Description
The National Institute on Drug Abuse (NIDA) seeks capability statements from qualified small business (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small business, HUB Zone small businesses, small disadvantage businesses, or women-owned small businesses, having the capabilities and experience to assist in the ongoing operations of its Clinical care support services and resources necessary to maintain the research operation of the NIDA IRP Clinical Research Program. Background: The Intramural Research Program (IRP) of the National Institute on Drug Abuse (NIDA) is located on the campus of Johns Hopkins Bayview Medical Center (JHBMC) in Baltimore, Maryland. The (volunteer human participants) and the IRP clinical program conducts multidisciplinary research involving residential and nonresidential clinical studies that interrelate with pre-clinical laboratory investigations. The IRP is looking for a contractor with experience to conduct IRP clinical protocols evaluations and studies on employing addictive or potentially addictive drugs. The research participant population could be active drug abuser or users, clients of drug abuse treatment programs, or persons with a documented history of drug addiction or use. There are protocols conducted which require non-drug abuser or users. For example, cigarette smokers and non-drug using controls would fill this category. The NIDA IRP Clinical Research Program’s research activities are guided by regulations from various federal government agencies to include, but not limited to, FDA, NIH, and OHSR. All personal working for the NIDA IRP Clinical program are required to undergo training in various areas including, but not limited to confidentiality, ethics of clinical research and Human Research Privacy Act. The offeror/contractual staff shall be trained in necessary procedures to comply with current and future requirements mandated for human subject’s protections. The offeror shall maintain records documentation all staff training procedures and are required to follow all NIDA IRP clinical policies. The offeror shall provide the equipment, supplies, and ancillary services necessary to conduct medical consultations and emergency medical care and treatment services. The offeror must have the ability to valuate patients urgently (ER capabilities), and to provide inpatient hospitalization as needed. Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous similar projects, specifically addressing clinical research program. (2) Personnel: Name, professional qualifications and specific experience of professional and technical personnel classifications. Interested organization must demonstrate and document in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated task in an effective and timely manner. Documentation may include, but not be limited to contracts both Government and commercial the organization performed, references, i.e., names, title, telephone numbers and any other information serving to document the organization capability, e.g., awards, and commendations. Small business concerns that believe they possess the capability necessary to successfully undertake the work described above should submit an original and two copies of their capability statement and must provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status, and 6) capability information in response to the requirement and qualifications identified in this notice; and 6) type of small business your organization classifies itself as (i.e. women-owned, HUBZONE, ect).