Premier Research

Health Decisions, Inc. is a full-service clinical research organization based in Durham, North Carolina, that specializes in clinical studies related to women's health and diagnostics across various therapeutic areas. Founded in 1989, the company has conducted over 100 trials focusing primarily on women's health issues such as contraception and postmenopausal symptoms. In recent years, Health Decisions has expanded its expertise to include diagnostics studies, notably a significant PMA study for high-risk HPV types related to cervical cancer. The company offers a comprehensive suite of services including project management, medical writing, data management, biostatistics, regulatory compliance, and strategic consulting. By providing tailored solutions to its partners, Health Decisions aims to facilitate the rapid and efficient development of women's health products and diagnostic tests, helping clients achieve their business objectives with minimal risk.

Camargo Pharmaceutical Services offers specialized drug development services focused on the 505(b)(2) approval pathway and similar European processes. The company provides a comprehensive range of integrated solutions that cover all stages of product development, from initial concept to commercial launch. By emphasizing complex drug development programs, Camargo helps sponsors navigate regulatory challenges and achieve their milestones efficiently, balancing speed and cost-effectiveness in the process.

Cytespace provides scalable investigator site services in order to improve efficiency, quality, and patient recruitment. Cytespace is a division of Premier Research and is staffed with dedicated employees who have separate reporting, management, and SOPs. It collaborates directly with investigators, sponsors, and CROs in India to help improve patient feasibility and enrollment goals. It is founded in 2011 and is based in Bangalore, Karnataka.

Regulatory Professionals, Inc. is a regulatory consultancy that specializes in providing regulatory expertise and solutions tailored for biotechnology, pharmaceutical, and medical device companies. Founded in 1995 and based in Newark, California, the company offers a range of services, including clinical and preclinical development, chemistry, manufacturing and controls (CMC) development, quality assurance, and regulatory writing. Regulatory Professionals focuses on serving small to mid-size companies, facilitating their product development and registration processes globally. With a reputation as a solutions-oriented advisor, the firm integrates seamlessly into clients' existing scientific, regulatory, and publishing teams, delivering strategic guidance and support throughout all phases of drug and device development. As of July 2018, Regulatory Professionals operates as a subsidiary of Premier Research International LLC.

SCIREX, now part of Premier Research, operates as a Contract Research Organization that provides a wide range of clinical research services to pharmaceutical and biotechnology companies. Its offerings include clinical operations management, data management, and statistical services, all aimed at supporting the drug development process. The company specializes in site management services, particularly in the therapeutic areas of psychiatry and analgesia, ensuring that clinical trials are conducted efficiently and effectively. By delivering comprehensive solutions, SCIREX plays a crucial role in advancing medical research and innovation.