Premier Research

Health Decisions, Inc. is a clinical research organization (CRO) based in Durham, North Carolina, that specializes in providing comprehensive clinical research services. Founded in 1989, the company has a strong focus on women’s health, having conducted over 100 clinical trials in areas such as contraception and postmenopausal vasomotor symptoms. In addition to its work in women’s health, Health Decisions has expanded into diagnostics, successfully conducting studies for high-risk HPV types, preterm birth risk, and various oncology indications. The company offers a range of services including project management, medical writing, data management, biostatistics, quality management, and regulatory compliance. Health Decisions aims to facilitate the rapid and efficient development of women's health products and diagnostics, providing tailored solutions that align with the specific needs of its partners.

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 consulting firm based in Newark, California, founded in 1995. The company specializes in providing regulatory expertise and solutions to biotechnology, pharmaceutical, and medical device companies. Its services include clinical and preclinical support, chemistry, manufacturing, and controls (CMC) development, quality assurance, and regulatory writing. Regulatory Professionals focuses on serving small to mid-sized firms, assisting them in advancing the development and registration of their products across global markets. The company is recognized for its ability to integrate seamlessly into existing scientific, regulatory, and publishing teams, positioning itself as a trusted partner and solutions-oriented advisor. As of July 2018, Regulatory Professionals operates as a subsidiary of Premier Research International LLC.

SCIREX is a contract research organization that specializes in providing a comprehensive range of clinical research services to pharmaceutical and biotechnology companies. It focuses on clinical operations management, data management, and statistical services. In addition to these core offerings, SCIREX also provides site management services, particularly in the therapeutic areas of psychiatry and analgesia. The company is dedicated to supporting clients throughout the clinical development process, ensuring robust management and analysis of data to facilitate effective drug development.