Request for Information (RFI) - Clinical Studies Management and Support

Added: Apr 17, 2015 3:04 pm Request for Information

Clinical Studies Management and Support

PURPOSE

The 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.

BACKGROUND

As 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 CONSIDERATION

The 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 development
b. Statistical design, analysis, and reporting
c. Clinical site monitoring
d. Safety monitoring committees/oversight
e. Data management
f. Regulatory support
g. Information management systems for tracking progress for clinical studies

Information 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 NOTES

This 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.

CONFIDENTIALITY

No 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).