development efforts more efficiently and cost-effectively.