Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 24, 2016 FBO #5206
SOLICITATION NOTICE

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

Notice Date

2/22/2016
 

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, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
 

ZIP Code

20852
 

Solicitation Number

N02AT67007-C16
 

Archive Date

5/23/2016
 

Point of Contact

Mary E. Loesch, Phone: 301-624-8764, C. Timothy Crilley, Phone: 301-624-8743
 

E-Mail Address

mary.loesch@nih.gov, tcrilley@mail.nih.gov
(mary.loesch@nih.gov, tcrilley@mail.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

National Institutes of Health (NIH) National Center for Complementary and Integrative Health (NCCIH) intends to re-compete contract HHSN261201100086C with Westat, Inc. Freedom of Information Action (FOIA) requests regarding the current contract with Westat, Inc. should be directed to Suzanne Milliard at milliars@mail.nih.gov. 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 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, United States (U.S.) and, where appropriate, country-specific regulatory requirements and guidelines; (2) Routine site monitoring visits 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; (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 Statement of Work as evidenced by the following: (1) Organizational experience in planning and conducting the breadth of routine and specialized clinical site and study monitoring visits required, including experience in the identification and resolution of site performance problems and deficiencies; (2) Propose Standard Operating Procedures (SOPs) for both routine and specialized clinical site monitoring visits; (3) Propose approach to scheduling clinical site monitoring visits, the cost/resource efficiencies of the proposed approach, and experience in and approaches implemented to resolve scheduling problems and conflicts; (4) Plans and approaches for accommodating urgent and/or unanticipated site monitoring needs; (5) Organizational experience with and proposed plans and procedures for coordinating clinical site monitoring functions; (6) Propose Training Plan for all training activities to be conducted for site monitors on staff as well as newly hired monitors; (7) Propose plan for evaluating training activities, including performance metrics; (8) Organizational experience in planning and conducting training for site monitors; (9) Propose QA/QC Plan for standardizing contract processes, ensuring compliance with domestic and country-specific regulations and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, and assessing Contractor performance and the quality of clinical site monitoring functions performed; (10) Results of independent audits conducted over the past 5 years, problems/deficiencies identified, and correct/remedial actions implemented to resolve identified problems and deficiencies. The Government anticipates that ONE (1) contract will be awarded with a base period of one year and four one year option periods. The North American Industry Classification System (NAICS) code for this project is 541990 with a size standard of $15.0 million. It is anticipated that the Request for Proposal (RFP) will be available electronically on Tuesday, March 8, 2016 and may be accessed through the 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.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02AT67007-C16/listing.html)
 

Place of Performance

Address: 8490 Progress Drive, Suite 400, Riverside Five, Frederick, Maryland, 21701, United States

Zip Code: 21701
 

Record

SN04027371-W 20160224/160222235026-6e424055a17bf4867e7e0f8aaed4ee86 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |