NICHD_Pediatric_and_Maternal_HIV_Studies_DCC_Sources_Sought_02_15_22_1.pdf

SOURCES SOUGHT ANNOUNCEMENT

NICHD International and Domestic Pediatric and Maternal HIV Studies and Other Highly Infectious Diseases Data Coordinating Center

75N94022R00003

Synopsis:

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources to perform a potential requirement; (2) whether they are small businesses; 8(a) small businesses, veteran owned small businesses; woman owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification system (NAICS) code for the potential acquisition.

Your responses to the information requested will assist the government in determining the appropriate acquisition method, including whether a small business set aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The requirement is assigned a code of 541715 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1,000 employees or less.

Background:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) requires logistical, technical, and administrative support to maintain, coordinate, train, monitor and manage a multisite network of clinical centers conducting intervention trials and other research on treatment, prevention, diagnosis, epidemiology, and natural history of HIV infection and disease as well as other priority infectious diseases affecting in pediatric, adolescent, and maternal patient populations, including both domestic and international clinical sites. The NICHD is interested in identifying whether there any interested small business concerns with the requisite capabilities to serve as the NICHD International and Domestic Pediatric and Maternal HIV Studies and Other Highly Infectious Diseases Data Coordinating Center.

The current Data Coordinating Center contract presently manages a network of 24 clinical centers. Domestically, there are 14 sites, located in 13 cities and 9 states/territories (including Puerto Rico). Internationally, there are 10 sites: 5 in different areas of Brazil, 3 in Africa, and 2 in Thailand.

Project Requirements:

The potential acquisition will involve the following types of activities:

1. Serve as the data coordinating center for all aspects of management and monitoring of clinical research sites in the NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network. Sites are currently located in the US, Latin America, Africa and Asia and they may also be located in other regions during the project period.

The NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network (“NICHD Network”) has been funded through the NICHD Data Coordinating Center contract since 1987. The NICHD Network consists of domestic and international clinical sites that enroll study subjects in trials related to preventing and treating HIV infection and its complications in neonates, infants, children, adolescents, and pregnant women, as well as selected clinical trials of gender specific manifestations of HIV infection in nonpregnant women. The Network enrolls into trials that are part of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network, the Adult AIDS Clinical Trials Group (AACTG) funded by the National Institute of Allergy and Infectious Diseases (NIAID), and the NICHD funded Adolescent HIV Medicine Trials Network (ATN). The Network also has collaborated on clinical trials in the past and could collaborate in the future with the Centers for Disease Controls and Prevention (CDC) and the Pediatric European Network for Treatment of AIDS

(PENTA).

NICHD also supports laboratorybased pathogenesisoriented research in the context of clinical trials. The Data Coordinating Center provides support to clinical trials site investigators with special laboratory expertise for the conduct of specialized pathogenesisbased studies in the context of PACTG protocols. The Data Coordinating Center provides special support to international sites, such as providing specimen transport through a central Data Coordinating Center contract.

2. Perform Site Monitoring of Phase III NICHDFunded Investigator Initiated

International trials in pregnant and nonpregnant women, infants, children, and adolescents.

As the NICHD international research grant portfolio has increased to include large phase III clinical trials conducted in resource limited countries, there is an increasing need to ensure that such investigatorinitiated trials are conducted ethically, in accordance with Good Clinical Practices, and with attention to human subject safety. The Data

Coordinating Center will conduct site monitoring for selected NICHD grantees conducting large clinical trials to ensure appropriate trial conduct.

3. As the HIV epidemic has evolved and other infectious diseases have emerged in the

United State and globally, this contract and clinical trial sites address or will address gaps as they arise, including HIV associated co infections (such as tuberculosis, hepatitis, and malaria) in children and pregnant women. Also, these clinical trial sites are anticipated to address research into the epidemiology, natural history, pathogenesis, transmission, treatment, and prevention of other significant infectious diseases, including: congenital infections, such as Zika virus and cytomegalovirus; tropical diseases, specifically those that affect children and pregnant women; and vaccine preventable disease in infants, children, adolescents, and women.

Capability Statements:

To be deemed capable of performing this requirement, the interested organizations must submit a capability statement that clearly demonstrates and provide a description and documented evidence of the experience and expertise of the staff to perform the tasks listed below. Provide names of projects and references. Response must include sufficient detail to demonstrate:

1. Experience to effectively and flexibly run a very large and complex multicenter international and domestic clinical trials network that implements and manages studies in collaboration with multiple other networks (with the ability to make appropriate modification of data collection and submission to match that of other networks).

2. Demonstrated capability and experience in managing over 20 million dollars per year in subcontracts with multiple clinical sites, laboratories, and other subcontracts such as courier services for shipping biospecimens.

3. Demonstrated capability, as demonstrated by prior experience, to monitor an average of 25 network clinical trials at multiple domestic and international trials sites as well as monitoring selected investigator initiated clinical trials.

4. Demonstrated capability to manage at least 25 simultaneous subcontracts.

5. Demonstrated capability to assume ongoing clinical trials work at multiple U.S. and international sites within approximately 60 to 90 days following contract award.

Thus, interested organizations must demonstrate the ability and capacity to within approximately 60 to 90 days following contract award assume responsibility to support approximately 25 subcontracts valued over $20 million.

6. Demonstrated capability to support data systems that interface and interact with data systems used by 3 or more different networks using different data management systems (example the AACTG, ATN and IMPAACT).

7. Since the Data Coordinating Center will manage and monitor clinical trials conducted in highly vulnerable populations, neonates, children, adolescents, and pregnant women, that require specific knowledge of federal regulations related to research in these populations and knowledge of the unique characteristics of such populations when conducting research, the contractor is required to have substantial prior experience with HIV related studies in these populations. Therefore, the interested organizations must demonstrate specific knowledge of federal regulations related to research in these populations and knowledge of the unique research characteristics of such populations.

8. Demonstrated ability and have prior experience in training, monitoring and management of clinical trials in the United States and in low resource settings in Africa, Latin America, and Asia.

9. Demonstrated capability to provide personnel, facilities, and other services necessary to maintain and coordinate clinical treatment, prevention, natural history, epidemiologic, and diagnostic research studies at participating centers of studies conducted within the NICHD International and Domestic Pediatric and Maternal HIV Studies Coordinating Center contract. The Contractor must be able to continue the research studies within the NICHD Network described above into new studies requested and approved byNICHD.

10. Demonstrated capability to provide the clinical trial sites and laboratory services.

Currently, the work is done through multiple subcontracted research centers (domestic and international). Therefore, the capability statement must demonstrate the organization’s extensive experience in subcontract award and administration preferably including international research sites, including drafting, negotiating, executing, administering, monitoring, renewing and/or modifying as needed subcontracts with current participating sites and laboratories (domestic and international) and any new clinical centers or laboratories as designated by NICHD, and provide support for subcontracted clinical and laboratory centers of the NICHD network.

11. Demonstrated capability to provide services to assure regulatory compliance for research activities of sites subcontracted by Data Coordinating Center for performance of studies. This includes:

a. Maintaining a communications system in compliance with U.S. Food and Drug Administration (FDA) requirements for the submission of Adverse Experience Reports.

b. Plans for acquisition, distribution, dispensing, handling, administration, and accountability of study drugs.

c. Site monitoring for quality assurance of research conducted at all subcontracted clinical and laboratory sites and for selected international clinical trials

d. Ability to maintain trial master files and documentation to support registrational and Individual New Drug studies for FDA and European Medicines Agency and ability to satisfactorily undergo regulatory audits and inspections and support clinical research sites for the same.

12. Demonstrated capability to provide clinical and statistical analysis services. This includes the following:

a. Scientific, technical, and administrative support for the development, implementation, and analysis of the specified research

b. Development of data elements and forms

c. Timely and accurate data collection

d. Central data entry

e. Data quality assurance

f. Retrieval of source documentation

g. Generation of data and safety monitoring reports

h. Training for staff of subcontracted clinical and laboratory centers in data management procedures

i. Provision for data input, editing, electronic data storage, database management, data retrieval, and statistical analysis

j. Electronic data transmission and electronic mail transmission with subcontracted clinical and laboratory centers and collaborating Statistical and Data Analysis Center databases.

13. Demonstrated capability to provide services for implementation and monitoring of clinical trials at all participating NICHD clinical and laboratory centers and for selected international clinical trials. Ability to assure compliance by sites with all requirements for protocol implementation, including IRB review and approval prior to protocol initiation, patient consent and confidentiality requirements, and Federal bioresearch regulations and requirements for security and confidentiality of research records.

Ability to oversee annual human subjects training for all relevant clinical site staff members. Demonstrated capability to develop site specific, protocol specific budgets for each protocol. Ability to train staff of subcontracted clinical and laboratory centers in procedures for implementation and conduct of specific protocols.

14. Demonstrated capability to provide services for development and review of new and ongoing research activities, including a protocol development team and protocol development plan. Ability to draft and edit protocols; maintain necessary documentation for application submissions in compliance with FDA requirements; provide support for the planning and conduct of meetings of protocol committees and subcommittees, data and safety monitoring boards, and investigators; administrative, technical, and logistical support for research activities.

15. The Contractor must be able to provide consultants with specialized expertise related to clinical trial efforts.

16. Demonstrated capability for electronic information systems to be validated and to be either compliant or obtain compliance with the Federal Information Security Modernization Act (FISMA).

Disclaimer and Important Notes: This notice does not obligate the government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this Notice. This notice is for information purposes only.

CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any nonproprietary technical information in any resultant solicitation(s).

Responses:

Interested Small Businesses that believe they possess the capabilities necessary to undertake this project should submit an electronic copy of their capability statement addressing the areas listed above to the attention of Elizabeth Osinski, Contracting Officer, (Email:

eo43m@nih.gov) and Alice Pagán, Contracting Officer (Email: alice.pagan@nih.gov).

Please state clearly in the subject line of the email that it is in response to the Sources Sought notice no. 75N94022R00003. Please limit responses to 20 pages or less, exclusive of resumes.

Electronic capability statements should be received by the Contracting Officers by 5:00 PM Eastern time on March 2, 2022. Respondents must submit their capability statement via electronic submission only. Capability statements must identify the 1) organization name, address, point of contact, contact phone number, and email address; 2) Small Business status of the organization, NAICS code along with DUNS number, size and type of business (e.g., 8(a), HUBZone, etc.). No phone calls will be accepted. The designated NAICS code for this effort is 541715 and the size standard is 1,000 employees or less.

mailto:eo43m@nih.gov mailto:alice.pagan@nih.gov