Clinical Studies Management and Support

Added: Sep 17, 2015 10:47 am Modified: Oct 27, 2015 1:31 pmTrack Changes 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. NHLBI anticipates the issuance of a request for proposals (NHLBI-CSB-AR-2016-19-CM) on or about October 27, 2015 titled Clinical Studies Management and Support.

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.

Added: Oct 27, 2015 11:14 am The solicitation to the subject requirement is hereby posted.

Added: Sep 17, 2015 10:47 am 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. NHLBI anticipates the issuance of a request for proposals (NHLBI-CSB-AR-2016-19-CM) on or about October 2, 2015 titled Clinical Studies Management and Support.

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.

This announcement is not a request for proposals (RFP) and, although one award is anticipated, the Government is not committed to award a contract pursuant to this announcement. 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.