Statement of Work.pdf
PDF 120 KB Posted
- Attached to
- Pre-Clinical Consulting Services
- Solicitation number
- 75N95025Q00127_SB
About this file
This Statement of Work outlines services required by the National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trials Unit (CTU) for consultant expertise in clinical research and pre-clinical development. The CTU supports over 120 clinical research programs and requires broad expertise for IND and IDE-enabling pre-clinical development initiatives.
The consultant must have experience working with multiple stakeholders including the American Society for Experimental Therapeutics (ASENT), pharmaceutical industry, academics, and expertise in clinical research regulatory and gene-therapy domains. Services will be performed virtually through NINDS IT resources at the Bethesda campus, MD. The timeframe is to be determined (TBD), and Dr. Lauren Reoma or Mr. Bradley Alvarez will serve as the NINDS points of contact. This requirement supports the CTU's mission to ensure quality practice in NINDS intramural research programs and advance clinical trial methodology through collaborations with internal and external partners.
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| File | Type | Posted |
|---|---|---|
| B. Sources Sought Notice - (SB).pdf |
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Text version
DEPARTMENT OF HEALTH & HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke
STATEMENT OF WORK SERVICES & REPAIRS
Background & Justification:
As a core unit under the NINDS Office of the Clinical Director, the Clinical Trials Unit (CTU) supports and facilitates clinical research at the NINDS intramural research program, by providing assistance and resources during all phases of the life cycle of a protocol, from protocol development to start-up and execution, to data analysis and reporting.
It is the goal of the NINDS CTU to ensure quality of practice in the NINDS intramural research programs through oversight of clinical research conducted by NINDS intramural investigators and the provision of education and training opportunities to all members of clinical research study teams. The NINDS CTU is furthermore dedicated to promoting the advancement of clinical trial methodology through research collaborations with clinical investigators at NINDS as well as outside partners, including industry, government, academia, and patient advocacy organizations.
Services to be performed / Statement of Need:
As a core unit supporting more than 120 clinical research programs through the NINDS Office of the Clinical Director, the CTU requires broad expertise from multiple stakeholders and subject matter experts. As part of the program development supporting NINDS as Sponsor for more than a dozen IND and IDEs, the CTU also requires consultant expertise in areas pertaining to IND and IDE-enabling pre-clinical development. This consultant expertise should be able to comment on and have experience in multiple domains that the CTU and it’s stakeholders engage in – including working with partner organizations such as the American Society for Experimental Therapeutics (ASENT), the pharmaceutical industry, academics, as well as having experience pertaining to clinical research regulatory and gene-therapy domains.
Quote/Estimate or Service Agreement number:
N/A
Location where the services will be performed:
NINDS Intramural Clinical Neurosciences Program (virtual) Bethesda campus, MD
When the service will be performed? :
TBD
How will the service be performed? :
The services will be performed and shared collaboratively through NINDS IT resources in a virtual environment
Who is the designated NINDS Point of Contact for this Service order?
Dr. Lauren Reoma (or Mr. Bradley Alvarez)
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