Independent data safety monitoring board of flight analogs bed restactivities

NASA/JSC has a requirement for the services of an independent assessmentorganization to provide safety oversight of test subjects participating in the 6 headdown tilt bed rest studies. NASA/JSC intends to purchase the services from Theradex System Inc.The bed rest studies require a Data Safety Monitoring Board (DSMB) that shall supportethical and safe scientific conduct of individual research studies in order to maintainintegrity of research enterprises sponsored by the JSC Human Research Program (HRP) andapproved by the NASA regulatory organization, Committee for the Protection of HumanSubjects (CPHS). During the study, independent analyses of HRP research using recognizedand credentialed experts in designated disciplines for evaluations shall be conducted.Theradex Systems has developed a unique understanding of our requirements within spacelife science. Theradex System is the only vendor that can meet our requirement.The Government intends to acquire a commercial item using FAR Part 12.Interested organizations may submit their capabilities and qualifications to perform theeffort in writing to the identified point of contact not later than 12:30 p.m. local timeon August 4, 2010. Such capabilities/qualifications will be evaluated solely for thepurpose of determining whether or not to conduct this procurement on a competitive basis. A determination by the Government not to compete this proposed effort on a full and opencompetition basis, based upon responses to this notice, is solely within the discretionof the government.Oral communications are not acceptable in response to this notice.All responsible sources may submit an offer which shall be considered by the agency.An Ombudsman has been appointed. See NASA Specific Note "B".Any referenced notes may be viewed at the following URLs linked below.