CLINICAL CENTRAL LABORATORY SERVICES
Presolicitation Notice Information
Introduction
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases (DMID) has a requirement to establish clinical central laboratory services to support multi-center clinical trials.
Introduction
The National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases (DMID) have a need for clinical central laboratory services to support multi-center clinical trials.
Description
Research supported by the NIAID, NIH, DHHS, strives to understand, treat, and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to study, control, and prevent diseases caused by all infectious agents. This includes basic, clinical, and applied research to develop and evaluate therapeutics, vaccines and diagnostics that are funded through a variety of research grants and contracts.
The evaluation of new and improved vaccine, diagnostics and therapeutic candidates in Clinical trials and clinical studies is an essential element of the efforts of the NIAID. The Vaccine and Treatment Evaluation Units (VTEU), supported by the NIAID since the 1960’s, have designed and conducted a broad range of clinical studies and 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. These have included Investigational Device Exemption (IDE), Investigational New Drug (IND) and non-IND trials, many Phase I first in-man clinical trials, and Phase II proof-of-concept trials. The VTEUs have also undertaken 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.
The VTEUs also have an important role in responding to emerging public health needs at the direction of NIAID. There are approximately 75 active clinical trials per year in the VTEUs. Several of these clinical trials/studies were performed to address emergent public health needs, such as the zika and yellow fever outbreaks.
The VTEUs conduct clinical studies and Phase 0 through Phase IV clinical trials related to infectious diseases in a variety of domestic and international populations. These populations include healthy volunteers from birth to mature adults, pregnant women and subjects with endemic diseases for the specific international location. Many clinical trials conducted in the VTEUs are multi-center trials. When data is collected from multiple local laboratories that use different testing methodologies, reference ranges, and standard operating procedures, difficulties in data interpretation and delays in study timelines may result. A need for a clinical central laboratory, a laboratory that will process all screening and safety labs collected at all sites participating in one trial, has been identified.
The contracts to be awarded under the attached Request for Proposal (RFP) will provide clinical central laboratory services.
Offerors are expected to have the expertise, personnel, and facilities to meet requirements stated in the RFP, and be able to demonstrate their capability to perform the requirements, to include but not limited to, the following:
to perform clinical laboratory screening and safety testing, such as hematology, chemistry, HIV, HBC, HCV, urinalysis, gonorrhea and chlamydia to support multi-center clinical trials, including maintaining current Clinical Laboratory Improvement Amendment certification (http://www.cms.gov/clia) and other certifications, as appropriate.
availability, adequacy and suitability of clinical laboratory facilities, equipment and other resources of the Offeror and all proposed subcontractors to perform clinical laboratory testing in accordance with federal regulatory requirements and guidelines, including Good Laboratory Practices, Good Clinical Practices, NIH, NIAID and DMID policies and procedures and the scope and requirements of the RFP.
provision of adequate scientific and technical personnel who have expertise with Good Laboratory Practices and Good Clinical Practices.
provision of technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities.
Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about March 11, 2020 and may be accessed through Beta.SAM https://beta.sam.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
For solicitations where proposals will be received via the NIAID electronic Contract Proposal Submission (eCPS) website (ALL R&D solicitations MUST be in eCPS) add the following:
For the solicitation, the NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable.
For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit.
75N93020R00004 Department of Health and Human Services National Institutes of Health
2/7/20, 4:30 PM CLINICAL CENTRAL LABORATORY SERVICES
Sources Sought Notice Information
Introduction
This is a 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; (2) small businesses, HUBZone small businesses, service-disabled veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, or small disadvantaged businesses classifications; and (3) size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Information submitted in response to this notice 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 621511 shall not submit a response to this notice.
A determination by the Government not to compete this requirement as a small business set-aside, based upon responses to this notice, is solely within the discretion of the Government.
Responses submitted must indicate if you have a GSA schedule contract, a contract on GSA 8(a) STARS, or a contract on GSA VETS GWAC.
Background
Research supported by the NIAID, NIH, DHHS, strives to understand, treat, and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The DMID supports extramural research to study, control, and prevent diseases caused by all infectious agents. This includes basic, clinical, and applied research to develop and evaluate therapeutics, vaccines and diagnostics that are funded through a variety of research grants and contracts.
The evaluation of new and improved vaccine, diagnostics and therapeutic candidates in
clinical trials and clinical studies is an essential element of the efforts of the NIAID. The Vaccine and Treatment Evaluation Units (VTEU), supported by the NIAID since the
1960’s, have designed and conducted a broad range of clinical studies and 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. These have included Investigational Device Exemption (IDE), Investigational New Drug (IND) and non-IND trials, many Phase I first in-human clinical trials, and Phase II proof-of-concept trials. The VTEUs have also undertaken 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.
The VTEUs also have an important role in responding to emerging public health needs at the direction of NIAID. There are approximately 75 active clinical trials per year in the VTEUs. Several of these clinical trials/studies were performed to address emergent public health needs, such as the zika and yellow fever outbreaks.
The VTEUs conduct clinical studies and Phase 0 through Phase IV clinical trials related to infectious diseases in a variety of domestic and international populations. These populations include healthy volunteers from birth to mature adults, pregnant women and subjects with endemic diseases for the specific international location.
Purpose and Objectives
The contract(s) to be awarded under a Request for Proposal (RFP) for the requirements stated herein will provide central lab services to support clinical studies conducted at the VTEUs. The NIAID anticipates awarding multiple Indefinite Delivery Indefinite Quantity (IDIQ) contracts to fulfill the technical requirements of DMID. However, the NIAID reserves the right to award a single award IDIQ.
Task orders for specific tasks will be competed for issuance among the IDIQ pool after the award of IDIQ contract(s).
All projects carried out under resultant contracts must be conducted in a manner consistent with all applicable local and Federal regulations.
The anticipated start date is on/or about January 2021 with an ordering period of five (5) years.
Capability Statement/Information Sought
Sources must have the expertise, personnel, and facilities to meet the requirements of the project stated herein. Tailored capability statements submitted as a result of this notice must demonstrate the organization’s qualifications and experience, specifically providing evidence as to the organization’s capability to perform the requirements stated herein, with particular attention to the following areas:
Perform clinical laboratory testing to support multi-center clinical trials, including but not limited to the following:
Maintaining current Clinical Laboratory Improvement Amendments (CLIA) certification (http://www.cms.gov/clia) and other certifications as appropriate;
Providing clinical supply kits, investigator manuals, lab requisition forms and shipping supplies;
Providing courier services and tracking for all clinical supply and clinical specimen shipments;
Providing investigator training and ongoing support;
Performing cumulative data transmissions sent to the Statistical Data and Coordinating Center (SDCC) daily, weekly or monthly, depending on the needs of the study; and
Performing data management support to include maintenance of the results database, prompt issue resolution and documentation of data revisions.
2. The availability, adequacy and suitability of clinical laboratory facilities, equipment and other resources of the organization and all proposed subcontractors to perform clinical laboratory testing in accordance with federal regulatory requirements and guidelines, including Good Laboratory Practices, Good Clinical Practices, NIH, NIAID and DMID policies and procedures.
The ability to provide a technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities.
RFP-NIAID-DMID-75N93020R00004 Department of Health and Human Services National Institutes of Health
1/9/20, 9:37 AM CLINICAL CENTRAL LABORATORY SERVICES
Sources Sought Notice Information
Introduction
This is a 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; (2) small businesses, HUBZone small businesses, service-disabled veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, or small disadvantaged businesses classifications; and (3) size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Information submitted in response to this notice 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 621511 shall not submit a response to this notice.
A determination by the Government not to compete this requirement as a small business set-aside, based upon responses to this notice, is solely within the discretion of the Government.
Responses submitted must indicate if you have a GSA schedule contract, a contract on GSA 8(a) STARS, or a contract on GSA VETS GWAC.
Background
Research supported by the NIAID, NIH, DHHS, strives to understand, treat, and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The DMID supports extramural research to study, control, and prevent diseases caused by all infectious agents. This includes basic, clinical, and applied research to develop and evaluate therapeutics, vaccines and diagnostics that are funded through a variety of research grants and contracts.
The evaluation of new and improved vaccine, diagnostics and therapeutic candidates in
clinical trials and clinical studies is an essential element of the efforts of the NIAID. The Vaccine and Treatment Evaluation Units (VTEU), supported by the NIAID since the
1960’s, have designed and conducted a broad range of clinical studies and 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. These have included Investigational Device Exemption (IDE), Investigational New Drug (IND) and non-IND trials, many Phase I first in-human clinical trials, and Phase II proof-of-concept trials. The VTEUs have also undertaken 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.
The VTEUs also have an important role in responding to emerging public health needs at the direction of NIAID. There are approximately 75 active clinical trials per year in the VTEUs. Several of these clinical trials/studies were performed to address emergent public health needs, such as the zika and yellow fever outbreaks.
The VTEUs conduct clinical studies and Phase 0 through Phase IV clinical trials related to infectious diseases in a variety of domestic and international populations. These populations include healthy volunteers from birth to mature adults, pregnant women and subjects with endemic diseases for the specific international location.
Purpose and Objectives
The contract(s) to be awarded under a Request for Proposal (RFP) for the requirements stated herein will provide central lab services to support clinical studies conducted at the VTEUs. The NIAID anticipates awarding multiple Indefinite Delivery Indefinite Quantity (IDIQ) contracts to fulfill the technical requirements of DMID. However, the NIAID reserves the right to award a single award IDIQ.
Task orders for specific tasks will be competed for issuance among the IDIQ pool after the award of IDIQ contract(s).
All projects carried out under resultant contracts must be conducted in a manner consistent with all applicable local and Federal regulations.
The anticipated start date is on/or about January 2021 with an ordering period of five (5) years.
Capability Statement/Information Sought
Sources must have the expertise, personnel, and facilities to meet the requirements of the project stated herein. Tailored capability statements submitted as a result of this notice must demonstrate the organization’s qualifications and experience, specifically providing evidence as to the organization’s capability to perform the requirements stated herein, with particular attention to the following areas:
Perform clinical laboratory testing to support multi-center clinical trials, including but not limited to the following:
Maintaining current Clinical Laboratory Improvement Amendments (CLIA) certification (http://www.cms.gov/clia) and other certifications as appropriate;
Providing clinical supply kits, investigator manuals, lab requisition forms and shipping supplies;
Providing courier services and tracking for all clinical supply and clinical specimen shipments;
Providing investigator training and ongoing support;
Performing cumulative data transmissions sent to the Statistical Data and Coordinating Center (SDCC) daily, weekly or monthly, depending on the needs of the study; and
Performing data management support to include maintenance of the results database, prompt issue resolution and documentation of data revisions.
2. The availability, adequacy and suitability of clinical laboratory facilities, equipment and other resources of the organization and all proposed subcontractors to perform clinical laboratory testing in accordance with federal regulatory requirements and guidelines, including Good Laboratory Practices, Good Clinical Practices, NIH, NIAID and DMID policies and procedures.
The ability to provide a technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities.
RFP-NIAID-DMID-75N93020R00004 Department of Health and Human Services National Institutes of Health
1/8/20, 10:43 AM