Protocol Monitoring and Data Management Support Services

Added: Aug 31, 2017 11:37 am Introduction

This is a pre-solicitation non-competitive (notice of intent) synopsis to award a purchase order without providing for full and open competition. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), on behalf of the National Human Genome Research Institute (NHGRI), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Emmes Corporation, 401 N. Washington Street, Suite 700, Rockville, MD 20850-1785 to provide protocol monitoring and data management support services to the NHGRI Office of the Clinical Director (OCD) in accordance with the following information.

Background Information

The National Human Genome Research Institute (NHGRI), Division of Intramural Research (DIR) was established to serve as a hub where development of technology for the rapid isolation and analysis of disease genes will be carried out. The OCD focuses on finding new and better ways to help patients affected by genetic disorders. To that end, the office provides oversight and guidance to NHGRI scientists working to develop better diagnostic methods, innovative therapeutic approaches and improved medical management strategies for genetic disorders.

Purpose and Objectives

The purpose of this acquisition is to provide protocol monitoring and data management support for NHGRI's intramural clinical trials.

Contractor Requirements

The contractor shall:

• Manage the NHGRI Clinical Director's intramural monitoring and quality assurance program.
• Establish, update and implement the SOP for protocol monitoring and quality assurance.
• Prepare and enforce corrective and preventative action (CAPA) plans.
• Lead NHGRI clinical staff training for FDA-regulated clinical trials; prepare informational materials for training; educate clinical staff on human research protection policy updates.
• Verify data from NHGRI intramural clinical trials; verify NIH Clinical Center Pharmacy inventory records.
• Prepare regulatory documentation and official binders for NHGRI intramural clinical trials.
• Manage the NHGRI Clinical Director's program for submitting data to the national registry and results database of clinical studies of human participants (ClinicalTrials.gov).
• Perform data and statistical analysis to prepare clinical trial data for submission to ClinicalTrials.gov; prepare informational materials on clinical trials for use on ClinicalTrials.gov.
• Serve as liaison to regulatory offices and agencies, including the NIH Office of Human Subjects Research Protections, the NIH Office of Intramural Research, the NHGRI Institutional Review Board, the NHGRI Bioethics Core, the National Library of Medicine and the NIH CC Office of Protocol Services.
• Contribute to and participate in OCD policy activities for human research protection and clinical trial management.
• Perform data management for small NCI-CTEP-sponsored study -
o Create and submit quarterly report to CTEP (via CDUS);
o Extract and summarize trial data from clinical records;
o Work with staff on tracking and reporting of adverse events;
o Complete case report forms;
o Create and maintain spreadsheets for data analysis;
o Maintain regulatory-compliant study database; and,
o Work with staff on data for regulatory reporting (sponsor, FDA, DSMB).
• Perform data management for other NHGRI clinical protocols -
o Work with staff on database creation for NHGRI protocols, primarily in the NICHD-based Clinical Trials Database (CTDB);
o Enter old study data into CTDB (back-data entry); and,
o Act as intermediary between investigators and CTDB staff for creating, modifying and maintaining study databases.

Period of Performance

The period of performance will be six (6) months from date of contract award.

Sole Source Justification

Emmes Corp. is uniquely equipped with all the required resources to provide the requested services. The tasks related to this project are a follow-on to an existing award with Emmes and they have the necessary network and personnel to successfully achieve all deliverables which allows for continuity in the completion of the work and the final product. It would be detrimental to the Government to and experiments in progress should another contractor take on these services in the middle of the project. The time and effort to train a new contractor would cause in a severe loss of data.

Emmes offers a full range of (1) clinical research services, including clinical research management, statistical design and analysis, protocol development and data management, clinical site management, pharmacovigilance services, quality assurance, and regulatory affairs support; (2) specialty services, including Data and Safety Monitoring Board services, Prime Review Board Services, and Ophthalmic Training and Certification; (3) IT and analytical solutions, including bioinformatics, imaging, and website services; and (4) integrated clinical trial management through Advantage eClinical, their unified clinical trials platform. Emmes can comprehensively apply these services to provide leadership and support for the current request for protocol monitoring and data management support services and further scope as applicable after the protocol is finalized. Emmes will assign a dynamic team of qualified personnel who have experience and clinical trial design and regulatory expertise.

Regulatory Authority

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, or industrial mobilization).

FAR Clauses

The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition.

The provision at FAR clause 52.212-2, Evaluation - Commercial Items, is applicable. The Government will award a contract resulting from this notice to the offeror listed above. The following factors shall be used to evaluate the offer: The contractor shall demonstrate its ability to provide the above listed equipment that meet the required specifications listed.

FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition.

Additional Information

The North American Industry Classification System (NAICS) Code is 541611 and the Small Business Size Standard is $15.0M. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-95 (January 19, 2017).

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. 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. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by September 7, 2017 at 12:00PM EST and must reference synopsis number HHSN26817HG00035S. Responses shall be submitted electronically to john.lear@nih.gov. Responses will only be accepted if dated and signed by an authorized company representative. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.