Clinical research studies can vary in size from a single center in one country to multi-center studies in multiple countries.
Before an investigational drug, device, or procedure can be tested in people, it goes through years of extensive laboratory research. If this is successful, researchers send the data to the FDA for approval.
Once the drug, device, or procedure is approved, human testing begins. This is where we come into the picture. Sponsors who have made it to this stage contact us about testing their investigational drug.
To ensure trial success, we communicate clearly upfront. Our management team quickly evaluates whether Bioclinica Research is the right fit for the project. We make sure we have the required resources for the study and can meet the sponsor’s enrollment timeline.
After verifying that we can complete the trial successfully, we recruit participants. Each study has different requirements, so not everyone qualifies. It’s important to test experimental medicine in people with the respective condition, but it’s also necessary to conduct research in people of different ages, races, ethnic groups, and gender.
As an investigational drug shows positive signs, more participants are needed for the study and research continues to the next phase.
There are four phases, and each phase is considered a separate study. At the end of each phase, investigators must submit their data to the FDA for approval before continuing to the next phase. After phase three, companies can request FDA approval to market their medicine.
Learn more about the four study phasesLearn more about what we can do.
