Premier Research

Premier Research is a global full-service CRO delivering clinical research and development solutions across the complete drug development lifecycle. The organization provides comprehensive capabilities spanning study design, study startup, medical affairs, biostatistics and data management, central monitoring, clinical monitoring and site management, project and risk management, safety and pharmacovigilance, quality and compliance, and medical writing. Additionally, Premier offers functional service provider (FSP) consulting in program and regulatory strategy, drug and device development strategy, market access and new product strategy, regulatory affairs, regulatory submissions and publishing services, and trial master file quality review and remediation.

The company maintains deep therapeutic expertise across oncology and hematology, neuroscience, rare disease, cell and gene therapy, immunology and internal medicine, dermatology, women's health, analgesia, pediatrics, 505(b)(2) pathway development, and medical device (MedTech) applications. Premier's translational research and MIDD (Model-Informed Drug Development) services include chemistry, manufacturing and controls (CMC) support, nonclinical services and toxicology, and clinical pharmacology with pharmacometrics capabilities.

Technology infrastructure includes study management platforms, RBQM (Risk-Based Quality Management), and eClinical solutions to support virtual clinical trial services and observational, registry, and post-marketing studies. The organization emphasizes strategic, technology-powered solutions to accelerate development timelines from milestone to milestone, with a focus on turning breakthrough science into life-changing drugs, devices, and diagnostics.