Clinical Research Experience and Training Requirements

Paragon Research Center specializes in primary care research. PRC's main areas of research are in obesity, smoking cessation, insomnia, chronic non-malignant pain such as headaches, low back pain, osteoarthritis, migraines, hypertension, dyslipidemia, metabolic syndrome, COPD, diabetes, tremors, and restless leg syndrome. The site conducts approximately 20 to 25 studies per year and has experience in conducting over 80 clinical trials. All coordinators are licensed nurses, have a minimum of 5 years experience each in performing clinical trials, are certified by ACRP or CCRP, and are all HAZMAT and IATA certified. They are required to attend the monthly GCP and SOP training offered at the center and must complete CME requirements for ongoing research  and re-certification.  All principle investigators at PRC are also certified by ACRP, certified by their medical specialty board, must attend the monthly GCP and Standard Operating Procedure training and must complete CME requirements for continued ACRP and medical board certification. All coordinators are experienced with IVRS systems (ICON, RAMOS) and EDC (Medidata, Inform, PDS).

Each month there are 3 mandatory weekly meetings of the research staff.  One meeting focuses on recruitment and retention strategies for each trial along with reviewing all adverse events, IND safety reports, and achieved metrics. The other meeting is an internal audit of research charts and regulatory binders for compliance with the protocol, SOPs, and FDA, ICH-GCP guidelines. The third meeting is training on GCP and Paragon's SOPs.