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Medical Research Organizations

Clinical Research Organizations or Contract Research Organizations (CRO) are service organizations that specialize in giving support to drug and biomedical industries. They offer out-sourced research services for the development of drugs and medical device tools.

Such organizations must be lawfully registered with trained personnel in the field of expertise. In giving their services, such independent organizations that act as contractors assume the responsibilities of their sponsor.

The pharmaceutical industry is cost intensive with different branches involved. This makes it difficult for one entity to manage and coordinate all its activities under one roof. These in most times made pharmaceutical companies hire contractors to do part of the work involved. This gave rise to CRO's. By outsourcing, the pharmaceutical companies are left to concentrate on their core duties.

CRO's offer varied services, which include;

a. Product development: There might be a need for further development of an existing drug. A CRO can be contracted by the manufacturer of such a drug to carry out the task. The CRO assumes all the responsibilities involved during the whole process.

b. Formulation: Some CRO's are well developed and in a position to formulate drugs and other medical devices. They act as contractors of drug companies for such specific tasks.

c. Manufacturing: Some drug manufacturers are in fact CROs who are specialists in the manufacturing field. They are only given the formulation and they carry out the manufacture.

d. Clinical trials: There exist CRO's whose sole work is to carry out initial clinical trials and thereafter handover to other CRO's whose work is to proceed to the next level.

e. Monitoring: Most CRO's are known to undertake this task. After a drug has been released into the market, the CRO's duty is to monitor its use and any complaints that may arise.

Why Outsource?

There are several reasons why a company may outsource. It has been established that outsourcing has several advantages to drug companies;

a. A drug company may not have a service in-house. Such a company will be forced by circumstances to outsource.

b. The cost of maintaining personnel, expertise and facilities can cheaply be handed over to an outsourced CRO.

c. A drug company may relocate to another country and not being conversant with regulatory and legal issues in that particular country, it will be forced to outsource the services of a CRO in that country.

d. Clinical trials have become complex and time consuming. This can be safely be carried out by an outsourced CRO who have the skill and time to undertake such a task.

e. It is common to find CROs that specifically deal with one area of drug trade. This means that such a CRO has the knowledge, experience and skill in that particular area and it will be prudent to engage its services.

f. Present clinical trials require a large patient population. Managing such a population required may prove a challenge to a drug company. The only way such a company can handle this is through outsourcing.