R -- CLINICAL MONITORING AND OVERSIGHT FOR THE VACCINE RESEARCH CENTER

Notice Date

August 17, 2001

Contracting Office

Acquisitions Management Operations Branch, NIAID, 6700-B Rockledge Drive, Room 1130, Bethesda, MD 20892-7605

ZIP Code

20892-7605

Solicitation Number

NIAID-VRC-01-59

Response Due

December 3, 2001

Point of Contact

Barbara Welsh, 301-496-3878 Contract Specialist, Karin E. Eddy 301-496-3878, Contracting Officer

Description

The Vaccine Research Center of the National Institute of Allergy and Infectious Diseases has a requirement for monitoring and clinical oversight services for approximately 10-12 Investigational New Drug Applications (IND) encompassing up to 20 clinical trials of vaccine products per year. Support will include but not be limited to: IND preparation, clinical site monitoring, and logistical support for the clinical program. This support will be supplied in accordance with regulatory guidance and requirements provided by the FDA, NIH and other regulatory agencies. Clinical trials conducted by the VRC will involve up to approximately 200 new volunteers per year. The vaccine strategies will include the use of a variety of biological agents including but not limited to genetically engineered or virus-derived agents. Understanding regulatory guidelines for dealing with regulatory concerns and handling requirements for biological agents is an important consideration. This requirement also calls for interaction and cooperation with other VRC supported contracts. In order to assure timely and accurate submission of information to the FDA, and monitoring of ongoing clinical studies to ensure regulatory compliance, contractors must have the capacity to attend meetings at the VRC facility as needed on the NIH campus in Bethesda, Maryland. The RFP is divided into PARTS I, II and III. PART I and PART II constitute distinct and discrete services that cannot be shared by a single Contractor. PART III should be able to be performed by Both PART I and PART II Contractors. It is expected that multiple cost reimbursement, completion type contracts using work assignments will be awarded for this requirement. This is a full and open requirement. The RFP will be available on or about October 15, 2001. All requests MUST be in writing to Barbara Welsh, Contract Specialist, 6700 B Rockledge Drive, Room 1129, MSC 7605, Bethesda, MD 20892-7605.

Record

Loren Data Corp. 20010821/RSOL013.HTM (W-229 SN50V336)