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This Solicitation opportunity was posted on November 23, 2015. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Clinical Studies Management and Support

Closed
NHLBI-CSB-AR-2016-19-CMFederal

Contract Overview

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The National Heart, Lung, and Blood Institute, acting for the National Institute of Arthritis and Musculoskeletal and Skin Diseases, is seeking a Clinical Research Organization to provide comprehensive technical and regulatory management for its portfolio of clinical research studies. This research and development service contract covers the entire lifecycle of clinical trials from inception to completion. Key responsibilities include document development, data and safety monitoring committee support, clinical site monitoring, biostatistical review, regulatory consultation, GCP training, and the implementation of electronic data management systems. The project is intended to span 60 months, with a Cost-Reimbursement-Completion contract type under consideration. This acquisition is specifically set aside for small business concerns under NAICS code 541712. Interested parties are responsible for obtaining the Request for Proposal and monitoring for amendments via the official government procurement website.

General Info

Agency

N/A

Contract Value

$1,704,876

NAICS

541712 - Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Award Issued Date

Documents

0

No documents available

Documents will appear here when they are available.

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Uniform Contract Format

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Timeline

4 updates
PhaseClosed
Posted

special-notice

Notice updated

The notice title changed. The notice description changed.

Notice updated

Notice type changed from Special Notice to Presolicitation. Response deadline changed from May 12, 2015 to Oct 2, 2015. The notice title changed. Set-aside added: Total Small Business Set-Aside (FAR 19.5). The notice description changed. The point of contact changed.

Notice updated

Response deadline changed from Oct 2, 2015 to Dec 10, 2015. Set-aside removed. The notice description changed. The point of contact changed.

Notice updated

The notice description changed.

Type Changed

Presolicitation → Solicitation

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyN/A
Contacts2 people available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
Janet MattsonContracting Officer - Team Lead

Full Description

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The National Heart, Lung, and Blood Institute on behalf of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is seeking an organization with expertise in clinical research management and support functions to provide technical and regulatory expertise in the management and oversight of the Institute's portfolio of clinical research studies/trials. This is a research and development service contract that will be used to assist the Institute with the oversight and management of its clinical research studies/trials. The services will include the necessary operations needed to execute clinical research studies/trials from study inception to completion. Examples of these services include but are not limited to; clinical study document development and review; data and safety monitoring committee management and support; logistical and executive secretarial support for meetings; clinical site monitoring and study assessment; biostatistical review and consultation; regulatory support and consultation; GCP training for NIAMS staff and Investigators; and the development of electronic systems for managing clinical study information/data. The ideal Offeror for this solicitation would be a Clinical Research Organization (CRO) with diverse experience in all of the above areas. The requirement will cover 60 months and a "Cost-Reimbursement-Completion" type contract is being considered. The ultimate contract type and funding mechanism will be determined by NHLBI, based on what fits the project goals and the available funding. The RFP will be available on the FEDBIZOPPS website at http:fedbisopps.gov. Potential Offerors are responsible for downloading the RFP and any/all attachments. It is also the Offerors responsibility to monitor the FEDBIZOPPS for any amendments to the RFP. It has been determined that this acquisition will be set aside for small business concerns under the North American Industry Classification System (NAICS) code 541712.

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