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Understanding the first step of clinical research with Syneos Health
At Syneos Health, clinical research is more than a process — it’s a choice to advance science with care, precision, and respect for those who make it possible: our participants. Every treatment approved and available today has gone through a long and carefully controlled journey, beginning with what is known as a Phase 1 clinical trial.
Let’s take a moment to understand what first phase clinical trials involve, and why they are so important.
The First Time Being Tested in Humans: Safety Above All
Phase 1 trials mark the very beginning of new drug testing in human beings. Before reaching this step, the treatment has been studied extensively in laboratories and preclinical models. But it is only in Phase 1 that we begin to see how it interacts and is metabolized within the human body.
The primary focus at this early stage is safety.
Researchers are looking at answering key questions such as: Is the treatment safe for human use? What dosages are safe and appropriate? How does the body absorb, metabolize, and eliminate the drug? Are there side effects, and at what dose levels do they appear?
This phase typically includes a small group of participants, often healthy individuals. However, in certain cases—such as studies involving autoimmune treatments—it may be more appropriate to enroll participants living with the condition being studied, rather than healthy individuals.
Finding the Right Dose
Another central objective of Phase 1 is determining the optimal dose—one that is both safe and potentially effective. To do this, researchers gradually increase the dose between groups of participants, always under strict medical supervision.
This method, known as dose escalation, allows the study team to closely monitor for any side effects and ensure participant well-being is always protected.
How Phase 1 Fits in the Bigger Picture
Each clinical trial phase has its purpose, but Phase 1 lays the groundwork for everything that follows:
Phase 1: Focus on safety and dosage in a small group of participants.
Phase 2: Begins to explore effectiveness in participants with the condition the treatment targets, while continuing to assess safety.
Phase 3: Confirms effectiveness in larger populations, compares the new treatment with existing ones, and tracks side effects on a broader scale.
Phase 4: Conducted after approval, to monitor long-term outcomes and rare side effects.
Without the knowledge gained in Phase 1/Early Phase clinical trials, none of the later phases would be possible.
The Role of Participants at Syneos Health
Choosing to take part in a Phase 1 trial at Syneos Health means joining a community that plays an essential role and having a real impact to help advance medical science. We recognize that this is often the first time a treatment is being studied in humans — and we acknowledge that responsibility of protecting your safety with the utmost respect.
Our teams are trained, our facilities are state-of-the-art, and our priority is clear: the safety, dignity, and comfort of every participant.
By participating in Phase 1 trial, participants contribute to discoveries that may one day benefit millions. And it all begins with this first, crucial step, of taking the decision to call us and get to know more about us.
If you are located near one of our research units, you may be eligible to participate in study in your area. We conduct clinical trials at both sites, Miami and Quebec, and new studies open regularly.
Ready to Take the First Step?
Interested in joining a clinical trial at Syneos Health? Click here to learn more about upcoming studies.