B -- Data Management and Monitoring for NIDCR's Gene Therapy Clinical Trial

THIS IS A 100% SMALL BUSINESS SET ASIDE. 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. 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) has a requirement for 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 Government will evaluate proposals 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. The award of a fixed-price, labor hour type contract is anticipated. The solicitation will be released on or about June 23, 2006 with a due date on or about July 23, 2006. Interested parties should submit a written request via mail or facsimile transmission to (301) 480-3345 for a copy of the solicitation number NHLBI-PB(DE)-2006-182-GMC to the National Heart, Lung, and Blood Institute, Office of Acquisitions, Procurement Branch, 6701 Rockledge Drive, Rockledge Building 2, Room 6146, Bethesda, Maryland 20892-7902, Attn.: Gina M. Cianflone, Contract Specialist. All responsible sources may submit a proposal, which if timely received, shall be considered by the Government. The acquisition is estimated to take thirty six months to complete, with an anticipated award date in September 2006. This is a new requirement and there is no incumbent contractor.