|
Executive Summary
Physician Research Network (PRN) is a network of physicians that is dedicated to conducting high quality multi-center clinical research trials according to the guidelines of Food and Drug Administration (FDA) and International Conference on Harmonization. (ICH). Established in 2000, in partnership with private practice physicians, PRN has participated in 35-plus drug and device studies. Currently, PRN is conducting more than 20 Phase 3 and Phase 4 clinical trials on various disease entities. Our management team consists of highly trained medical, clinical and business professionals, which has 75-plus years of combined experience in clinical research.
Our Mission
The primary goal of our organization is to conduct high-caliber drug and device clinical trials through a network of trained academic and private practice physicians in accordance with the GCP-ICH guidelines.
Our Commitment
The clinical trials are and will be conducted following the stringent criteria developed by the U.S. Department of Health and Human Services, Office of Human Research Protections (OHRP), and Office of Civil Rights (OCR) to protect the safety of human subjects and to safeguard the confidentiality of protected health information of the volunteer subjects. Briefly, our objectives are to:
• Provide support in overall management of research projects at clinical sites
• Assist in identification and recruitment of potential study volunteers
• Process necessary documentation to enroll physicians in clinical trials; and to obtain approval of internal review board (IRB)
• Participate in negotiation of contracts to properly allocate required resources
• Educate and train investigators and coordinators to conduct clinical trials, and to maintain drug and documents as per the ICH-GCP and HIPAA guidelines
|