NIAID Clinical Site Monitoring

Introduction This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources, including small and small disadvantaged businesses, to perform a potential R&D requirement. Background This Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has an existing contract (Contract No. HHSN272201700004C) for "NIAID Clinical Site Monitoring," with PPD Development, LP, 929 North Front Street, Wilmington, NC. This contract was awarded on a competitive basis, for a seven-year period, from February 1, 2017 through January 31, 2024, with the purpose of providing comprehensive clinical site and study monitoring services for the NIAID/DAIDS clinical trial research portfolio, including the delivery of monitoring services for unanticipated DAIDS clinical research projects that may be required in response to emerging needs or public health emergencies. A term type/level of effort contract was awarded for the delivery of 62 Full Time Equivalents (FTEs) per year. The total value of the contract is $127,236,253, and the contract includes options for extension of the term (term options) for a total performance period of 7 years, and quantity options for increases in the level of effort. The mission of the DAIDS, NIAID, is to increase the knowledge of the pathogenesis and transmission of HIV, to support the advancement of therapies for HIV infection and its complications, and to support the development of HIV/AIDS vaccines and other prevention measures. NIAID/DAIDS supports extramural Clinical Trials Networks, investigator-initiated clinical trials, and partners with other Government and private organizations, in order to accomplish the Division's scientific objectives. Through grants and contracts, NIAID/DAIDS sponsors Phase I, II, III and IV clinical trials, to evaluate the safety and efficacy of therapeutics, vaccines, and other preventive modalities. The contract was awarded based on the assumptions available at that time that the Contractor would be providing monitoring services for 150 clinical trials in over 17 countries at over 110 domestic and international clinical research sites. At this time, however, the requirement for monitoring services has increased and we are performing monitoring visits to 300 domestic and international sites that are conducting 158 clinical trial protocols. There are also 25 clinical trials, which will require monitoring that are pending implementation. The number of clinical trials in the pipeline for implementation fluctuates as protocol teams develop new studies. This increase in the amount of monitoring services has resulted in the need to increase the number of FTEs that will be needed to carry out work under the contract over the next 5 years. As the Investigational New Drug (IND) Application sponsor for a large number of NIAID/DAIDS-funded clinical trials, NIAID/DAIDS is required to monitor clinical trials, in order to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312 and Human Subjects Protection Title 45 CFR Part 46. Clinical trials are also monitored in accordance with the E6 International Conference on Harmonisation Good Clinical Practices (ICH/GCP). This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NIAID. Purpose and Objectives The purpose of this Research and Development (R&D) Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this R&D Sources Sought Notice, the NIAID may issue a Request for Proposals (RFP) if it deemed necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID's use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement. The objective of this acquisition is to increase the quantity of FTEs to be delivered to the Government through the remainder of the current contract beginning with the next term option (Option 2), beginning February 1, 2019 through January 31, 2020, thereby increasing the effort available to support the monitoring for the increase in the number of clinical research sites, domestic and international, and the number of pending and on-going trials that has increased. Project requirements The NIAID intends to modify the existing PPD Development, LP contract to provide an increase to the required Level of Effort by 20 FTEs for Options 2-6 (Years 3-7) of the current contract. Specifically, the Contractor will be responsible for the following: 1. Conduct site initiation visits prior to clinical trial implementation to ensure compliance with DAIDS, U.S., and, where appropriate, country-specific regulatory requirements and guidelines. 2. Conduct routine site monitoring visits for active clinical trials to ensure compliance with DAIDS, U.S. and where appropriate, country-specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical trial data, and assess adherence to protocol-specific requirements. 3. Conduct 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. Conduct site closeout visits to ensure appropriate completion of clinical trials, storage of clinical records and disposition of investigational products. 5. Prepare written reports on all site monitoring visits, including identification of problems and deficiencies and recommendations for remedial/corrective actions. 6. Develop and implement Standard Operating Procedures for the conduct of clinical site monitoring functions, including the components to be reviewed/assessed and the processes to be used for each type of site visit. 7. Communicate and coordinate clinical site and study monitoring activities and data generated through these activities with other DAIDS clinical research support contractors and HIV/AIDS Clinical Trials Network components. 8. Develop and implement 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. Ability to remotely interact with various NIAID systems such as the NIAID-Clinical Research Management System (N-CRMS). Anticipated period of performance The increase in FTEs is anticipated to be applied to the term options (Options 2-6), for the period February 1, 2019 through January 31, 2024, of the current contract. Other important considerations Work under this contract will be performed in the U.S. and internationally, in approximately 20 countries. Capability statement / information sought Capability statements submitted as a result of this announcement should demonstrate the offeror's qualification, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability statements should clearly convey information regarding the respondent's capabilities, including: (1) staff expertise, including their availability, experience and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested Contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort, which includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator/co-PI, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: a. DUNS number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought f. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., large business, non-profit, educational institute, small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/ Responses must be submitted no later than 3:00 PM (Local Time), May 30, 2018. Capability statements will not be returned and will not be accepted after the due date. These statements should be submitted electronically (via e-mail) to Patrick Finn, Contracting Officer, at patrick.finn@nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify HHS-NIH-NIAID-RDSS-18- NIHAI2018014. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted, tailored capability statements are due not later than 3:00 PM (E.S.T.), on May 30, 2018. CAPABILITY STATEMENTS WILL NOT BE RETURNED AND WILL NOT BE ACCEPTED AFTER THE DUE DATE. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contracting Officer: Patrick Finn Email Address: patrick.finn@nih.gov Contracting Officer: John Manouelian Email Address: manouelj@mail.nih.gov Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.