Inactive

AMENDMENT 02 is posted Please view the Attachments for details.

Inactive

SMALL BUSINESS SOURCES SOUGHT NOTICE Agency: The National Institutes of Health, National Institute of Mental Health (NIMH) Title: Clinical Research and Study Monitoring Support for NIMH Studies NOTE: ... SMALL BUSINESS SOURCES SOUGHT NOTICE Agency: The National Institutes of Health, National Institute of Mental Health (NIMH) Title: Clinical Research and Study Monitoring Support for NIMH Studies NOTE: This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time. 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. Statement of Need and Purpose: To acquire comprehensive clinical site and study monitoring services for studies funded by the National institute of Mental Health (NIMH). Background: The NIMH Office of Clinical Research (OCR) provides institute-wide coordination and oversight for NIMH-funded clinical research studies including strategic guidance and recommendations to NIMH leadership about clinical research initiatives. An important component of the oversight activities involve on-site monitoring of NIMH funded clinical research. Project Requirements: I. Development of Clinical Site Monitoring Standard Operating Procedures for Implementation The Contractor shall develop Standard Operating Procedures (SOPs) governing all aspects of the conduct of specialized (e.g., for cause) clinical site monitoring visits to the COR within fourteen (14) calendar days of the contract effective date. The SOP will be reviewed by the COR and the NIMH OCR and additional changes may be recommended prior to implementation. The SOP shall include the following components: A description of each aspect of clinical research conduct and clinical site operations to be reviewed Sources of data and other information for monitoring each aspect of clinical research conduct and clinical site operations. The contractor shall work in collaboration with NIMH to determine this information. The types of clinical site personnel and key study personnel required to participate in site visits. Personnel will include study staff within NIMH funded studies. Staff may be federal employees or non-federal personnel. Detailed operational instructions addressing the site visit process. Scheduling processes and procedures for preparing clinical site staff for monitoring visits. These processes and procedures shall include questions and other materials to be provided to site staff in advance of site visits, as well as data, documents, and other information to be gathered and made available by clinical sites. The average length of the site visit and the number of contract monitors required. The contractor shall provide data to support the length of site visits based on the study design and sources of data to be reviewed. (The length of a site visit and the number of contract monitors required will be decided in collaboration with the NIMH OCR and COR.) Additionally, the Contractor shall keep abreast of all changes in Federal requirements governing human subjects’ research, GCP and ICH guidelines, and NIMH policies and procedures. The Contractor shall update SOPs, as necessary, within thirty (30) calendar days of the effective date of all such changes; and submit updated SOPs for COR and the NIMH OCR for review and approval. Updated SOPs shall be implemented by the Contractor only after receipt of written COR approval. II. Specialized Clinical Site Monitoring Visits Specialized Site Visits to NIMH-funded grants clinical sites monitor and ensure compliance with: (1) 21 CFR 312—GCP; (2) 45 CFR 46—“Human Subjects Protection;” (3) the ICH E6-GCP Guidelines; (4) protocol-specific requirements; (5) policies and guidance set forth by the U.S. Department of Health and Human Services Office of Human Research Protections and (6) NIMH policies and procedures. Each site visit will be tailored to the study protocol/procedures, and will include (but not be limited to): a review of the study regulatory binder, informed consent forms, subject eligibility, safety reporting, ensuring subjects were correctly randomized, protocol violations/deviations, primary outcome data, and electronic case report forms. The visit will also include an assessment of site operations, IP accountability (if applicable), and other items as directed by the NIMH OCR. A. Clinical Site Monitoring Personnel The Contractor shall provide clinical and technical personnel with appropriate training, expertise and experience to carry out the site monitoring functions of the this requirement. The Contractor shall provide and maintain a cadre of site monitors with the training, experience, and capabilities to perform clinical site and study monitoring functions for NIMH supported clinical trials and clinical sites. Site monitors shall not be considered key personnel but are expected to have certain skills and abilities. Specifically, site monitors are expected to have: Training and at least 5 years of experience in monitoring clinical trials and studies for mental health and psychiatric disorders Training and significant experience in monitoring clinical trials and studies conducted in the United States and Canada sites Current knowledge of FDA regulations, Good Clinical Practice (GCP), and human subjects regulations. B. Specialized Clinical Site Monitoring Visits The Contractor shall perform specialized clinical site monitoring visits to be assigned by the NIMH OCR. Specialized clinical site monitoring visits may include remedial and for-cause visits. Scheduling of “for cause” site visits will be determined by the NIMH OCR on a case-by-case basis depending on the nature and potential risk characteristics associated with such visits. These visits will focus on specific aspects of clinical trial conduct and clinical site operations. The Contractor will collaborate with the NIMH OCR in determining which specialized forms and templates will be used (and/or developed) that specify the data and other information to be collected, assessed, and reported for specialized clinical site visits. The COR, in collaboration with the NIMH OCR, will oversee this process and will approve all forms and templates prior to implementation. During specialized clinical site monitoring visits the Contractor shall review and document the following aspects of clinical research conduct and clinical site operations: The accuracy and completeness of reportable data on Case Report Forms (CRFs). Adherence to inclusion and exclusion criteria. Reporting of protocol violations. Accuracy and completeness of the reporting of protocol exemptions. Documentation and reporting of Serious Adverse Events (SAEs). Documentation of informed consent and adherence to informed consent procedures. Documentation of findings, including verification of endpoints. Maintenance of appropriate source documentation. Adherence to federal, GCP and ICH guidelines, and NIMH policies and procedures. Adequacy of operations, performance, and management related to protocol-specific requirements. Regulatory review to assess the adequacy of procedures for ensuring compliance with regulatory requirements. Adherence to other protocol specific requirements For all specialized clinical site monitoring visits, the contractor will provide clinical sites involved with a description of the site-specific activities/protocols to be reviewed, data and other information to be collected/assessed, and instructions on the clinical site personnel and materials to be made available. This information shall be provided to the clinical sites no less than fourteen (14) calendar days prior to the scheduled site visit. Reports of clinical site monitoring visits shall be prepared using site visit report templates determined (and/or developed) in collaboration with the NIMH OCR and approved by the COR and NIMH OCR. The reports must detail any adverse findings or compliance violations as well as corrective recommendations. Reports shall be delivered to the COR, the NIMH OCR and other appropriate NIMH staff members, no later than ten (10) business days following completion of each site visit. Findings of suspicious data, possibility of intentional misrepresentation of data, and/or disregard for regulatory safeguards and critical findings (e.g., any fraudulent findings, prefilling of CRFs, invalid signatures, and unreported Serious Adverse Events) shall be reported to the COR, the NIMH OCR and other appropriate NIMH staff members within 24 hours of site visit completion by telephone and email. III. Facilities, Equipment, and Other Resource Requirements The Contractor shall provide all facilities, equipment, and other resources necessary to carry out the requirements detailed in this Statement of Work. This includes the following: Equipment, or other resources to conduct clinical site and study monitoring activities, and to provide ready access to monitoring staff and services for clinical sites in the United States and Canada. Information technology systems and state-of-the-art field equipment, including laptops, blackberries, and smartphones for the conduct of specialized clinical site visits and monitoring activities conducted at clinical sites in the United States and Canada. The Contractor shall ensure that all personnel working under this requirement are appropriately trained with the skills and abilities relevant to this requirement. Toward this end, the Contractor shall provide a Training Plan for site monitors and other contractor personnel for Government review and approval. A draft training plan shall be submitted with the Contractor’s proposal for inclusion in technical evaluation. IV. Personnel Training and Oversight Please note that HHS policy requires Contractors and Subcontractors to receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements. The Contractor will be responsible for assuring that each Contractor/Subcontractor employee has completed the NIH Computer Security Awareness Training prior to performing any contract work, and thereafter completing the NIH-specified fiscal year refresher course during the period of performance of the contract. The successful offeror shall maintain a listing of all individuals who have completed this training and shall submit this listing to the COR each year. Additionally, Contractor employees and subcontractors shall be required to receive ethics training. The Contractor will be responsible for assuring that each Contractor/Subcontractor has completed the Non-Employee Ethics Orientation: Interacting with Government Employees provided by the United States Office of Government Ethics prior to performing any contract work. The successful offeror shall maintain a listing of all individuals who have completed this training and shall submit this listing to the COR. V. Contract Management The Contractor shall provide sufficient project management support to ensure adequate management and coordination of all site monitoring activities. This effort shall include responsibility for technical and administrative support (including travel arrangements when approved by the COR), financial management, reporting and deliverables, and proper invoicing. The Contractor shall ensure that all contractor personnel safeguard intellectual property, the confidentiality of human subjects and other data, and other information provided by third parties or by the Government, as well as data generated through this contract. Contract management shall also oversee quality assurance and control. Anticipated Period of Performance/Contract Mechanism: One 12-months base period with four (4) 12-months option periods. Special Instructions: If you or your firm/business has an interest and possess the required expertise we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurement will be classified under North American Industrial Classification (NAICS) code 541990, size standard is $16.5M. All respondents are requested to identify their firm's size and type of business. Interested firms responding to this Small Business Sources Sought Notice should adhere to the following: Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities and at a minimum address the below: respondents’ opinions about the difficulty and/or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; information regarding respondents’: (a) 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 similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information respondents’ DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code; any other information that may be helpful in developing or finalizing the requirement. The capability statement should not exceed 15 pages using a font size 10 or larger and shall include: respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and the name, address, telephone number, and e-mail address of the Contract Specialist or Contracting Officer to whom the information should be sent. 3. All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Kristina.Jenkins@nih.gov in MS Word or Adobe Portable Document Format (PDF). by the closing date and time of this announcement. Facsimile responses will not be accepted, and all responses must reference the Notice ID. “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. 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(s).”