Regulatory Management
Our experienced staff, quality assurance processes, suitable management structure, and physical facilities allow us to provide the highest level of regulatory support to government and industry clients, investigators, and research site staff, including the following:
- Review, preparation, and submission of regulatory documents, reports, and other agreements
- Design and conduct of regulatory educational and training activities
- Provision of specialized expertise to both clinical site and product development staff in domestic and international settings and at resource-rich as well as resource-poor sites
- Conduct of clinical site and preclinical development or clinical laboratory audits
As the Clinical Coordinating Center for the National Heart, Lung, and Blood Institute's Gene Therapy Resource Program, we provide management and regulatory support to the program and qualifying investigators. The regulatory support available to investigators covers an array of services, including the following:
- Investigational New Drug Application (IND) preparation
- Annual report preparation
- Communications with the Food and Drug Administration
- Data Safety Monitoring Boards (DSMBs) and oversight bodies specific to Gene Therapy
A full view of our regulatory services for this program can be found on the Gene Therapy Resource Program Web site.
We also serve as the Regulatory Management Center for the Division of Allergy, Immunology and Transplantation (DAIT) Immune Tolerance Network (ITN) global clinical trials. Our staff provides the following services:
- Support to ensure regulatory and Good Clinical Practice (GCP) compliance, including technical and administrative assistance in the preparation, assembly, and submission of original clinical trial applications (CTAs) for ITN trials in countries outside the United States
- Tracking and reporting of IND Safety Reports for all ITN-sponsored clinical trials
- Assistance with the preparation and distribution of Investigator Brochures, Cooperative Research and Development Agreements (CRADAs), and both Clinical Trial and Screening Agreements
Historically, we have provided regulatory support to the Centers for Disease Control and Prevention (CDC) for the emergency use of products in the national stockpile. We served as the Division of AIDS (DAIDS), National Institutes of Health (NIH) Regulatory Operations Center for the major research networks, including the Adult AIDS Clinical Trials Group (ACTG); the Pediatric AIDS Clinical Trials Group (PACTG); the Community Programs for Clinical Research on AIDS (CPCRA); the HIV Vaccine Trials Network (HVTN); and the Vaccine Research Center (VRC). We have developed, customized, and implemented a number of database systems to track and report on a myriad of regulatory activities supporting management, operational, and coordinating centers.