Request for Information (RFI) - Clinical Studies Management and Support
Added: Apr 17, 2015 3:04 pm
Request for InformationClinical Studies Management and Support PURPOSEThe National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) is soliciting input from potential Offerors and other interested parties to help inform the Institute about innovative ways to enhance its clinical studies management/support requirement for the Extramural Program (EP). This special notice is in advance of a Request for Proposal (RFP) solicitation planned to be issued during the fourth quarter of 2015.The overall purpose of the NIAMS Clinical Studies Management and Support requirement is to provide scientific and technical support in the conduct of clinical research funded by the Institute. The NIAMS is interested in receiving ideas from potential Offerors which will aid in the design of a future solicitation. The Institute welcomes ideas from leaders in the field of clinical research management support that will enhance its clinical research management operations.BACKGROUNDAs part of its research mission, The National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) supports clinical research on the cause, incidence, prevalence, prevention and treatment of arthritis, musculoskeletal, and skin diseases and disorders. These extramural-funded studies are supported by grants, cooperative agreements and contracts and include research of diverse study design, clinical setting, size and complexity.The NIAMS extramural program clinical research portfolio covers a range of clinical efforts. Studies include very early phase, short-term, pilot evaluations involving few participants at a single-site, to more robust, long-term, multi-site studies involving several hundred participants. Studies could include preventive and therapeutic interventional clinical trials as well as observational clinical studies. Given the diverse range of studies in the NIAMS clinical portfolio, there is special attention given to the varying degrees of risk to participants. The risk, as well as the scope and complexity of the research influences the safety monitoring required by the NIAMS to monitor these studies. The NIAMS is committed to funding clinical research which is conducted in the most scientifically valid, safe, and efficient manner possible. In an effort to enhance its clinical management operations, the NIAMS would like interested parties to offer their ideas relating to the latest advances in the field of clinical research management and support.QUESTIONS FOR CONSIDERATIONThe NIAMS invites interested parties to respond to the following:1. Describe an unmet need in clinical research management and support operations and how addressing this need could improve an organization's ability to effectively manage its clinical studies? 2. What are the technological innovations and capabilities required for sharing clinical trial data? What are the limitations and costs of providing a system for data sharing?3. What are the most critical areas to consider for developing a state-of-the art clinical management and support contract? Responses should include but need not to be limited to these areas:a. Study design and protocol writing and study materials developmentb. Statistical design, analysis, and reportingc. Clinical site monitoringd. Safety monitoring committees/oversight e. Data managementf. Regulatory supportg. Information management systems for tracking progress for clinical studiesInformation Submission Instructions All responses must be submitted via email to Cornelius Moore at mooreco@nhlbi.nih.gov by 4 PM on May 12, 2015. Responses are limited to 5 pages and must be submitted via a Microsoft Word document (.doc or .docx) or a non-image created PDF.Please include the Notice number in the subject line. Response to this RFI is voluntary. Responders are free to address any or all of the categories listed above.DISCLAIMER AND IMPORTANT NOTESThis notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.CONFIDENTIALITYNo proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitations(s).
NHLBI-CSB-AR-2016-19-CM Department of Health and Human Services National Institutes of Health
4/17/15, 3:04 PM Clinical Studies Management and Support
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.
NHLBI-CSB-AR-2016-19-CM Department of Health and Human Services National Institutes of Health
9/17/15, 10:47 AM