ATTACHMENT3-StatementofWork_30JAN2020.pdf

RFP Clinical Central Laboratory Services ATTACHMENT 1 Statement of Work 1OCT2019 Page 1 of 4

RFP-NIAID-DMID-75N93020R00004

ATTACHMENT 3: STATEMENT OF WORK

CLINICAL CENTRAL LABORATORY SERVICES

RFP-NIAID-DMID-75N93020R00004

1) BACKGROUND and INTRODUCTION

Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to study, control, and prevent diseases caused by all infectious agents. This includes basic, clinical, and applied research to develop and evaluate therapeutics, vaccines and diagnostics that are funded through a variety of research grants and contracts.

The evaluation of new and improved vaccine, diagnostics and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of the NIAID. The Vaccine and Treatment Evaluation Units (VTEU), supported by the NIAID since the 1960’s, have designed and conducted a broad range of clinical studies and clinical trials of bacterial, viral and parasitic vaccines, therapeutics, and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. These have included Investigational Device Exemption (IDE), Investigational New Drug (IND) and non-IND trials, many Phase I first in-human clinical trials, and Phase II proof-of-concept trials. The VTEUs have also undertaken a variety of other studies, including: targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery.

The VTEUs also have an important role in responding to emerging public health needs at the direction of NIAID. There are approximately 75 active clinical trials per year in the VTEUs. Several of these clinical trials/studies were performed to address emergent public health needs, such as the zika and yellow fever outbreaks.

The VTEUs conduct clinical studies and Phase 0 through Phase IV clinical trials related to infectious diseases in a variety of domestic and international populations. These populations include healthy volunteers from birth to mature adults, pregnant women and subjects with endemic diseases for the specific international location. Many clinical trials conducted in the VTEUs are multi-center trials. When data is collected from multiple local laboratories that use different testing methodologies, reference ranges, and standard operating procedures, difficulties in data interpretation and delays in study timelines may result. A need for a clinical central laboratory, a laboratory that will process all screening and safety labs collected at all sites participating in one trial, has been identified.

The contract(s) to be awarded in relation to this Statement of Work (SOW) will provide clinical central laboratory services. The NIAID anticipates awarding multiple Indefinite Delivery Indefinite Quantity (IDIQ) contracts to fulfill the technical requirements of this SOW. However, the NIAID reserves the right to award a single award IDIQ. All projects carried out under the contract must be conducted in a manner consistent with all applicable Federal and local regulations, DMID, NIAID, NIH and DHHS policies and guidelines.

2) SCOPE AND TASK ORDER ACTIVITES:

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DMID may conduct clinical trials in domestic and international locations. The Contractor shall perform clinical laboratory screening and safety testing to support multi-center clinical trials.

For Task Orders issued under the IDIQ(s), the Government would issue a Request for Task Order Proposal (RTOP) after determination of a specific need. The Contractor shall develop and submit a proposal in response to individual RTOPs, as they are issued, that specifies the methods it will employ in accomplishing the key components of each Task Order.

3) TECHNICAL REQUIRMENTS

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work. All technical requirements in the parent IDIQ contract will govern the Task Order(s), as well.

The Contractor will provide services and supplies, that will include the following:

A. Overall Administration and Project Management Support

1. Project management to include study set-up, ongoing management and support, and proactive identification and prompt resolution of issues.

2. Organize teleconferences and meetings with DMID and appropriate parties as needed to facilitate contract initiation and issue resolution.

B. Technical Requirements

1. Laboratory Testing

• Receive clinical samples from clinical sites;

• Perform testing of clinical samples, in accordance with the SOPs developed by the Contractor;

• Retain unused samples under appropriate conditions for retesting, if necessary; and

• Provide quality control and global standardization of equipment, processes, controls and calibration.

2. Clinical supply kits, investigator manuals and shipping supplies.

3. Courier services and tracking for initial supply shipments and re-supply shipments.

4. Courier services and shipment tracking for clinical specimens.

• Courier will pick up clinical specimens from the clinical site the same day that the samples are drawn and deliver them to the laboratory for testing within 24 hours;

• Shipments shall be temperature controlled, as necessary;

• The Contractor shall provide shipping insurance, if requested in the Task

Order; and

• All shipments shall be made according to Federal regulations and the

International Air Transport Association (IATA) requirements for the shipment of dangerous goods (http://www.iata.org/whatwedo/cargo/dangerous_goods/Pages/index.asp http://www.iata.org/whatwedo/cargo/dangerous_goods/Pages/index.aspx

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x), in accordance with cGLP and cGCP regulations, and in compliance with domestic and non-domestic laws and regulations.

5. Provide documents, such as investigator manuals and study-specific lab requisitions.

6. Investigator training, with slides, via teleconference, webinar or attendance at the Investigator Meeting.

7. Investigator assistance/support, including the use of toll-free phone lines.

8. Cumulative data transmissions sent to the Statistical Data and Coordinating

Center (SDCC) daily, weekly or monthly, as described in the Task Order.

The SDCC is responsible for the operation of a central data management system for the receipt, storage, tracking and retrieval of all clinical and laboratory data, and for implementing quality assurance/quality control procedures to ensure the accuracy, completeness and timeliness of data for clinical trials.

Only the results for requested tests should be included in the data transfer.

An entire panel should not be reported, unless requested in the Task Order.

9. Data management support to include maintenance of the results database, query resolution, prompt issue resolution and documentation of data revisions.

10. Confidentiality of all study related information provided to Contractor and test results generated under the contract.

11. Maintenance of current Clinical Laboratory Improvement Amendment certification (http://www.cms.gov/clia) and other certifications as appropriate.

12. Ensure that work conforms to standards acceptable for regulatory submissions.

(http://www.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/Page s/default.aspx)

13. Access to all necessary personnel, facilities, equipment and records for independent audits and monitoring. Develop, implement and comply with corrective and remedial actions resulting from NIAID independent audits.

C. Facilities, Equipment and Other Resources

Provide, operate and maintain all facilities, equipment, and other resources necessary to carry out the functions specified in the Statement of Work and in the Task Orders issued under the IDIQ, as required by the protocol.

The Contractor shall carry out the Scope and Activities defined in this Statement of Work.

Task Order(s) may be comprised of either one (1) Protocol or a combination of multiple Protocols. Agency CORs will provide technical direction to the Contractor in all awarded Task Orders. Technical Requirements will be defined in each individual Task Order.

http://www.iata.org/whatwedo/cargo/dangerous_goods/Pages/index.aspx http://www.cms.gov/clia http://www.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/Pages/default.aspx http://www.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/Pages/default.aspx

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[END OF STATEMENT OF WORK FOR THE PARENT CONTRACT]