About HCR

Heartland Clinical Research, Inc. (HCR) is multi-specialty, independently owned, dedicated research facility located in the heart of the USA.  HCR was started in 2001 and has a proven track record in the research industry.  We specialize in conducting phase II-IV trials and have had an opportunity to work with many pharmaceutical companies both large and small.  All of our staff are well trained with the industry standards and our physicians are all board certified.

What is a clinical/medical research study?

Before an investigational medication can be approved as a treatment for a specific illness or disease, researchers must prove that the investigational medication is safe and that it works. They do this by testing the investigational medication in many research studies. These are also called clinical trials, clinical studies, or clinical research studies. Even after a medicine is “approved” for doctors to prescribe, clinical research studies can continue to be conducted to increase understanding about how a particular medicine can be most effectively used by doctors. The medicine being investigated in a clinical research study is called an “investigational medicine”. Without clinical studies, new medications cannot be developed.

Why do people participate in clinical research studies?

People participate in clinical research studies for various reasons including:

  • Gaining access to investigational medical treatments that may not be otherwise available
  • Helping researchers understand if and how an investigational medications works and why
  • Helping others in the future who have the same illness or disease

What are the different phases of clinical research?

Clinical research studies are traditionally divided into four phases. Each phase is designed to gather specific information about the study drug or treatment.


Preclinical Studies:

In preclinical development, also named preclinical studies or nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile. Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools.

Phase 1 Study

Phase I Studies

If an investigational medicine is initially shown to be safe and well tolerated, it moves on to a Phase II study. These studies are designed to see how well the study medicine works on the disease or illness it is being tested to help, usually in a larger group of participants.

The first human tests of investigational medicines or therapies occur in Phase I studies. Phase I clinical research studies are designed to determine the best dose of the study medicine and to check for any potential side effects. These studies usually involve small numbers of healthy participants. Phase I studies use study medicines that have never been tested in humans, because of this they may involve significant risks.

Phase 2 Studies

Phase II Studies

If an investigational medicine is initially shown to be safe and well tolerated, it moves on to a Phase II study. These studies are designed to see how well the study medicine works on the disease or illness it is being tested to help, usually in a larger group of participants.

Phase 3 Studies

Phase III Studies

If the investigational medicine is shown to be effective in Phase II studies, it may move on to Phase III studies. Phase III studies evaluate the safety and how well the medicine works in hundreds, or even many thousands of participants. Often Phase III studies compare the study medicine to an existing standard treatment or placebo (pills that look like the study drug but has no medicine in it). When a participant enters the study, they are randomly selected (like the flip of a coin) to take the comparing study medication treatments being evaluated. Scientists use the term randomized when participants are enrolled into a study.

Phase 4 Studies

Phase IV Studies

These studies are conducted after a medicine has been approved to be used by doctors by the regulatory bodies. Phase IV studies typically involve a large number of participants. They may evaluate new uses of existing medicines or be used to detect side effects that did not appear during Phase III studies.