Surveillance for Antimicrobial Susceptibility of Gonorrhoeae in Transgender Women (TGW) in the Vicinity of Pattaya, Thailand
|Agency:||Department of the Army|
|Level of Government:||Federal|
|Posted Date:||Jul 12, 2019|
|Due Date:||Jul 17, 2019|
Jul 10, 20196:04 pm
Notice Type: Request for Information (RFI)
Response Date: 17 July 2019
NAICS: 541990 - All Other Professional Scientific and Technical Services
Scope: This new requirement is for the contractor to provide support services for the surveillance for antimicrobial susceptibility of Gonorrhoeae in transgender women (TGW) in Pattaya area, Thailand. This support will include filed advertisement. Additionally, this support will include the rental site infrastructure for sample enrollment, sample compensation, sample collection, and sample storage before transporting the samples to perform laboratory testing at AFRIMS.
Objectives: The objective of this requirement is to provide support services for the surveillance for antimicrobial susceptibility of Gonorrhoeae in transgender women (TGW) in Pattaya area, Thailand. This support will include filed advertisement. Additionally, this support will include the rental site infrastructure for sample enrollment, sample compensation, sample collection, and sample storage before transporting the samples to perform laboratory testing at AFRIMS.
Specific Tasks / Requirements
1. Projects shall be conducted in accordance with the prescribed protocols, current or amended as may be available and approved by international and local regulatory authorities.
2. The conduct of the study shall be based on the applicable portions of the US Code of Federal Regulations (CFRs) for clinical studies, including but not limited to Good Clinical Practice Regulations (Title 21 CFR Parts 11, 50, 54, 56), the Health Insurance Portability and Accountability Act (HIPPA) of 1996 (Pub L. 104-191, 110 Stat. 1936, enacted August 21, 1996), and International Conference on Harmonization Guidelines for Good Clinical Practices (GCPs) (ICH Guidelines for Good Clinical Practice (E6), Published May 9, 1997).
3. Execution of the protocol shall collaborate with the USAMRDC, local Regulatory Authorities, USAMD-AFRIMS, and local collaborators, stakeholders and communities.
4. The contractor shall apply the principles of Good Clinical Laboratory Practice (GCLP) in all aspect of the studies, meeting quality and management standards to ensure laboratory data integrity, accuracy, and completeness. The contractor will coordinate with AFRIMS and the study teams in the execution of the projects and laboratory operations, to include, but not limited to: organization and personnel, facilities, equipment use and maintenance, maintain adequate supply of materials and reagents, standard operating procedures in sample management encompassing sample collection, transport and chain of custody, sample storage/retention of samples, proper record keeping/reporting as well as ensure reports are available for quality control/quality audits.
5. Sample Enrollment Support. The contractor shall:
a. Identify potentially eligible subjects using study inclusion criteria.
b. Generate subject identification code list (Deliverable 1)
c. Obtain written informed consent forms form participants (Deliverable 2)
6. Sample Compensation Support. The contractor shall distribute the sample compensation to the participants who comply with all study inclusion criteria.
7. The contractor shall administer management, field advertisement and social communication for understanding the research aim, scope and community advantages, as appropriate
8. Sample Collection Support. The contractor shall:
a. Support participant samples collection and storage
b. Identify best possible shipping methods and ship/deliver these samples to AFRIMS (Deliverable 3)
9. Required Reporting. The contractor shall:
a. Report protocol deviations to the WRAIR IRB and Thai MoPH (Deliverable 4)
b. Report all unanticipated problems involving risks to subjects or others to the WRAIR IRB and Thai MoPH (Deliverable 5)
10. Site Infrastructure. The contractor shall provide management support for the use of physical sites for biomedical research such as clinics, health centers, laboratories, office space, and/or hospitals that are appropriate to the scientific requirements of the research project. Infrastructure costs may include site rental, utilities, and facility upgrades as necessary to meet regulatory requirements. (Deliverable 6)
Interested parties are asked to respond to this RFI and submit a capabilities statement that supports the focus of this RFI. Please review the place of performance requirements. Please submit written responses via email in Microsoft Office 2000 or 2007 format. All responses should be complete: in 12-point font; and not to exceed 5 pages total, including graphics, tables, and appendices.
No hardcopies shall be accepted. No written solicitation document is available at this time. Telephone requests will not be honored, and no bidders list shall be maintained. No inquiries regarding any potential future acquisition activities shall be entertained.
There is proprietary information involved in this requirement which may preclude some established clinical trial centers from competing on this requirement, although no decisions have been finalized at this time.
Potential offerors are requested to direct all questions via email to the Point of Contact listed below. Responses are due to the Point of Contact, Ms. Flodean Billings at email: firstname.lastname@example.org no later than 9:00AM EST, Wednesday, July 17, 2019.
CAUTION: This is an active requirement. Contractors are strictly prohibited from discussing this requirement with any member of the program office. All discussion shall be with the point of contact listed above.
DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any kinds of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned.
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