National Institute on Aging (NIA) Clinical Trials Operations Support Center

See attached Amendment No. 2, for NIA response to questions regarding the solicitation. All other terms and conditions of the solicitation remain unchanged including the due date/time for receipt of PROPOSALS.

See attached Amendment No. 1, which provides the due date/time for receipt of QUESTIONS. All other terms and conditions of the solicitation remain unchanged including the due date/time for receipt of PROPOSALS. 

SOLICITATION FOR HHS-NIH-NIDA(AG)-RFP-16-019 ACQUISITION TITLED: "National Institute on Aging Clinical Trials Operations Support Center"

The National Institute on Aging (NIA), National Institutes of Health (NIH), Department of Health and Human Services (HHS) intends to re-compete a requirement currently being performed by KAI Research Inc. under NIA Contract HHSN271201200002I, under full and open competition procedures in FAR Part 15. . It is anticipated that a single cost reimbursement contract will be awarded for a one year base period and four (4) one-year option periods beginning on or about August 2017.

The purpose of this project is to continue operation of the CTOSC in order to provide support for the management, tracking, and oversight of clinical trials funded by the NIA. The Contractor shall provide clinical trial support in the interpretation and implementation of quality assurance guidelines for specific clinical studies; maintain the NIA Clinical Research Study Investigator's Toolbox, a web based informational resource for researchers ensuring data quality and integrity; train the clinical trial Principal Investigator (Pl) and staff on how to perform an internal audit or
other study monitoring activities; maintain the NIA Safety Training Course; review awardees clinical trial materials and reports to ensure participants safety and alert the NIA program staff about emerging safety concerns with studies, as well as recommend possible corrective actions to eliminate or decrease risks to study participants.

OBJECTIVES

The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, in order to serve as a CTOSC. The Contractor shall provide scientific resources and services necessary to support a broad range of activities required to effectively manage the NIA clinical trials, requiring advanced expertise in the design, conduct, analysis, and oversight of clinical trials. Seven (7) distinct performance areas have been identified and described in detail as follows: (1) Project Management; (2)
Clinical Trials Operations Support and Quality Assurance; (3) Safety-Related Operations Support; (4) Statistical and Methodological Consultation; (5) Training of NIA Staff in Clinical Trials Procedures; (6) Maintenance of the NIA Database on Human Intervention Studies; and, (7) Transition Plan and Contract Closeout. The Contractor shall provide Project Management planning and implementation services so that both the Contractor and NIA can monitor and manage activities in each of the above seven (7) performance areas. The project management
planning and implementation services will include the following requirements: (1) Annual Performance Plan, (2) Monthly and Annual Progress Reports, (3) Availability, and (4) Email and Internet Access. The Clinical Trials Operations Support and Quality Assurance performance area is to ensure that the data resulting from a trial are of highest quality and are considered valid and credible within the scientific and clinical community. In order to accomplish this objective, the Contractor shall provide assistance and guidance from experts in clinical trial quality assurance. Specifically, the Contractor shall provide scientific resources to review, monitor, and recommend changes (if needed) to the quality assurance procedures in NIA-funded clinical trials. The overall objective of Safety-Related Operations Support is to ensure that no participant enrolled in the NIA funded clinical trial is exposed to unnecessary or excessive risk while participating in a trial. To assist the investigators in meeting this objective, the Contractor shall provide expert assistance and guidance in safety surveillance and shall provide scientific resources to review, monitor, and recommend changes, if required, to the safety surveillance programs in the NIA-funded clinical trials. Statistical and Methodological Consultation may be required as follows: 1) to evaluate requests to submit applications for large clinical research studies; 2) to help solve methodological problems in ongoing clinical projects; and 3) to perform additional statistical analyses of existing datasets and de-identification of the trial datasets in preparation for data sharing. The NIA anticipates that during the contract period of performance there will be new policies and regulations regarding subject protection, confidentiality and safety, and other clinical trial issues. Training of NIA staff in Clinical Trials Procedures is for interpreting and implementation of new policies and regulations. The Contractor shall assist the NIA program staff in the maintenance of the NIA Human lnterventional Studies database, a tracking system for all interventional study grants and contracts. This readily accessible database provides rapid reporting of all interventional clinical research projects supported by NIA. The Contractor shall plan for an orderly Transition Planning and Contract close out procedures at the end of the contract.

REPORTS/DELIVERABLES

The following reports will be required: (1 )Annual Performance Plan; (2) Monthly Progress Report; (3) Annual Progress Report; (4) Investigator's Tool Box Report; ( 5) Confidentiality Affidavit; (6) Site Visit Report; (7) NIA Safety Training Course Modification Proposal; (8) Safety Monitoring Procedures Review Report; (9) Quarterly Serious Adverse Event (SAE) Summary; (10) Safety Report Review; (11) CTAP/DSMB Meeting Minutes; (12)
Statistical Support Task Report; (13) Consultation Materials.

This proposed acquisition was previously publicized under sources sought notice HHS
-NIH-NIDA(AG)-SBSS-16-019.

All responsible sources may submit a proposal which will be considered by the agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.