Encorium Group Inc.

Encorium Group, Inc. engages in the design and management of clinical trials for pharmaceutical, biotechnology, and medical device industries primarily in Europe. The company’s clinical research and development services supporting Phase I through Phase IV clinical trials include study protocol design services; clinical trials management services, such as case report form design, investigator recruitment, patient enrollment, and study monitoring and data collection; data management services comprising case report form review and tracking, data entry, clinical/statistical reports, and writing manuscripts for publication; biostatistics services that assist in the development and review of protocols, design of analysis plans, and design of report formats. Its services also include medical and regulatory services comprising regulatory strategy formulation, new drug application, biologic license application document preparation and review, and quality assurance and liaison with the FDA and other regulatory agencies; quality assurance and compliance services, such as conducting investigator audits, pre-submission protocol compliance audits, and GCP audits; and report writing services, such as presenting statistical analysis findings for data collected during the trial with other clinical data in study form to clients, or to the FDA or other regulatory agencies, as well as patient registries, which populate databases with patient-derived information to analyze and disseminate in various formats. The company offers its services in various therapeutic areas, such as cardiovascular, endocrinology/metabolism, diabetes, neurology, oncology, immunology, vaccines, infectious diseases, gastroenterology, dermatology, hepatology, women’s health, and respiratory medicine. The company was formerly known as Covalent Group, Inc. and changed its name to Encorium Group, Inc. in November 2006. The company was founded in 1989 and is based in Wayne, Pennsylvania.