GENE THERAPY READY

organizing and administering a network of research sites, namely, business management in the field of clinical trials, specifically, providing governmental registration assistance in the nature of regulatory submission management on behalf of research sites that conduct gene therapy and vaccine research to assist them with clinical research and clinical trials; providing institutional biosafety committee services, namely, providing independent review and oversight of clinical trials involving genetically engineered gene therapy and vaccine research for business purposes

Providing institutional biosafety committee services, namely, providing independent review and oversight of clinical trials involving genetically engineered gene therapy and vaccine research, specifically, evaluating research sites involved in gene therapy and vaccine research clinical trials to determine whether the organizations conform to an established accreditation standard; assessing the readiness of research sites to conduct gene therapy and vaccine research, namely, testing, analysis, and evaluation of gene therapy and vaccine research service providers to determine conformity with established accreditation standards

Providing institutional biosafety committee services, namely, providing independent review and oversight of clinical trials involving genetically engineered gene therapy and vaccine research, specifically, reviewing research protocols and related information to ensure protection of the rights and welfare of human subjects of research; assessing the readiness of research sites to conduct gene therapy and vaccine research, namely, reviewing standards and practices to assure compliance with laws and regulations in the field of clinical trials involving human subjects