Premier Research

Premier Research is a contract research organization (CRO) providing clinical development services to life science companies developing pharmaceuticals, medical devices, and diagnostics. The company offers end-to-end clinical trial management, regulatory consulting, and specialized research capabilities across the product development lifecycle.

The organization focuses on therapeutic areas including oncology and hematology, neuroscience, rare disease, cell and gene therapy, immunology, dermatology, women's health, analgesia, pediatrics, and medical technology. Their approach emphasizes risk-based monitoring, central oversight, and technology-enabled trial management. The clinical operations team brings experience with complex trial designs including advanced therapies and the 505(b)(2) regulatory pathway.

Premier Research maintains global clinical operations capabilities with expertise in study startup, site management, regulatory project management, and trial master file oversight. The company has co-led industry working groups on risk-based monitoring methodologies in collaboration with regulatory bodies and industry organizations.

Choose Premier Research when developing complex therapies requiring specialized clinical operations expertise, particularly in oncology, rare disease, or advanced therapies. The organization's experience with risk-based monitoring and regulatory pathways like 505(b)(2) provides value for sponsors navigating intricate development programs.

Expect a clinical operations partner with therapeutic specialists, regulatory project managers, and established trial management infrastructure. The company's involvement in industry working groups suggests methodology-driven approaches to trial oversight and quality management.

Premier Research operates exclusively within the clinical research sector of healthcare, supporting pharmaceutical, biotechnology, and medical device companies through the drug and device development process. Their healthcare focus centers on clinical trial management, regulatory compliance, and therapeutic area expertise rather than care delivery or health IT.

The company demonstrates healthcare specialization through therapeutic area experts in oncology, neuroscience, rare disease, women's health, pediatrics, and other clinical domains. Their regulatory project managers handle FDA submissions including pre-IND meetings, investigational drug applications, and new drug applications, requiring deep understanding of healthcare regulatory frameworks.

The ideal client is an emerging biotech or mid-sized pharmaceutical company developing novel therapies in oncology, rare disease, neuroscience, or cell and gene therapy. Organizations benefit most when they require not just operational execution but strategic clinical development expertise, regulatory pathway guidance, and specialized site networks for complex patient populations or advanced therapy administration.