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About Clinical Research

The clinical research industry is a highly regulated and complex branch of the health sector that investigates and ensures the safety and effectiveness of new medical treatments, interventions, and devices.

When biotechnology or pharmaceutical companies have a new medical intervention or a want their product to be approved for treatment of a new indication, there is a long process they have to go through before that product is approved to be put on the market. They have to prove to the world’s regulatory agencies that their product does what it says it will and is safe for patients. This process is rigorous, so much so that in the US, less than 15% of trials that start ever make it to final approval. (Which is why we take such pride in being involved in more than 100 approvals in our 20 year history.)

The Clinical Trial Process

Before a new treatment ever comes near a human, it first has to go through a series of tests in a laboratory setting. The results of that testing must be then be provided to the appropriate regulatory agencies in order to obtain permission to begin clinical testing in humans. Once it receives approval, it can then enter the clinical trial process. This process is complicated, and isn’t necessarily a straightforward path. (Fun fact, the purpose of the looping arrow in CTI’s logo is to illustrate how we can move through the many twists and turns of the clinical process and always continue to move onward and upward.)

In general, however, a clinical trial typically goes through the following steps (or as we call them in the industry, “phases”) intended to discover the answers to specific kinds of questions in the safest order*:

  • Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.
  • Phase II trials: The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety.
  • Phase III trials: The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.
  • Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and optimal use.

*Source: NIH 

What is a CRO?

A contract research organization (CRO) is an organization hired by the sponsor of a clinical trial to manage some or all aspects of the trial. CTI is a full-service contract research organization, which means we offer our sponsors support for all aspects of the trial. We can help them set up the trial for success from the very beginning, manage the day-to-day aspects of recruiting for and monitoring a trial as it is in process, help them with dealing with regulatory agencies around the world, write articles about the trial for publication, and so much more.

What kinds of job are available at a CRO?

As with any organization, a CRO needs people to work in a variety of different departments. We look for talented finance professionals, experienced nurses, innovative IT speciallists, seasoned physicians, accomplished admins, detail-oriented project managers, and many other kinds of professionals to help make our team as successful and efficient as possible. Browse through all of the positions we currently have open to see if one of them fits with your background!

 

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