Small Business Sources Sought Notice- Statistical Analysis in Support of DMPC Clinical Trials

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of qualified small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) having in-house capability to provide resources to provide support for clinical trials. The National Institute on Drug Abuse (NIDA) is soliciting capability statements from qualified small businesses to provide statistical services in support of Phase 1, Phase 2, and/or Phase 3 clinical trials coordinated by the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMC). This range of support activities encompass the following areas: 1. Providing biostatistical input into the study design, 2. Preparing the statistical analysis plan, 3. Conducting statistical analysis of study results, including interim data, 4. Preparing statistical reports for IND/NDA submission, 5. Designing and generating subject randomization schedules 6. Performing additional programming in order to conduct ad hoc data analyses, 7. Providing statistical consultation and presenting study results in meetings 8. Reviewing and approving Case Report Forms (CRF). A resident Ph.D. statistician is required. Information regarding your organization's capabilities must be in writing and should include information relevant and specific to the above technical area, on each of the following qualifications: (1) Experience: An outline of previous similar projects, specific experience in performing the items listed above; (2) Personnel: Name, professional qualifications and specific experience of scientists and/or technical personnel who may be assigned as project director and other key positions; and (3) Any other specific and relevant information about this particular area of procurement that would improve our knowledge of interested organization's capabilities. Interested organizations 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 tasks 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, titles, telephone numbers and any other information serving to document the organization's capability, e.g., awards, commendations, etc. THIS IS NOT A REQUEST FOR PROPOSAL. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. Interested organizations that believe they possess the capability necessary to successfully undertake the tasks described above should submit an original and two (2) copies of their capability statement by March 8, 2010. Capability statement must provide the following: 1) company name and address; 2) identify your organization's business type inclusive of any and all socio-economic status (e.g. 8(a) certified program participant; small disadvantaged; veteran-owned; service-disabled veteran-owned; HUB Zone or women-owned; 3) point of contact, 4) phone/fax/email; 5) NAICS Codes, and 6) capability information in response to the requirement.