Getting ready for FDA clinical trials can be an intimidating and overwhelming process—especially if this is your first time going through it. Since you need to be able to pass all four phases of the FDA's clinical trial process to get your products in the hands of patients who need them, you must familiarize yourself with each one.

Let’s learn about the four different phases and discuss how you can guarantee quality assurance during each step.

Quality Assurance During All 4 Phases of Clinical Trials

Exceptional quality assurance relies on maintaining detailed records during every step of your product’s lifecycle.

Implementing an enterprise quality management software (eQMS) solution makes creating and keeping track of required documents for FDA compliance a breeze. With so much at stake, you shouldn't decide what software to use lightly, however. You need to make sure that you partner with a software provider that keeps the unique needs of life sciences companies like yours in mind.

Make an informed decision on which software provider to use by learning the 12 questions you should ask before you purchase an eQMS.

What Are Clinical Trials?

To answer this question, let’s take a look at the definition that the FDA provides for clinical trials...

“Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.” [Source: FDA.gov]

Related Reading: How Long Does the FDA Medical Device Approval Process Take?

What Types of Clinical Trials Are There?

The FDA has seven different types of clinical trials: preventive trials, screening trials, diagnostic trials, treatment trials, genetic studies, quality of life studies, and epidemiological studies.

Let’s take a look at each of these in more depth so you can understand the differences between them all.

Preventative trials are for testing new medications and vaccines. Medications include vitamins and supplements, as well as other pharmaceutical drugs. Researchers use this type of trial to determine if the medication or vaccine can lower someone’s risk of specific diseases or conditions.

Screening trials focus on finding ways to detect and diagnose certain diseases or conditions before patients experience any symptoms. Researchers typically use this type of trial to discover if they can lower a person’s risk of harm or death with earlier detection of the disease or condition.

Diagnostic trials are similar to screening trials, except that they focus on detecting and diagnosing diseases or conditions after the patients start experiencing symptoms.

Treatment trials test new medications, medical devices, psychotherapy, surgery, or other types of therapies or treatments to collect data to determine if it's safe and does what it's supposed to do.

Genetic studies are performed to learn new ways to predict genetic disorders earlier so we can help those patients who are at risk of developing these types of diseases or conditions.

Quality of life studies are used to evaluate the quality of life of a person who is suffering from a chronic illness. The focus is on finding solutions to ease their symptoms and improve their quality of life.

Epidemiological studies help scientists detect prevalence patterns and causes and control of specific disorders that affect particular groups of people. New call-to-action

The 4 Phases of Clinical Trials

Phase One

Before phase one, your product should be tested in a lab to determine whether or not there is enough evidence to say that your product might provide a benefit to the patients who are going to use it.

You won’t know if your product is safe or effective for sure at this point, but you should have enough data collected to suggest that it’s worth looking into further.

During phase one, a small group of willing participants who would be ideal patients for your product will use it and report their results back to you. These participants will be monitored closely for any signs of adverse effects or symptoms you will need to report.

Phase Two

Assuming the results from phase one found that your product was effective and safe for use, you’ll be ready to test it out on a higher number of participants in phase two.

If your product is a medication, you will have established the appropriate dosage amount in phase one.

Now that your product has been tested on enough people for the FDA to be reasonably sure that it’s worth distributing on a larger scale, you’ll move on to phase three.

Phase Three

In phase three, you will test your product in more depth on much larger groups of people. You’ll also monitor the side effects and the efficacy of the drug for every patient.

Placebos may be used in your trial if the product you’re testing is a medication. Placebos help act as a control so you can ensure that your patient’s perception and hopes don’t skew the results you’re getting.

Phase Four

At this stage of the FDA clinical trials, your product has received FDA approval, and your marketing campaigns are underway.

Studies performed in phase 4 focus on discovering the long-term effects of your product and gathering more data on how it interacts with other drugs if your product is a medication.

Related Reading: What Are the Differences in the FDA Medical Device Classes?

How an eQMS Can Help You Get Ready for Clinical Trials

Making it through the initial research stages of your product’s development relies on your ability to maintain detailed records of your process and findings.

You can do this with a paper-based quality management system—but we don’t recommend it. Paper-based systems are outdated and inefficient. You are more likely to lose or misplace critical documents with these types of systems.

“Coming from a manual, paper-based system, it’s amazing how it all just works. Qualio has forever changed how we manage quality.” — Tara Fitzpatrick, Quality Manager of Rowa Pharmaceuticals

At Qualio, we understand the unique challenges you face in the life sciences industry, and that’s why we created an eQMS for companies just like yours.

With Qualio, you’ll be able to create and track crucial documentation the FDA and other regulatory organizations require you to have.

We put together a guide to help you make an informed decision about what software provider to use so that you know for sure that we’re a good fit for you.

Download our free guide to learn the 12 questions you need to ask before investing in an eQMS for your company. New call-to-action

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Published by Robert Fenton May 7, 2020
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