What We Do, We Do Well!
Biotrial is a global clinical research organization with a strong presence in the United States, specializing in early-phase clinical development. Our US operations focus primarily on Phase I clinical trials conducted in healthy volunteers, as well as selected Phase I and Phase II studies in patients, supporting the safe and efficient transition of investigational products from preclinical research to later stages of development.
We partner with pharmaceutical and biotechnology companies to deliver high-quality, regulatory-compliant clinical studies, while offering study participants a structured, closely monitored environment in which they can contribute directly to medical progress. Our integrated approach combines clinical expertise, operational excellence, and a strong commitment to participant safety.
Our Expertise in Clinical Trials
Biotrial in Newark, NJ primarily conducts Phase 1 clinical trials with healthy volunteers. These trials focus on assessing the safety and tolerance of new drugs, with some volunteers receiving the drug and others a placebo.
We also sometimes test innovative medical devices, such as connected t-shirts and headbands.
Biotrial is proud to be one of the most trusted clinical research centers on the United States East Coast.
Safety Comes First
At Biotrial, volunteer safety is our primary concern. We adhere to the Good Clinical Practice (GCP) standards, ensuring the highest level of integrity in all clinical research. Our goal is to contribute to advancing medical science while keeping volunteer safety and comfort our top priority.
We conduct comprehensive medical examinations before, during, and after each study. Our team of Principal Investigators ensures that all clinical trials follow approved protocols.
We also implement fingerprint verification to ensure participants do not enroll in multiple trials simultaneously, safeguarding their well-being and maintaining the integrity of the studies.
Regulatory Compliance
In the U.S., the Food and Drug Administration (FDA) regulates clinical trials to protect participants and ensure they have reliable information to make informed decisions. The Institutional Review Board (IRB), a designated committee, reviews and monitors all biomedical research involving human subjects.
Both regulatory bodies must approve every trial protocol to ensure ethical compliance. A human clinical trial is authorized only if laboratory and animal studies show favorable results.
Biotrial strictly follows all decisions made by the FDA and Institutional Review Board (IRB).
We believe in full transparency throughout the clinical trial process. During the screening visit, participants receive informed consent information and can ask as many questions as needed. This step fosters trust and ensures a clear understanding of the clinical trial process.
We also respect and protect the privacy of our volunteers. We adhere to the Health Insurance Portability and Accountability Act (HIPAA), ensuring that all personal and medical information remains confidential.
