22-001351

Submitted by whipple on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Remote Clinical Site And Study Monitoring Support Services
Contracting Office
National Institute of Mental Health (NIMH)

Contact Points

Primary Contract Specialist

Cheryl
Leone
cleone@mail.nih.gov

Secondary Contracting Officer

Maria Helena
Garcia
mariahelena.garcia@nih.gov
NAICS Code Number
541990
All Other Professional, Scientific, and Technical Services
Estimated Period of Performance
30 days from the date of award
Delivery of Goods
n/a
Competition Status
Non-Competitive
Vendor Name
PPD DEVELOPMENT, L.P.
Vendor Address
929 N Front ST
Wilmington, North Carolina
28401-3331

Single-Sole Source Determination
This notice of proposed acquisition is posted as an intent to award a purchase order on a non-competitive basis to PPD. The NIMH has determined that this vendor’s services have unique capabilities that are not available elsewhere in the marketplace.

This notice is not a request for competitive proposals.  However, interested parties may identify their interest and capability to respond to this notice.  

A determination by the Government not to compete this proposed action based upon responses to this notice is solely within the discretion of the Government.
  
Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.



Background/Description of Requirement
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: Additionally, the Contractor shall keep abreast and comply with all changes in Federal and country-specific requirements governing human subjects’ research, Good Clinical Practive (GCP) and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and NIMH policies and procedures. The Contractor shall: • provide remote clinical site and study monitoring support services for five (5) studies/sites; • develop one (1) draft monitoring report. The monitoring for five (5) studies/sites will include activities that may involve, but not limited to the review of subject level data, protocol adherence, adverse event reporting, staff training, etc. The project deliverables will be delivered in a timely manner. The services for remote clinical site and study monitoring support are expected not to exceed ninety-four (94) hours. The Contractor shall provide the following deliverables, status update meetings, and reports: • Provide remote monitoring for five (5) studies with activities that may involve, but not limited to the review of subject level data, protocol adherence, adverse event reporting, staff training, etc. • Review and documents, protocol(s), and other study related documents’ adherence to inclusion and exclusion criteria. • Review accuracy and completeness of reporting of protocol exemptions. • Review and document adherence to other protocol specific requirements. • Regulatory review to assess the adequacy of procedures for ensuring compliance with regulatory requirements. • Maintenance of appropriate source documentation. • Documentation of findings, including verification of endpoints. • Prepare a summary of results and write a draft monitoring report.

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.