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Clinical Research Auditing

Solicitation Number: NIAID-DAIDS-NIHAI2008050
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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NIAID-DAIDS-NIHAI2008050
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Solicitation
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Added: Nov 26, 2008 3:31 pm
The Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS, as the Investigational New Drug (IND) Application sponsor for a large number of DAIDS-funded clinical trials, has a requirement to monitor clinical trials to ensure compliance with DAIDS, domestic and country-specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical trial data, and assess adherence to protocol-specific requirements.

The Contactor shall provide (1) quality assurance auditing of the performance of clinical site monitoring functions for NIAID/DAIDS-supported domestic and international clinical research sites and protocols and, (2) independent for cause auditing of clinical research sites. The scope of activities to be performed by the Contractor shall include: 1) development and implementation of Standard Operating Procedures (SOPs) specific to each of the two main auditing functions; 2) development and implementation of audit plans specific to each of the two main auditing functions; 3) conduct of the following audits: (a) audits of completed routine and specialized clinical site monitoring visits performed by the clinical site monitoring contractor/entities, and audits of completed remedial and for cause clinical site monitoring visits performed by the clinical site monitoring contractor/entities; (b) independent for cause audits of clinical research sites; and (c) It is anticipated that 48 audits per year will be performed between domestic and international sites. This is estimated at 60 percent international and 40 percent domestic; 4) preparation of comprehensive auditing reports and Corrective and Prevention Action (CAPA) Plans; 5) development and implementation of a training plan for auditors; 6) coordination and collaboration with other clinical research support contractors and clinical research networks and sites; 7) operation and maintenance of a database of contract-generated reports and other information/materials; 8) development and implementation of an internal Quality Assurance/Quality Control (QA/QC) Plan and an Integrated Master Project Plan; and 9) ability to expand staffing from the base period if any of the options are exercised as directed by the Government.

Technical proposals will be evaluated based upon the following criteria: 1) The appropriateness, adequacy, soundness and feasibility of proposed plans and procedures and capabilities for carrying out the functions specified in the Statement of Work; 2) The suitability and adequacy of the qualifications, experience, training, and availability of proposed clinical and technical personnel to accomplish the requirements specified in the Statement of Work, particularly with respect to large and complex clinical trial programs involving both domestic and foreign clinical sites, including clinical sites in resource-limited countries; 3) The adequacy and availability of the proposed facilities, equipment and other resources necessary to carry out the functions specified in the Statement of Work; 4) The adequacy and appropriateness of the training, experience, qualifications and availability of the proposed project management personnel, particularly with respect to the coordination, management and oversight of quality assurance auditing of the performance of clinical site monitoring functions for large and complex clinical trials programs involving both domestic and foreign clinical sites, including clinical sites in resource-limited countries; and 5) The appropriateness, adequacy, feasibility and soundness of the proposed Integrated Master Project Plan with respect to Management Structure and Project Implementation and Management.



It is anticipated that one cost reimbursement level of effort type contract will be awarded for a base period of one year on or about February 4, 2010. In addition to the above functions and services to be provided for the Base Period, up to 82 Options for expanded services under the contract may be exercised at the discretion of the Government. These Options are defined as follows: Options 1-6 are for additional years; Options 7-34 are for increased level of effort and Options 35-82 are for expanded audits of the performance of Clinical Site Monitoring functions.

The NAICS Code is 541712 with a size standard of 500 employees. All responsible small business may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about December 11, 2008, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

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Solicitation 1

Type:
Solicitation
Posted Date:
December 11, 2008
Description: Solicitation for RFP Number: NIAID-DAIDS-NIHAI2008050.

Amendment 1

Type:
Mod/Amendment
Posted Date:
February 24, 2009
Description: AMENDMENT NO. 1, NIAID SOLICITATION NO. NIAID-DAIDS-NIHAI2008050
“NIAID/DAIDS Clinical Research Auditing”

Amendment 2

Type:
Mod/Amendment
Posted Date:
April 9, 2009
Description: Amendment 2

Amendment 3

Type:
Mod/Amendment
Posted Date:
April 22, 2009
Description: AMENDMENT No. 3

Amendment 4

Type:
Mod/Amendment
Posted Date:
May 29, 2009
Description: Amendment 4 to Solicitation NIAID-DAIDS-NIHAI2008050
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United States and International

United States
:
Jason Bell,
Contract Specialist
Phone: 301-496-0612
Fax: 301-480-4675
:
Michelle A Scala,
Contracting Officer
Phone: 301-451-3693
Fax: 301-480-4675