Articles
What is a contract research organization?
by Pooja Late so cutThe
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 
so cut
193 connections, 0 recommendations, 600 honor points.Joined APSense since, January 22nd, 2015, From mumbai, India.
Created on Jul 15th 2020 07:12. Viewed 365 times.
