National Institute of Allergy and Infectious Diseases (NIAID) Clinical Data and Safety Management Center (CDSMC)
Closed Solicitation Posted
This opportunity was awarded. See the award notice from , or the latest solicitation from .
- Solicitation number
- RFP-75N93020R00011
- Agency
-
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- USA
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Allergy and Infectious Diseases is soliciting proposals for a Clinical Data and Safety Management Center contract to provide clinical research data management, safety monitoring, and pharmacovigilance services. Offerors must demonstrate experience in centralized data and safety management for multi-site clinical research. The contract will have a one-year base period and four one-year options. Proposals are due October 13, 2020 and will be evaluated based on technical qualifications, past performance, and price/cost. Services will support programs such as the Immune Tolerance Network, Asthma and Allergic Diseases Clinical Research, and Autoimmunity Centers of Excellence.
The opportunity is set aside for total small businesses. The primary NAICS code is 541715 and PSC code R699. The contract has a total small business designation and potential award values will depend on available funding and scope of work under task orders. Services will include data management for clinical research networks through 2026 and safety/regulatory support for studies conducted globally. The place of performance will be within the United States.
Notice text
5 versions
Update #5 · Latest ·
Amendment 4 is to answer questions and to extend the due date of this RFP until 3:00 P.M. ET on Tuesday, October 13, 2020.
Amendment 3 is to answer questions. All questions must be submited by September 28, 2020.
RFP 20R00011-2.pdf adds attachments.
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 Allergy, Immunology, and Transplantation (DAIT) has a requirement to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases.
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research that focuses on protective immune responses and immune-mediated diseases through grants and contracts awarded to domestic and foreign organizations. A critical component of the Division’s mission targets clinical research to develop new and/or improved therapies and prevention strategies through rigorous evaluation of the safety and efficacy of investigational products and approaches, clinical studies to elucidate underlying mechanisms, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of natural history, genetics/genomics and/or other “omic”, and lifetime exposures. Research encompasses a broad range of immune-mediated diseases, including: (i) allergic diseases and asthma; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; (iv) primary immune deficiency disorders;(v) and other immune system disorders and treatments to enhance immune functions.
The purpose of this request for proposals is to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases, examples of which are listed here:
- Immune Tolerance Network (ITN)
- Asthma and Allergic Diseases Clinical Research Programs
- Atopic Dermatitis Research Network (ADRN).
- Consortium for Food Allergy Research (CoFAR).
- Inner City Asthma Consortium (ICAC) which is to be replaced in 2021 by the Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN)
- Autoimmune Diseases Clinical Research Programs
- Autoimmunity Centers of Excellence (ACE)
- Transplantation Clinical Research Programs
- Clinical Trials in Organ Transplantation (CTOT).
- Clinical Trials in Organ Transplantation in Children (CTOT-C).
- Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA).
- Statistical & Clinical Coordinating Centers (SCCCs)
- Allergy & Asthma SCCC
- Autoimmune Diseases SCCC
- Transplantation SCCC
- Clinical Site Monitoring Center (CSMC)
- Regulatory Management Center (RMC)
Update #4 ·
Amendment 3 is to answer questions. All questions must be submited by September 28, 2020.
RFP 20R00011-2.pdf adds attachments.
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 Allergy, Immunology, and Transplantation (DAIT) has a requirement to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases.
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research that focuses on protective immune responses and immune-mediated diseases through grants and contracts awarded to domestic and foreign organizations. A critical component of the Division’s mission targets clinical research to develop new and/or improved therapies and prevention strategies through rigorous evaluation of the safety and efficacy of investigational products and approaches, clinical studies to elucidate underlying mechanisms, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of natural history, genetics/genomics and/or other “omic”, and lifetime exposures. Research encompasses a broad range of immune-mediated diseases, including: (i) allergic diseases and asthma; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; (iv) primary immune deficiency disorders;(v) and other immune system disorders and treatments to enhance immune functions.
The purpose of this request for proposals is to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases, examples of which are listed here:
- Immune Tolerance Network (ITN)
- Asthma and Allergic Diseases Clinical Research Programs
- Atopic Dermatitis Research Network (ADRN).
- Consortium for Food Allergy Research (CoFAR).
- Inner City Asthma Consortium (ICAC) which is to be replaced in 2021 by the Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN)
- Autoimmune Diseases Clinical Research Programs
- Autoimmunity Centers of Excellence (ACE)
- Transplantation Clinical Research Programs
- Clinical Trials in Organ Transplantation (CTOT).
- Clinical Trials in Organ Transplantation in Children (CTOT-C).
- Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA).
- Statistical & Clinical Coordinating Centers (SCCCs)
- Allergy & Asthma SCCC
- Autoimmune Diseases SCCC
- Transplantation SCCC
- Clinical Site Monitoring Center (CSMC)
- Regulatory Management Center (RMC)
Update #3 ·
RFP 20R00011-2.pdf adds attachments.
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 Allergy, Immunology, and Transplantation (DAIT) has a requirement to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases.
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research that focuses on protective immune responses and immune-mediated diseases through grants and contracts awarded to domestic and foreign organizations. A critical component of the Division’s mission targets clinical research to develop new and/or improved therapies and prevention strategies through rigorous evaluation of the safety and efficacy of investigational products and approaches, clinical studies to elucidate underlying mechanisms, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of natural history, genetics/genomics and/or other “omic”, and lifetime exposures. Research encompasses a broad range of immune-mediated diseases, including: (i) allergic diseases and asthma; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; (iv) primary immune deficiency disorders;(v) and other immune system disorders and treatments to enhance immune functions.
The purpose of this request for proposals is to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases, examples of which are listed here:
- Immune Tolerance Network (ITN)
- Asthma and Allergic Diseases Clinical Research Programs
- Atopic Dermatitis Research Network (ADRN).
- Consortium for Food Allergy Research (CoFAR).
- Inner City Asthma Consortium (ICAC) which is to be replaced in 2021 by the Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN)
- Autoimmune Diseases Clinical Research Programs
- Autoimmunity Centers of Excellence (ACE)
- Transplantation Clinical Research Programs
- Clinical Trials in Organ Transplantation (CTOT).
- Clinical Trials in Organ Transplantation in Children (CTOT-C).
- Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA).
- Statistical & Clinical Coordinating Centers (SCCCs)
- Allergy & Asthma SCCC
- Autoimmune Diseases SCCC
- Transplantation SCCC
- Clinical Site Monitoring Center (CSMC)
- Regulatory Management Center (RMC)
Update #2 ·
RFP 20R00011-1.pdf corrects the due date.
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 Allergy, Immunology, and Transplantation (DAIT) has a requirement to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases.
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research that focuses on protective immune responses and immune-mediated diseases through grants and contracts awarded to domestic and foreign organizations. A critical component of the Division’s mission targets clinical research to develop new and/or improved therapies and prevention strategies through rigorous evaluation of the safety and efficacy of investigational products and approaches, clinical studies to elucidate underlying mechanisms, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of natural history, genetics/genomics and/or other “omic”, and lifetime exposures. Research encompasses a broad range of immune-mediated diseases, including: (i) allergic diseases and asthma; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; (iv) primary immune deficiency disorders;(v) and other immune system disorders and treatments to enhance immune functions.
The purpose of this request for proposals is to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases, examples of which are listed here:
- Immune Tolerance Network (ITN)
- Asthma and Allergic Diseases Clinical Research Programs
- Atopic Dermatitis Research Network (ADRN).
- Consortium for Food Allergy Research (CoFAR).
- Inner City Asthma Consortium (ICAC) which is to be replaced in 2021 by the Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN)
- Autoimmune Diseases Clinical Research Programs
- Autoimmunity Centers of Excellence (ACE)
- Transplantation Clinical Research Programs
- Clinical Trials in Organ Transplantation (CTOT).
- Clinical Trials in Organ Transplantation in Children (CTOT-C).
- Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA).
- Statistical & Clinical Coordinating Centers (SCCCs)
- Allergy & Asthma SCCC
- Autoimmune Diseases SCCC
- Transplantation SCCC
- Clinical Site Monitoring Center (CSMC)
- Regulatory Management Center (RMC)
Update #1 ·
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 Allergy, Immunology, and Transplantation (DAIT) has a requirement to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases.
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research that focuses on protective immune responses and immune-mediated diseases through grants and contracts awarded to domestic and foreign organizations. A critical component of the Division’s mission targets clinical research to develop new and/or improved therapies and prevention strategies through rigorous evaluation of the safety and efficacy of investigational products and approaches, clinical studies to elucidate underlying mechanisms, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of natural history, genetics/genomics and/or other “omic”, and lifetime exposures. Research encompasses a broad range of immune-mediated diseases, including: (i) allergic diseases and asthma; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; (iv) primary immune deficiency disorders;(v) and other immune system disorders and treatments to enhance immune functions.
The purpose of this request for proposals is to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases, examples of which are listed here:
- Immune Tolerance Network (ITN)
- Asthma and Allergic Diseases Clinical Research Programs
- Atopic Dermatitis Research Network (ADRN).
- Consortium for Food Allergy Research (CoFAR).
- Inner City Asthma Consortium (ICAC) which is to be replaced in 2021 by the Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN)
- Autoimmune Diseases Clinical Research Programs
- Autoimmunity Centers of Excellence (ACE)
- Transplantation Clinical Research Programs
- Clinical Trials in Organ Transplantation (CTOT).
- Clinical Trials in Organ Transplantation in Children (CTOT-C).
- Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA).
- Statistical & Clinical Coordinating Centers (SCCCs)
- Allergy & Asthma SCCC
- Autoimmune Diseases SCCC
- Transplantation SCCC
- Clinical Site Monitoring Center (CSMC)
- Regulatory Management Center (RMC)
Files
| File | Type | Posted |
|---|---|---|
| Amend 4.pdf | ||
| Amend 3 .pdf | ||
| Attach 25 Emp sep checklist.pdf | ||
| Att 22 CumulativeInclusionEnrollmentReport.docx | DOCX document | |
| RFP 20R00011-2.pdf | ||
| RFP 20R00011-1.pdf | ||
| RFP 20R00011_OA 06012020.pdf |
Notice history
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