Articles

What is a contract research organization?

by Pooja Late so cut

The manufacture of drugs and pharmaceutical items involves so many stages and steps. Pharmaceutical companies don’t just proceed to making drugs without conducting a study or research. They carefully analyze the impact the drug would have on the potential users before the production and manufacture commences. Often times, the pharmaceutical company involved in the production of the drug does not carry out a research by themselves. Many of them outsource this task to a third-party company. The companies and agencies that carry out these tasks are known as contract research organizations.

A contract research organization does not only serve pharmaceutical and drug producing companies. They offer their services to biotechnology companies, government agencies and institutions, universities and institutes of learning, as well as companies that specialize in the production of medical devices.

Pharmaceutical companies are constantly looking for ways to outsource tasks that are capable of slowing down their operations and productivity. Usually, they outsource their manufacturing tasks to contract manufacturing organizations. Also, they outsource their research functions to contract research organizations. Pharmaceutical companies collaborate with contract research institutes to perform clinical trials of drugs and for the manufacture of new drugs.

Contract research organizations are usually in charge of the management and supervision of another company’s functions, trials, and duties. When a company agrees to work with a contract research organization, they are not compelled to higher their staff or employees. The major goal of working with a CRO is to reduce the amount of time and resources spent on conducting clinical trials. It has been established that it takes a longer time to conduct such trials in-house than it takes when it is outsourced to a contract research organization.

Parts of the research these companies conduct include bioequivalence study. The aim of conducting bioequivalence study is to measure the closeness and similarity between two drugs or formulations. It is also a way of comparing a formulation to a particular drug. By working with a contract research organization, a pharmaceutical company will be able to cut cost significantly. This is because they wouldn’t need the infrastructure or manpower that would have been used to conduct meaningful research.

The CRO handles all aspects of clinical trial of a drug or medicine. For clinical trial to be conducted a site must be selected and patients have to be enrolled. Any contract research organization that agrees to work with you will take up these responsibilities. They are also saddled with the responsibility of obtaining approval from the appropriate food and drug regulatory body.

While it is the responsibility of the contract research organization to ensure quality trials and research are carried out, the onus is on the sponsor of the trial to provide reliable and accurate data and figures. The accuracy and precision of the data provided will ultimately decide the direction the clinical trial and research will go.

Do contract research organizations do other things?

Most contract research organizations do more than research and trials for sponsor companies. Many of them engage in quality and metric reporting, management of projects, summary of safety and efficacy of a process, validation of data, data entry, management of data from clinical trial of a drug, report writing, analysis of statistics, design of database, and a few other operations. 


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About Pooja Late Senior   so cut

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Joined APSense since, January 22nd, 2015, From mumbai, India.

Created on Jul 15th 2020 07:12. Viewed 160 times.

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