The Pharmaceutical Management Branch (PMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), is charged with providing comprehensive pharmaceutical support for clinical trials sponsored by the National Cancer Institute. The DCTD sponsors intramural and extramural research for the clinical development and evaluation of potentially effective cancer treatments. The purpose of the PMB support contract is to facilitate the management and distribution of all agents supplied on CTEP supported clinical trials with respect to inventory control, order authorization, and associated document management. The contractor also manages the investigator and associate registration processes for participation in NCI sponsored cancer clinical trials. They also manage the Enterprise Core Module (ECM) and associated Help Desk. The ECM serves CTEP in the real-time maintenance (i.e., data entry, storage, reporting, analysis, retrieval) of people and organization information for those who participate on clinical trials. The information is collected from both remote investigator sites and CTEP offices and branches. Additional responsibilities include management of the Access Identity Maintenance (AIM) module which provides user accounts and access to Associates and Investigators participating in NCI-sponsored clinical trials. The contractor also supports the PMB pharmacists by providing the necessary reports concerning agent usage to facilitate the proper management of their portfolio of agents. The contractor facilitates the authorization and distribution of investigational agents for off-protocol/compassionate access to investigational agents via the Special Exception and/or Treatment Referral Center Protocols. In addition to providing the PMB with the necessary support resources as outlined above, the contractor provides word processing, data entry, photocopying, filing, telephone, faxing, scanning, and other clerical support. The contractor provides and maintains an off-site location including all equipment necessary at that site, for other personnel and file storage. In very general terms, Investigator and Associate registration work is done at the contractor site and agent related activities are handled at the government site.
