Clinical Studies Monitoring Service (CSMS) for the National Center for Complementary and Integrative Health (NCCIH)

Note: This synopsis follows a Sources Sought notice that was released on October 5, 2020 under HHSNIHNCISBSSTSB10922Cl6. THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. IT IS ANTICIPATED THAT A SOLICITATION WILL BE ISSUED ON A LATER DATE. Contracting Office Address Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, 8490 Progress Drive, Suite 400, Frederick, MD 21701-4998 National Institutes of Health (NIH) National Center for Complementary and Integrative Health (NCCIH) intends to re-compete contract HHSN261201600011C awarded to Westat, Inc. The purpose of the contract will be to continue follow-up of comprehensive clinical site and study monitoring services for the NCCIH extramural clinical studies research portfolio and other support efforts as outlined in the attached, draft Statement of Work. The Contractor would perform specialized clinical site visits as needed by NCCIH which may be conducted independently or in conjunction with other clinical monitoring site visits. Major objectives include: 1) Site initiation visits prior to clinical study implementation to ensure compliance with NCCIH, U.S. and, where appropriate, country-specific regulatory requirements and guidelines; 2) Routine site monitoring visits (on-site or remote) for active select clinical studies to ensure compliance with NCCIH, U.S. and, where appropriate, country specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical study data, and assess adherence to protocol-specific requirements; 3) Specialized site monitoring visits for a variety of purposes, including regulatory audits, assessments of overall and protocol-specific research pharmacy operations and management of investigational products, and remedial or for cause site visits to implement and ensure adherence to corrective actions required to address site or study deficiencies identified through routine site monitoring; 4) Site closeout visits to ensure appropriate completion of clinical studies, storage of clinical records and disposition of investigational products; 5) Preparation of written reports of all site monitoring visits, including identification of problems and deficiencies and recommendations for remedial actions; 6) The development and implementation of Standard Operating Procedures for the conduct of clinical site and study monitoring functions, including the components to be reviewed/assessed and the processes to be used for each type of site visit; 7) The development and implementation of a training plan for site monitors on staff and new hires and for evaluating the effectiveness and efficiency of training activities conducted; 8) The development and implementation of a Quality Assurance/Quality Control (QA/QC) Plan to ensure the efficient and effective performance of monitoring functions and the appropriate management of the project; 9) The development and implementation of an Integrated Master Project Plan to provide for the overall management, integration and coordination of all contract activities; and 10) Other technical and administrative support to coordinate meetings, teleconferences, review and/or preparation of study-related documents and materials. Prospective offerors must be able to adequately demonstrate the appropriateness, adequacy, soundness and feasibility of proposed plans and procedures and capabilities for carrying out the functions specified in the attached, draft Statement of Work. The evaluation factors will be outlined in any resultant solicitation, including but not limited to, technical evaluation of the proposed: 1) Technical Plan/Approach including Clinical Site Monitoring and Reporting, Training, and Quality Assurance/Quality Control, 2) Project Management, including Project Management Personnel, the Integrated Master Project Plan, and Subcontract Management and Reporting, and 3) Clinical and Technical Personnel & Related Factors. In additional to technical factors, the proposals will be evaluated on additional factors such as cost/price, past performance, and other factors outlined in the solicitation. Technical factors are anticipated to receive paramount consideration, and all evaluation factors other than cost/price, when combined, are anticipated to be significantly more important than cost/price. The Government intends to make awards to the Offeror whose proposal provides the overall best value to the Government. The Government anticipates that ONE (1) contract will be awarded with a base period of one year and four one-year option periods. It is anticipated that the contract type will be cost-plus-fixed fee and that the contract will begin on or about July or August 2021. The North American Industry Classification System (NAICS) code for this project is 541990 with a size standard of $16.5 million. It is anticipated that the Request for Proposal (RFP) will be available electronically on or about Monday, January 11, 2021 and may be accessed through the Contract Opportunities site on Beta.SAM.gov (formerly FedBizOpps at www.fbo.gov). The RFP will be advertised as full and open competition. WE ENCOURAGE ALL RESPONSIBLE SOURCES TO 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 or email transmissions will be accepted. IT IS THE OFFEROR'S RESPONSIBILITY TO MONITOR THE ABOVE-MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.