SOURCES SOUGHT
B -- Data Management & Monitoring for NIDCR's Gene Therapy Clinical Trial
- Notice Date
- 4/24/2006
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- Reference-Number-NHLBI-PB(DE)-2006-182-GMC
- Response Due
- 5/5/2006
- Archive Date
- 5/20/2006
- Description
- The National Institutes of Health (NIH), The National Heart, Lung, and Blood Institute (NHLBI), Consolidated Operations Acquisition Center (COAC), for the National Institute of Dental and Craniofacial Research (NIDCR) is conducting a market survey to determine the availability and potential technical capability of small businesses to provide the services of an established research organization to provide overall safety monitoring to ensure conformance with FDA requirements and regulations as well as with other regulations related to the conduct of a gene therapy study. Experience monitoring either gene or biological therapy studies is required for this effort. This project involves the following activities: 1) Study Related Documents and Files, which includes: a Clinical Monitoring Plan prepared by the Contractor which should contain specifications for each type of monitoring visit to be performed by contractor?s staff to ensure data quality, data integrity, and conformance to regulatory requirements. Study Master / Regulatory File: established and maintained by the Contractor will include at a minimum copies of the protocol; amendments to the protocol; sample case report forms; sample informed consent form; training materials; all regulatory documents; site visit reports; serious adverse event reports; correspondence; etc. Study Related Documents prepared by the Contractor which includes: case report forms; logs for recording patient screening and enrollment activities; logs for recording drug accountability; and logs for tracking specimen and data shipments. Study Handbook prepared and maintained by the Contractor shall a study which will include a protocol summary; key study personnel contact information; instructions for ordering study supplies; detailed instructions for completion of each case report form; instructions for storage and transmittal of case report forms for data management; serious adverse event reporting procedures; pharmacy instructions; instructions for maintaining the drug accountability regulatory file; and Good Clinical Practice guidelines. 2) Study Visits, which will include: site initiation visits; interim monitoring visits; close-out visits; and telephone visits as dictated by the clinical monitoring plan. 3) Study Meetings will be held to review the overall status of the study including patient enrollment and follow-up, data quality and integrity; and regulatory requirements such as serious adverse event reporting. 4) Data Management Activities which includes: case report form design and printing; preparation of case report form completion instructions; preparation of the data management plan; database programming and database validation; edit check programming and validation of programming; case report form data entry; coding; data clean-up; database quality control and lock; and patient data confidentiality. 5) Statistical Activities includes: developing a statistical analysis plan; statistical programming using a standard statistical software package such as SAS; statistical analysis which involves preparing an interim statistical report based upon the statistical plan. 6) Data and Safety Monitoring Board (DSMB) shall be established and managed by the Contractor, in collaboration with the Project Officer. The DSMB will be responsible for routinely monitoring patient safety, adverse events, and data quality and integrity. The DSMB will be established and operated in compliance with the FDA?s draft guidance on data and safety monitoring. The acquisition is estimated to take thirty six months to complete, with an anticipated award date of September 1, 2006. This is a new requirement and there is no incumbent contractor. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 5541990, Other Professional, Scientific, and Technical Services, with a size standard of an average annual receipts of $6.0M over the last 3 years. There is NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals and submission of any information in response to this market survey is purely voluntary; the Government assumes no financial responsibility for any costs incurred. If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Web site address and telephone number as well as size and type of ownership for the organization, i.e., small business, Small Disadvantaged Business, 8(a), woman-owned, Historically Underutilized Business Zone (HUBZone) concern, Veteran, and/or Service-disabled Veteran; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. Organizations responding to this market survey should keep in mind that only focused and pertinent information is requested. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements to demonstrate that small business prime contractors can maintain labor, technical, and management control of the project, meeting the Limitation on subcontracting@ imposed on small business set-asides. Taking into account the magnitude of the scope of this effort, organizations also should address the capacity of their financial infrastructure to deliver contract performance. Although no geographic restriction is anticipated, if responding organizations are located outside the Washington Metropolitan area, indicate how the organization would coordinate with the agency program office to provide support to multiple sites. The Government will evaluate the capability information using the following criteria: 1) Understanding the Requirement and Technical Approach which provided documentation of the scientific, technical, or analytical approach to achieve project objectives, including a demonstrated understanding of potential problems; 2) Qualifications and Availability of Proposed Personnel which includes demonstrated evidence of the qualifications, experience, and availability of professional and technical personnel comprising the necessary project staff; and 3) Proposed Facilities and Equipment which detail availability and proposed utilization. Interested firms responding to this market survey are encouraged to structure capability statements in the order of the area of consideration noted above. Responding firms should provide three (3) copies of a tailored capability statement to the National Heart, Lung and Blood Institute, Consolidated Operations Acquisition Center, Procurement Branch, 6701 Rockledge Drive, Suite 6042, Bethesda, MD 20892-7902, Attention: Debra C. Hawkins within ten (10) calendar days from the date of publication of this notice or not later than May 5, 2006, 12:00 noon. The response must reference number: NHLBI-PB-(DE)-2006-182/GMC. This market survey is being conducted through the FedBizOpps to reach the widest possible audience and to gather current market information.
- Place of Performance
- Address: Bethesda, Maryland
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN01033745-W 20060426/060424220255 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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