What is a CRO in Clinical Trials?

When it comes to coming up with a new drug, treatment, or way of handling any ailment or trauma, testing the waters first is essential for preventing the new drug from having exactly the opposite effect of the initially intended one. 

Now, clinical trials often take a long time for well-justified reasons. 

Rather than giving someone a drug that’s not been tested properly and hoping for the best, having clear proof of what the drug can and cannot do before administering it can save lives. 

What is certain in making new drugs is that you need to have your invention tested. On the other hand, how you get the drug tested and eventually approved is up to you. 

This is where CROs (contract research organizations) come in. 

Rather than having a massive and expensive team of medical and pharmaceutical experts onboard your company at all times, CROs help you outsource some of the research to a third-party organization. 

This article will discuss CRO in clinical trials and how it can bring fresh air to them through speed, expertise, and cost. 

What is a CRO? 

A CRO represents a company that provides various services related to clinical trials. 

The job of a CRO can include pre-clinical research, where a drug is first tested on animals. Alternatively, you can hire a CRO to participate in the actual clinical trials, where their team’s expertise and size can help speed up the process and ensure adherence to rigorous medical testing standards. 

Last but not least, a part of a CRO’s job can be to monitor and assess the post-marketing performance of a drug that’s already been released. 

In 2021 alone, CROs have garnered massive revenue in the US, and the popularity of these clinical research institutions is projected to grow this year. 

The role of CROs in clinical trials is quite multi-faceted. 

There are a couple of reasons why this way of doing research has garnered so much popularity in recent years.

First, the availability of an instant team of medical experts fixes many of the problems startups in medicine and pharmaceuticals face. Outsourcing some of the heavy liftings in this respect can relieve a lot of weight off your shoulders. 

Secondarily, hiring such a well-versed team is way less expensive than creating one yourself. Since CRO in clinical trials is always required in this form or another, CRO teams are perpetually in business. 

On the other hand, if you were to have your team of medical experts fulfill the same purpose as a CRO team, you would have to pay them monthly salaries even when there is nothing to test. 

Two Main Types of CRO 

As far as CRO in clinical trials, there are two major types of contractor groups that you can hire. Each of these is suitable for slightly different tasks within clinical trials. Here’s a quick explanation: 

  • Specialty CROs – These types of CROs in clinical trials are conducted by teams of experts who concentrate only on one specific medical or pharmaceutical field. For example, teams only test and develop medicine designed to tackle diabetes. Or, there are CRO teams dedicated to rare diseases.
  • Full-Service CROs – A full-service CRO is a type of organization that offers you full research and monitoring service. From pre-clinical trials in labs and on animals to the surveillance of finished products being sold in the market, full-service CROs represent an all-inclusive CRO that can be a useful option for people looking for more support during their drug development process. 

Functions of CRO 

CRO in clinical trials encompasses a wide range of tests, extensive monitoring and post-drug launch market surveillance. 

CRO is a rather wide concept that can include one or all aspects of a clinical trial, depending on if you choose a full-service CRO or a specialized CRO team. Here’s a brief rundown of the most important elements for understanding easier all the work that a CRO team can do: 

Pre-clinical research 

The work of a CRO in clinical trials starts with preparatory steps for clinical research itself. 

Rather than testing new drugs on humans straight away, pre-clinical trials include IND-enabling studies that probe for potential toxicity in the new drug and animal testing. Also, before these, there is the target identification and subsequent validation if the target seems appropriate. 

Clinical trial management 

Once a drug has passed its pre-trial stage, it’s time to move on to the actual human clinical trials. 

Setting this up is more challenging than finding some willing volunteers, though. 

CROs in clinical trials can organize the setting for the testing (this includes facilities and checking if they’re eligible for such a test) as well as clinical monitoring where the effects of the new drug can be observed. 

Also, depending on your contract, you can also task a CRO with finding and recruiting patients for the trial. 

Data Management 

Once everything is set up and the patients are ready to begin their trials, your CRO team will be overwhelmed with valuable clinical research data. 

All of this data needs a lengthy and complicated weeding-out process that helps the CRO retain only important information. After this has been achieved, these crucial data snippets need to be classified, carefully arranged, and saved in directories and other online and offline storage facilities. 

Last but not least, the harvested data needs to be thoroughly analyzed so that an appropriate conclusion can be drawn from the trials. 

Post-marketing surveillance 

After a drug has been launched, the work of a CRO is still not done. 

Observing the effects on the patients who take it for further evidence of effectivity, pharmacovigilance, and risk management all include important post-testing practices of a CRO in clinical trials. 

Conclusion 

Whether you need a bit of help hiring recruits for your drug test trials or you’d rather outsource the entire trial process to a group of experts with some experience in this field, hiring a CRO can be a cost-effective way to get feedback and results relatively quickly. 

The pharma market is getting more and more inundated with new drugs. Thus, having these teams of experts that can weed out the bad ones and monitor the good ones once released means a safer and more risk-free medication environment for the patients.

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