SOURCES SOUGHT
A -- NIAID CLINICAL SITE MONITORING
- Notice Date
- 10/16/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAID(AI)-SBSS-15-045
- Archive Date
- 11/14/2015
- Point of Contact
- Patrick Finn, Phone: 240-669-5401, John R. Manouelian, Phone: 240-669-5152
- E-Mail Address
-
patrick.finn@nih.gov, manouelj@niaid.nih.gov
(patrick.finn@nih.gov, manouelj@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), 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. The National Institute of Allergy and Infectious Diseases, Division of Acquired Immunodeficiency Syndrome (DAIDS) supports the advancement of therapies for HIV infection and its complications, and supports the development of HIV/AIDS vaccines and other prevention measures. Through grants and contracts, DAIDS sponsors Phase I, II, III and IV clinical trials to evaluate the safety and efficacy of therapeutics, vaccines and other preventive modalities. DAIDS has designed, developed and sponsored extramural Clinical Trial Networks, supported investigator-initiated clinical trials, and partnered with other Government and private organizations, in order to accomplish the Division's scientific objectives. Currently, NIAID/DAIDS supports more than 150 clinical trials in over 17 countries, at more than 110 domestic and international clinical sites. 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). Over the past six years, approximately 90 monitors have performed more than 8,000 monitoring trips to over 200 clinical sites, in over 20 countries. Purpose and Objectives The purpose of the proposed contract will be to continue to provide 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. The current NIAID/DAIDS Clinical Site Monitoring contract was awarded to Pharmaceutical Product Development, LLC, Wilmington, NC, on February 1, 2010, for a total period of seven years. The Government anticipates a potential need to increase the level of effort, for the following reasons, which are also within the scope of the contract: (1) increased level of effort, in order to support unanticipated needs; and (2) increase level of effort, in order to support the Provision of Site Performance Risk-Based Monitoring tool. Increases in effort for these services would be implemented through the exercise of contract options, at the discretion of the Government. Project requirements 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 It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contract will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about December 1, 2016. The requirement will be for the delivery of sixty-two (62) full time equivalents (FTEs) per year for the Base Period (Year 1) and sixty-two (62) FTEs per year for Options 1-6 (Years 2-7). In addition, the Government may exercise options for an increased level of effort to support the following: (1) unanticipated increases in demand for the activities supported by the base requirements of this contract; and (2) the development or adaptation (including the maintenance of) a commercially available system, in order to implement site performance risk-based monitoring. These Options are defined as follows: Options 7-8, 10-11, 13-14, 16-17, 19-20, 22-23 and 25-26 - Increased Level of Effort for Unanticipated Increases in Demand: During the course of the contract, it may be necessary to increase the level of effort, in order to support unanticipated increases in demand for the activities supported by the base requirements of the contract. Such an increase would require an increase in the Contractor's activities, to be activated, at the discretion of the Government, as an Option. If the Government elects to exercise this Option, the Contractor shall provide an additional five (5) FTEs per option. Up to two options of this type may be exercised in any one year. The period of performance of an Option for Increased Services will not exceed the term of the Base year or Option year in which the Option is exercised. Options 9, 12, 15, 18, 21, 24 and 27 - Increased Level of Effort for Unanticipated Increases in Demand: During the course of the contract, it may be necessary to increase the level of effort, in order to support unanticipated increases in demand for the activities supported by the base requirements of the contract. Such an increase would require an increase in the Contractor's activities, to be activated, at the discretion of the Government, as an Option. If the Government elects to exercise this Option, the Contractor shall provide an additional ten (10) FTEs per option. One option of this type may be exercised in any one year. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised. Options 28 and 29, and 30-34 - Increased Level of Effort for the Provision of a Site Performance Risk-Based Monitoring tool: During the course of the contract, it may be necessary to increase the level of effort in order to support the provision of a site performance risk-based monitoring tool. Such an increase would require an increase in the Contractor's activities, to be activated, at the discretion of the Government, as an Option. The system should provide the ability to identify and weigh key risk factors that may have the greatest impact on participant safety and data integrity, ability to define threshold levels for risk factors and "flag" sites (i.e. green-yellow-red system) that fall outside of pre-determined levels for high, medium and low risk. In addition, the system should provide "real-time" reports, to allow for the identification of site quality and compliance risks, so that objective decisions can be made regarding frequency, degree, and type of monitoring visits (i.e., remote or on-site) for clinical research sites. The system should be flexible enough to accommodate any changes in business processes, and provide a variety of reports. Once developed and ready for production, the application will be hosted in the NIAID Office of Cyber Infrastructure and Computational Biology (OCICB) computing environment. The Contractor will communicate and collaborate with the OCICB, in order to determine the requirements for data transfer, to ensure compatibility with the OCICB computing environment. Development Phase (Options 28-29): During contract years 2 and/or 3, the government may exercise options (Option 28 and/or 29), in order to support the development or adaptation of a commercially available system, in the N-CRMS or as a stand-alone system, in order to implement site performance risk-based monitoring (it is anticipated that the "development phase" should last approximately 1-2 years). Should the Government elect to exercise Option 28 and/or 29 (Development), the Contractor shall provide resources for the increase in work volume by two (2) FTEs for each option. The period of performance of an Option for Increased Services will not exceed the term of the Option year in which the Option is exercised. Maintenance Phase (Options 30-34): Beginning in contract year 3 or 4 (depending on when the development phase is complete) and through contract year 7, the system would be in a "maintenance phase", and the government may exercise options (Options 30-34) to support this maintenance. Should the Government elect to exercise Options 30-34 (Maintenance), the Contractor shall provide resources for the increase in work volume by one (1) FTE for each option. The period of performance of an Option for Increased Services will not exceed the term of the Option year in which the Option is exercised. 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., 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/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the activities set forth in the Statement of Work (SOW). Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract, including that performed by any subcontractors and consultants. The Contractor shall ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement, not to exceed five (5) pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Patrick Finn, Contract Specialist, at patrick.finn@nih.gov. The capability statements should be submitted Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word or Corel WordPerfect will also be accepted. The e-mail subject line must specify HHS-NIH-NIAID-SBSS-15-045. 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 October 30, 2015. 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: Contract Specialist: 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.
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