Pre-Solicitation_notice.docx
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- Attached to
- Data Management and Data Warehousing Federal contract opportunity
- Solicitation number
- NIHAO201800011
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Attached is the Pre-Solicitation Notice for Data Management and Data Warehousing
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| File | Type | Posted |
|---|---|---|
| DM_RFP_Questions_and_Responses-_Amendment_1.pdf | ||
| Data_Management_Final_RFP_with_attachments.pdf |
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PRESOLICITATION NOTICE
Data Management and Data Warehousing
NIHAO201800011
Type of Requirement
| |_| | New Requirement |
| |X| | Follow-on (Contract No.: HHSN272201500001C) |
| |_| | Other (specify):________________ |
Place of Performance
| |_| | Place of performance is unknown at this time |
| |X| | Place of performance is known. Address or general location: Contractor’s site_ |
Recompetition The EMMES Corporation 401 N. St. Suite 700 Rockville, MD 20850
Contracting Office Address
Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821
Duration of contract: __One Year Base Period with 6 One-year Options
Anticipated award date: __September 15, 2019____
Pre-Solicitation Notice Information
Introduction
The Dale and Betty Bumpers Vaccine Research Center (VRC) at the National Institutes of Health (NIH) was established to facilitate basic and clinical research in vaccine development and testing and is housed in the National Institute of Allergy and Infectious Diseases (NIAID). The VRC is dedicated to improving global human health through the rigorous pursuit of effective vaccines for human diseases including Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), diseases identified as BioDefense concerns, and emerging/re-emerging infectious diseases. The VRC program combines basic, translational, and applied research, along with regulatory science and clinical material manufacturing, to translate vaccine candidates from the bench to the clinic. This interdisciplinary method along with collaboration within the federal, academia, and industry communities is the basis for VRC’s approach to advance and accelerate the science of vaccine development. The Clinical Trials Program (CTP), within the VRC, implements human clinical research trials; conducting Phase I/II/IIb trials of candidate vaccines and/or other immune modulators for infectious diseases and agents such as HIV, Influenza, Ebola, Zika, Malaria, and Chikungunya.
The U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and well-being of subjects involved in clinical research conducted by federal agencies. In this regard, Code of Federal Regulations (CFR), 45CFR46, applies to all clinical research studies. For clinical trials that involve investigational products, the Food and Drug Administration (FDA) requires that the studies conform to 21CFR312 and advises that standards for Good Clinical Practice (GCP) and various guidance documents for key issues be incorporated into clinical trial design and conduct.
Description
Currently, the VRC has a need for a comprehensive data management plan and reliable Clinical Data Management System (CDMS) to achieve compliance and meeting requirements for the proper conduct of protocols for subject screening, collection of research samples, clinical trials subject enrollment, and follow-up activities for evaluation of new investigational products.
Additionally, to compile, store, analyze and report data collected from clinical trials, the Contractor shall establish and provide access to Data Warehousing and Reporting Tools (DWRT). A Data Warehouse must comply with 21CFR11 and Study Data Tabulation Model requirements of the FDA. Compliance with these standards ensures that the data and reported results are credible and accurate and that the rights, safety, and well-being of clinical trial subjects are protected.
The Contractor shall provide access to and utilization of a tested and proven commercial or proprietary CDMS software for the Electronic Data Capture (EDC) of clinical trials data. The Contractor-provided system shall meet the standards set by the CFRs and recommended in FDA guidance, and shall be compatible with existing VRC-utilized CDMS systems (SAS data or SAS-convertible or transferable data). All data must be accessible in real time, secure, and auditable at all times. Additionally, all clinical data must be formatted so that reports and analyses can be quickly generated for submissions to the VRC, FDA, and designated collaborators as needed. The proposed CDMS must be usable within six weeks of award. The Contractor will provide statistical support services related to data contained in the CDMS, including SAS datasets. Warehousing data will mainly be generated from the CDMS.
This requirement shall provide the NIAID with the ability to perform frequent review of interim safety and accrual data during the conduct of clinical trials, ensure that clinical and laboratory results related to clinical trials of novel vaccine constructs can be rapidly and efficiently analyzed upon study completion, and provide more effective opportunities for necessary compilation and comparison of data across studies.
The anticipated start date is on/or about September 15, 2019 with a One Year Base and 6 One-year Options.
Offerors are expected to have the expertise, personnel, and facilities to meet the requirements of the project, and be able to demonstrate their capability to perform this requirement, with particular attention to the follow areas:
| 1) | Establish and manage a state-of-the-art tested and proven commercial or proprietary CDMS software for the Electronic Data Capture (EDC) of clinical trials data. The Contractor provided system shall meet the standards set by the CFRs and recommended in FDA guidance, and shall be compatible with existing VRC-utilized CDMS systems (SAS data or SAS-convertible of transferable data.) All data must be accessible in real time, secure, and auditable at all times. Additionally, all clinical data must be formatted so the reports and analyses can be quickly generated for submission to the VRC, FDA, and designated collaborators as needed. |
| 2) | The proposed CDMS must be usable within six weeks of award. |
| 3) | The Contractor will provide statistical support services related to data contained in the CDMS, including SAS datasets. |
| 4) | The Contractor will provide regulatory support services related to data contained in the CDMS to include ClinicalTrials.gov registration and data uploads. |
| 5) | Warehousing data will mainly be generated from the CDMS. |
| 6) | This requirement shall provide the NIAID with the ability to perform frequent review of interim safety and accrual data during the conduct of clinical trials, ensure that clinical and laboratory results related to clinical trials of novel vaccine constructs can be rapidly and efficiently analyzed upon study completion, and provide more effective opportunities for necessary compilation and comparison of data across studies. |
| 7) | The Government will not be providing a system or provide support to build this system. Offerors must establish and provide access to CDMS. |
| 8) | The availability, adequacy, and suitability of an established center facility, equipment, and other resources including computer equipment, network infrastructure, database management systems, and overall information technology systems administration of the organization and all proposed subcontractors for data collection, computer processing, storage, tracking and retrieval of all study data and study-related information. |
| 9) | The ability to provide adequate scientific and technical personnel who have knowledge of protocols for subject screening, collection of research samples, clinical trials subject enrollment, and follow-up activities for evaluation of new investigational products. Must also have demonstrated ability to identify and resolve problems encountered in meeting milestones and timelines for projects of similar scope, size, and complexity. |
| 10) | The ability to provide a technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities. |
Instructions
Any responsible Offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about November 26, 2018 and may be accessed through FedBizOpps http://www.fedbizopps.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 this solicitation, the NIAID requires proposals to be submitted: Online 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."
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