Description
This Small Business Sources Sought Notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. The National Institutes of Health (NIH) National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) is conducting a market survey to determine the availability and technical capability of qualified small business, veteran-owned small business, service-disabled veteran-owned small business or HUBZone small businesses capable of providing services as Clinical Islet Transplantation (CIT) Consortium the Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM) with the oversight and management of clinical trials and large-scale epidemiological studies in diabetes, endocrinology and metabolism. Responsibilities : Prepare documentation of procedures for clinical trials management and data safety monitoring board to meet the needs of DEM, NIDDK, NIH, and the researchers with whom they work as well as consumers, the federal government, or special interest groups. Prepare and maintain Investigational New Drug Applications and Investigation Device Exemption applications. In coordination with the Coordinating Center, if applicable, assist Program Officials with initiation and management of Data and Safety monitoring Boards (DSMB) and Scientific Advisory Boards (SAC). Assist Program Officials in the interface with the Office of Technology Development and Transfer. Assist Program Officials in development of new or modified study protocols and informed consent documents. Qualifications : Master degree or equivalent in a field relevant to health sciences research; At least 5 years of experience in clinical trials oversight or equivalent; Evidence of skill in technical writing related to clinical trials; Ability to organize and carry out multiple concurrent long term projects; Experience with helping prepare regulatory submissions to the FDA and oversight submissions to a DSMB; Experience in reviewing consent documents and assisting clinical sites in preparing and submitting IRB documents; Experience with human islet transplantation trials, including study design issues, informed consent issues and regulatory requirements; Experience with coordinating efforts in multi-center phase I-II and phase III (pivotal) clinical trials between clinical sites, the coordinating center and two or more Institutes at the NIH; Must be available for U.S. and International travel to visit clinical trial sites. Interested firms with the capability of providing the required service listed above are requested to submit a capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurement will be classified under North American Industrial Classification (NAICS) code 561320 with a size standard of $12.50. All respondents are requested to identify their firm's size and type of business. Interested firms responding to this market survey must provide (a) capability statement demonstrating their experience, skills and capability to fulfill the Government's requirements for the above. The capability statement shall be in sufficient enough detail, but not to exceed 15 pages, so that the Government can determine the experience and capability of your firm to provide the requirements above. Your capability statement, not to exceed 15 pages, should include references. Two copies of the capability statement must be received at the address identified in this synopsis by February 21, 2013 no later than 11:00 A.M. local time at designated location). Responses by fax or e-mail WILL NOT BE ACCEPTED . This synopsis is for information and planning purposes and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited. 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 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 provided feedback to respondents with respect to any 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 response to a solicitation.