SOURCES SOUGHT
A -- DMID Clinical Research Operations and Management Support (CROMS)
- Notice Date
- 1/21/2009
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- SS-RFP-NIAID-DMID-NIHAI2009052
- Archive Date
- 2/19/2009
- Point of Contact
- Deborah A Baca,, Phone: 301-443-4490, Barbara A Shadrick,, Phone: 301-496-7288
- E-Mail Address
-
dbaca@mail.nih.gov, bs92y@nih.gov
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This SOURCES SOUGHT NOTICE is to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) that can provide clinical trials management support services to DMID and DMID-supported investigators. Activities include clinical site assessment; preparation and monitoring; centralized safety monitoring and document management; and a web-based clinical trials management system. The information from this market research will help the Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) plan their acquisition strategy. Please be sure to indicate if you have a GSA schedule contract, a contract on GSA 8(a) STARS, or a contract on GSA VETS GWAC. THIS IS STRICTLY MARKET RESEARCH. The DMID, NIAID, NIH WILL NOT ENTERTAIN QUESTIONS REGARDING THIS MARKET RESEARCH. BACKGROUND The evaluation of new and improved vaccine and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of DMID. Through an extensive network of grant and contract research programs, the Division of Microbiology and Infectious Diseases (DMID), NIAID supports a broad range of clinical research, including single-site and multi-center Phase 1, Phase 2, Phase 3, and Phase 4 clinical trials of bacterial, viral and parasitic vaccines, therapeutics, and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. Support is also provided for a variety of other studies, including: targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. Clinical trials and clinical studies are also supported to evaluate the safety and efficacy of vaccines and therapeutics against potential agents of bioterrorism, including NIAID Category A, B and C priority biodefense pathogens and toxins (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm), and to meet critical public health needs and opportunities for emerging and re-emerging infectious diseases. RESPONSE INFORMATION In order to respond to this notice, contractors must be able to clearly convey its experience and/or ability to perform the following tasks identified: 1.safety monitoring, including proposed safety reporting systems, tracking and handling of serious adverse events (SAEs); 2.planning and conduct of clinical site monitoring and reporting; 3.planning and conduct of pre-study activities, including clinical site assessments; development and implementation of clinical site Quality Management Programs; and receipt, assessment and maintenance of essential regulatory documentation; 4.protocol development support services, including the development of clinical protocols and protocol-related documents; 5.maintenance of a centralized data reporting system to track all clinical support service activities, including SAE data and reporting; quality management activities; protocol development activities; site essential documentation activities; and metrics for all supported clinical trials (e.g., protocol accrual, site visits, SAEs, etc); 6.development and implementation of a Quality Assurance and Quality Control plan to ensure clinical sites comply with domestic and country-specific regulations governing human subjects research; 7.development of annual IND reports, and final clinical study reports; 8.development and implementation of training programs for clinical site personnel regarding the conduct of clinical trials; and 9.the ability to expand staffing during any contract year if Options to increase hours are exercised as directed by NIAID/DMID. Assume that: 1.On the effective date of the contract 200 clinical trials will be active or in development. 2.Clinical trials to be supported will be performed in both domestic and foreign locales. 3.Forty-five (45) new clinical trials, with an average enrollment of 100 participants per trial, will be initiated in each year of the contract period of performance. In addition, contractors must be able to provide a total level of effort of 102.45 FTEs per year (213,096 total hours per year based on a Work Year of 2080 hours) for a period of performance of seven years (Base period plus six, one-year Options). In any year of the contract, contractors must also be able to respond to requests to expend effort based on the exercise of Options in increments of 2 FTEs, 5 FTEs or 8 FTEs. Contractors must provide expertise in the following areas: 1.Principal Investigator/Project Management 2.Quality Assurance and Quality Management 3.CRA Managers 4.CRA Monitors 5.Training 6.Medical Writing 7.Safety and Medical Monitoring 8.IT Systems Development and Management 9.Web Services 10.Records Coordinator 11.Administrative Data, Monitoring, Meeting and Regulatory Support Each response should include the following Business Information: •DUNS. •Company Name. •Company Address. •Company Point of Contact, Phone and Email address •Current GSA Schedules appropriate to this Sources Sought. •Do you have a Government approved accounting system? If so, please identify the agency that approved the system. •Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/index.asp Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company’s experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed or being performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Project Director, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Teaming Arrangements: All teaming arrangements should also include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged. Responses must be submitted not later than February 4, 2009; 3:00 PM, EDT. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Debby Baca, Contract Specialist. She can be e-mailed at the address provided below. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line Reference: SS-RFP-NIAID-DMID-NIHAI2009052. A paper copy can be sent via regular mail at the address provided below. National Institutes of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions ATTN: Debby Baca 6700 B Rockledge Drive, Room 3108 MSC 7612 Bethesda, Maryland 20892-7612 Email Address: dbaca@niaid.nih.gov GENERAL INFORMATION This Sources Sought Notice is for information and planning purposes only and should not be construed as a commitment by the Government. This is not a solicitation announcement for proposals and no contract will be awarded from this Notice. No reimbursement will be made for any costs associated with providing information in response to this Notice. Respondents will not be notified of the results of this evaluation. Capability statements will not be returned and will not be accepted after the due date. As previously stated, the Government will not entertain questions regarding this Market Research; however, general questions may be forwarded to the following: Contracts Specialist: Debby Baca Email Address: dbaca@niaid.nih.gov Contracting Officer: Barbara Shadrick Email Address: bs92y@nih.gov
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- Record
- SN01735349-W 20090123/090121215041-40e8e2f315d918160798fb1e78067147 (fbodaily.com)
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