Loren Data's SAM Daily™

FBO DAILY ISSUE OF FEBRUARY 15, 2012 FBO #3735
SOURCES SOUGHT

A -- Clinical Coordinating Hub for NHLBI Engine for Fast Execution of Clinical Trials (EFFECT)

Notice Date

2/13/2012
 

Notice Type

Sources Sought
 

NAICS

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

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
 

ZIP Code

20892-7902
 

Solicitation Number

HHS-NIH-NHLBI-SBSS-HR-13-20
 

Archive Date

8/13/2012
 

Point of Contact

Sara Stoops, Phone: 301-435-0329, Jenn Malkin, Phone: 3014350339
 

E-Mail Address

stoopssb@mail.nih.gov, malkinje@nhlbi.nih.gov
(stoopssb@mail.nih.gov, malkinje@nhlbi.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under NAICS code 541712 should not submit a response to this notice. Background The NHLBI is seeking a small business with the ability to serve as the Clinical Coordinating Hub (CCH) for a new seven-year program, the NHLBI Engine for Fast Execution of Clinical Trials (EFFECT). The CCH will execute one or more Clinical trials in patients with serious pulmonary disease, especially patients requiring hospitalization for acute exacerbations (AE) of Chronic Obstructive Pulmonary Disease (COPD). The CCH will recruit and train 30-50 Clinical sites (CS), including academic institutions and other healthcare delivery centers like practice-based networks, HMOs, and CTSAs. From these CS the CCH will establish a virtual network that can be rapidly configured and activated to conduct a selected trial. Up to 5 foreign Sites may be allowed. The CCH will have strong expertise in pulmonary medicine, clinical trial design and simultaneous conduct of multiple trials operations, data management, and biostatistics for a period of up to seven years. Each of the CS recruited by the CCH will have a Principal Investigator responsible for the conduct of the trial at the site. The CCH will have a supervisory role on the conduct of the trials at each CS and will report to NHLBI. CS will also be responsible for collecting and shipping to the CCH high quality biospecimens that will permit the molecular analysis of disease pathogenesis and disease stratification in patients with AE of COPD. The trials of EFFECT will test a medical intervention in Phase II or Phase III efficacy, effectiveness, or comparative effectiveness trials. Project Requirements The CCH is expected to fulfill the following: 1) Experienced and highly competent in the coordination of complex studies involving hospitalized patients with severe pulmonary diseases, especially COPD. 2) The PI of the CCH will have demonstrated expertise and leadership in biostatistics and clinical trial design and conduct in patients with severe pulmonary diseases, especially COPD as also attested by her/his publication record. 3) The CCH co-investigator will have demonstrated experience in clinical trials and be certified and actively involved in the care and study of pulmonary and hospitalized patients with severe pulmonary diseases, especially COPD. 4) Propose two protocols involving approximately 500-700 subjects, to test the efficacy of medical interventions designed to prevent readmissions at 30 days in COPD patients hospitalized for an acute exacerbation. 5) Describe plans to solicit the pulmonary medical community at large for the submission of additional clinical trials in hospitalized patients with severe pulmonary diseases, especially COPD. 6) Prepare final protocols for review by the Protocol Review Committee (PRC) and the Data and Safety Monitoring Board (DSMB). 7) The CCH will develop plans for: a. randomization of subjects, b. preparation and distribution of protocols, manuals and forms, c. data collection, quality, completeness, confidentiality, and analysis, d. training of the CCH and the CS staff in implementing protocols and data entry, e. methods to audit site data accuracy and quality, f. preparing and reporting of data and protocols to the Steering Committee (SC), PRC and DSMB, g. coordinating drug blinding and distribution, as necessary, h. assisting with the development of efficient IRB reviews by the many CS, i. monitoring content of and IRB approval of informed consent forms, j. assisting in preparation of final manuscripts of primary studies, k. coordinating communications among the CS and scheduling conference calls and meetings of trial committees, as needed, l. organizing (and PIs will attend) meetings of the PRC and DSMB, 8) Experienced in working with the FDA to obtain approvals for new drugs and/or devices. 9) Responsible for developing a plan to lead biospecimen collection by sites and storage at a central lab. 10) Responsible for leading the CS in the development of a more efficient Institutional Review Board (IRB) review process. This could be a collaborative IRB, a central IRB or some other method that will increase efficiency of trial reviews while maintaining safety and quality. 11) Collaborate with the CS to develop and distribute an Operations Manual detailing procedures for a) collection of data, entry, and transmission of data to the CCH and b) data quality control/assurance procedures. 12) Develop Section 508 compliant computer systems and software needed to collect clinical data at the bedside, to transfer clinical data from the CS to the CCH, and for storage, retrieval, and statistical analysis of data. 13) Develop and operate a Section 508 compliant randomization system for each trial to ensure equal and unbiased distribution of patients into treatment groups. 14) Develop Section 508 compliant Network web sites (public and internal for the network) that include, but are not limited to, a) a description of the Network objectives, organization, procedures, protocols, and references to publications resulting from Network research trials and b) a link to the NHLBI public web site. 15) Maintain and enhance the Network web sites including a portal for outside investigators to submit research ideas and comments. 16) Plan and coordinate meetings and teleconferences of the SC, PRC, DSMB, and subcommittees as may be necessary. 17) Develop a tracking system for the CS IRB submission and review. As available, review each CS's IRB-approved consent form for adherence to required elements. Maintain a file of the most current consent form from each CC. Ensure receipt of the CSs' IRB approvals for each protocol and for annual reviews, as necessary. 18) Conduct scientific site visits and data quality/chart review site visits. 19) Provide data sets to the SC for preparation of publications of main trial results. Conduct statistical analyses of main trial results. 20) Prepare final limited access data sets. The data sets shall include data with full documentation, prepared in accordance with NHLBI policies available at: http://www.nhlbi.nih.gov/resources/deca/policy.htm Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each project requirement separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The capability statement must not exceed 15 single sided or 7.5 double sided pages in length (inclusive of any appendices) and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Sara Stoops, Contracting Officer, at stoopssb@nhlbi.nih.gov and Jenn Malkin, Contracts Specialist, at jenn.malkin@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-SBSS-HR-13-20/listing.html)
 

Place of Performance

Address: National Heart, Lung and Blood Institute, NIH, 6701 Rockledge Dr RKL2/6016 MSC 7902, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN02674244-W 20120215/120213235850-a4d15b4d97fbcf40714ed3f87783bd80 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |