SOLICITATION NOTICE
R -- Clinical Studies Monitoring Service (CSMS) for National Center For Complimentary and Alternative Medicine (NCCAM)
- Notice Date
- 1/11/2011
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions-Treatment and Support Branch, Bldg 244, Room 112, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- N02-AT-17003-64
- Archive Date
- 2/15/2011
- Point of Contact
- Kimberly M. Goetz, Phone: 3012284225, C. Timothy Crilley, Phone: 301/228-4224
- E-Mail Address
-
goetzkm@mail.nih.gov, tcrilley@mail.nih.gov
(goetzkm@mail.nih.gov, tcrilley@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- TITLE: Clinical Studies Monitoring Service (CSMS) for National Center For Complimentary and Alternative Medicine (NCCAM) POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS THAT MAYBE ISSUED. DESCRIPTION: THIS ACQUISITION IS BEING ADVERTISED UNDER FULL AND OPEN COMPETITION. The National Cancer Institute (NCI)/National Center for Complementary and Alternative Medicine (NCCAM), National Institutes of Health (NIH), is seeking a qualified contractor to provide comprehensive clinical site and study monitoring services for the NCCAM extramural clinical studies research portfolio and other support efforts as outlined in the SOW. The Contractor would also perform specialized clinical site visits as needed by NCCAM which may be conducted independently or in conjunction with other clinical monitoring site visits. These services will include, but are not limited to the following: (1) Site initiation visits prior to clinical study implementation to ensure compliance with NCCAM, U.S. and, where appropriate, country-specific regulatory requirements and guidelines. (2) Routine site monitoring visits for active select phase 0, phase 1, and phase 2 clinical studies to ensure compliance with NCCAM, 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. (10) Other technical and administrative support to coordinate meetings, teleconferences, review and/or preparation of study-related documents and material. This solicitation is anticipated to result in one (1) award to an offeror capable of performing all aspects of the Statement of Work. The anticipated contract award shall be a cost-reimbursement, term type cost reimbursement. The contract will be awarded for a twelve (12) month base period, plus four (4) one-year options, for a total five-year period of performance, if all options are exercised. All responsible and qualified sources may submit a proposal which shall be considered by the Government. This advertisement does not commit the Government to award a contract. The North American Industry Classification System (NAICS) code for this project is 541990 with a size standard of 7.0 Million dollars. The solicitation is scheduled for electronic release on or about January 27, 2011 and receipt for proposals will be due on or about 2:00 p.m., Eastern Prevailing Time on February 28, 2011. The RFP may be accessed through the NCI Office of Acquisitions homepage by using the following internet address - http://rcb.cancer.gov/rcb-internet/index.jsp; once at the site, click on Current Requests for Proposals to access. Interested parties are expected to review this notice and the Request for Proposal to familiarize themselves with the requirements of the project; failure to do so will be at your firm's own risk. All information required for submission of a proposal will be contained in the electronic RFP package. This is a recompetition of Contract Number N01AT59901, awarded to KAI Research, Inc. Freedom of Information Act (FOIA) requests regarding the current contract with KAI Research, Inc. should be directed to Suzy Milliard at milliars@mail.nih.gov. Only electronic copies of the solicitation are available. It is the offeror's responsibility to monitor the above internet site for the release of this solicitation and any amendments. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. No collect calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF2/N02-AT-17003-64/listing.html)
- Record
- SN02357945-W 20110113/110111234108-7a5fa8ff1a5359fb060bc5685df23757 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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