MODIFICATION
B -- Database Development and Management Services for the Division of Parasitic Diseases and Malaria
- Notice Date
- 1/11/2016
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2016-N-17718
- Archive Date
- 2/6/2016
- Point of Contact
- Linda F. Williams, Phone: 770-488-2692
- E-Mail Address
-
luw9@cdc.gov
(luw9@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention (CDC), Center for Global Health (CGH), Division of Parasitic Diseases and Malaria (DPDM), intends to negotiate a sole source contract with EMMES, 401 N. Washington St., Suite 700, Rockville, MD 20850, to provide clinical trial data management services that meet the regulatory and reporting requirements for the following vaccine clinical trial: Safety, Tolerability and Efficacy of PfSPZ Vaccine Administered by Direct Venous Inoculation (DVI) to Healthy Children and Infants 5 Months through 12 Years of Age Living in an Area of High Malaria Transmission in Western Kenya: Age De-escalation and Dose Escalation and a Double Blind, Randomized Placebo-Controlled Trial for Safety and Efficacy. Emmes has experience with PfSPZ malaria vaccine trials and data management in Africa. The efficacy of a malaria vaccine may be related to transmission levels, prior malaria exposure and acquired immunity, and other factors particular to where the vaccine is tested. It is essential that CDC objectively and accurately assesses the performance of the PfSPZ vaccine and compare the performance across multiple malaria transmission levels, populations, countries and age groups. Such comparisons are frequently very complex because of different methods in collecting data, different measures of efficacy, and the use of different analyses. The design of data collection tools, data management and monitoring, and analysis for the majority of the PfSPZ studies done or planned were or will be managed by Emmes. To ensure coordination and comparability, we are requesting sole source contracting of Emmes, so they can provide similar data management services for the trial we are planning, so that a seamless comparison of data can occur between sites. Due to the collaborative nature of this initiative, it is expected that utilization of existing systems, processes, and technical expertise will be the most efficient approach to achieving project objectives. Establishment of data management continuity of support will greatly reduce delays in addressing this urgent global research need. The use of developed processes and existing systems will ensure the results generated from the proposed clinical trial in Kenya can be rapidly and efficiently analyzed upon study completion, and would expedite quick and efficient harmonization, merging, and integration of data from this study with previous/subsequent studies in order to generate the appropriate information needed to inform immunological assessment, safety, and clinical efficacy. The use of other than full and open competition for this acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulations, Subpart 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. This notice of intent is not a request for competitive proposals. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement should submit a Capability Statement demonstrating their abilities to meet this requirement. All responses will be considered. All Capability Statements shall be received by the closing date of this synopsis and shall be submitted in writing. Responses may be sent via email to luw9@cdc.gov. No solicitation will be issued. No telephone inquiries will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2016-N-17718/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta, Georgia, 30341-3724, United States
- Zip Code: 30341-3724
- Zip Code: 30341-3724
- Record
- SN03988115-W 20160113/160111234535-c50ade47a7c4655fb573266b6e241538 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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