Rutherford, New Jersey (PRWEB) May 14, 2012
ERA Clinical (http://www.eraclinical.com), a privately held Clinical Research Organization (CRO) in Rutherford, New Jersey is pleased to announce the start of its first global Investigator Initiated Clinical Trial (IIT). The trial is designed to investigate the efficacy and safety of an approved topical ophthalmic antiviral product for an additional indication. ERA is coordinating the activities of ten US investigator sites with additional sites in Brazil and the Philippines. The trial will enroll up to 340 subjects to obtain 84 evaluable subjects for the efficacy analysis. The data will be collected using ERA-Data™ (powered by Trailmaster®), ERA’s electronic data collection tool, and will utilize various efficiencies including centralized electronic risk-based monitoring. The trial is expected to complete in one year. ERA Principal, Lou Dorio commented, “This is a good example of how ERA’s unique tools and efficient methodologies can bring value to IITs and other small studies that are not typically offered by larger CRO organizations.”
ERA Clinical was formed in 2006 in Rutherford, New Jersey to provide CRO services to ethical pharmaceutical and medical device companies. ERA specializes in IIT’s, simple streamlined clinical trials, and trials for medical devices. The company’s executive management and core personnel are career pharmaceutical industry leaders, with expertise in clinical research implementation and management, data management, EDC and statistical analysis. Additional services offered include, regulatory affairs, information technology, medical writing and publication planning. ERA utilizes a combination of full-time and contract personnel to maximize talent and minimize overhead. Project teams are built with industry experts, specifically and ideally suited for each project, who establish seamless operations with sponsors’ personnel. ERA’s unique model provides both flexibility and responsiveness at reduced cost to sponsors.
For more information contact:
Lou Dorio, R.Ph.
Founder and Principal
ERA Clinical, LLC
71 Union Ave, Suite 110
Rutherford, NJ 07070
Direct telephone: +1 (201) 842-7621