Clinical Trials Support

Added: January 2, 2008 The National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center has a requirement for program support services to the Clinical Trials Core, which conducts Phase I trials of candidate HIV vaccines as well as other vaccines. The contractor will be required to provide the following types of services: 1). Volunteer recruitment of approximately 80 adult volunteers annually in an out patient setting, retention, and follow-up; 2) Site selection, acquisition, maintenance and management; 3) Clinical monitoring, quality assurance and auditing; 4) Controlled storage and preparation of vaccine products for administration to volunteer; 5) Clinical care of volunteers; 6) Collection, storage, and delivery of volunteer specimens; 7) Development and preparation of clinical study records and documents for research and regulatory needs; 8) Secure electronic warehousing of all clinical study records and documents. NIAID intends to award a one-year cost-reimbursement type contract beginning on or about June 5, 2008 with the option for four additional contract years. The NAICS code is 541990: All Other Professional, Scientific and Technical Services. The solicitation will be posted to www.fedbizopps.gov for download on or about January 16, 2008. No hard copies will be distributed.