Contract Research Organization ¬¬– A Guide to Clinical Research Development

A contract research organization (CRO) provides services to a number of companies which deal in pharmaceutical, biotechnology, healthcare and medical equipments. It is also known by the name of Clinical research organization. A CRO provides services for examining and auditing the clinical data which is collected by a medical professional or a physician. Pharmaceutical companies have begun outsourcing data management, medical coding and database development.

Outsourcing in Clinical Research
Outsourcing has always been very significant in the pharmaceutical and health care industries as the overall achievement of a pharmaceutical company is dependent on the capability in various fields such as computer integrated manufacturing, combinatorial chemistry and advertising medicines to consumers. The theory of outsourcing an exacting operation to a contract research organization is referred as Functional Sourcing. The outsourcing market is progressed in answer to the upward and downward cost pressures put forth on pharmaceutical manufacturer’s profit margins. As Such this pressure has the potential of increasing in future; CROs will become imperative strategic partners for pharmaceutical companies.

Growth and Market of CROs
The industry of contract research organizations is one of the fastest growing industries and emerged in 1990s when the pharmaceutical research & development hard work became more difficult and the competition in fast mounting therapeutic areas augmented. There are approximately 1100 companies which operate in this industry worldwide. The CROs range from large, international full service organizations to small, niche specialty groups. A few hundred CROs get sales up to $10 million USD. Many CROs have established themselves in various countries to empower the market of international clinical trials. The five largest CROs control nearly 45% of the global market. A huge amount of Research and Development budget is applied for outsourcing facilities and services provided by the CRO industry. This is estimated to rise at 15% in the next three years and hence it must boost more with the expansion of the range of services which are outsourced to wrap the complete value chain. To attain rapid growth, some of the large CROs have broadened their services in clinical labs, medical product marketing, contract manufacturing and other fields. The CROs employ medical writers, Clinical research associates (CRA) and healthcare research professionals.

Growth of Small CROs
With the Emergence of the clinical trial software like EDC (electronic data capture) many small scale CROs have started to better manage an experienced staff, as it comes with huge expenses. They are able to make the optimum use of Electronic data capture software and do not face the risk of losing a profit making data entry business which was the main strength of larger contract research organizations. This gave way to the smaller CROs to outshine and achieve more profits in the healthcare and pharmaceutical research and development.