SOURCES SOUGHT
L -- Clinical Site and Study Monitoring Services for the Collaborative Hubs for International Research on Mental Health (CHIRMH)
- Notice Date
- 2/28/2014
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NIDA(SSSA)-2014-097
- Archive Date
- 3/29/2014
- Point of Contact
- Jeffrey A Williams, Phone: (301) 402-1677
- E-Mail Address
-
jeffrey.williams@nih.gov
(jeffrey.williams@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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) the classification or type of small business (e.g., whether they are small businesses; HubZone small businesses; service-disabled veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; women-owned small business (WOSB); economically disadvantaged women-owned small business (EDWOSB); 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. Teaming and partnering arrangements among small businesses are encouraged. (1) PURPOSE The purpose of this requirement is for clinical site and study monitoring services for the Clinical Site and Study Monitoring Services for International Research on Mental Health (CHIRMH). CHIRMH is a set of cooperative agreements funded by the National institute of Mental Health (NIMH) and designed to increase the research base on scaling up the delivery of evidence-based mental health care in low- and middle-income countries. (2) BACKGROUND INFORMATION The National Institute of Mental Health (NIMH), one of the 27 institutes and centers that constitute the National Institutes of Health (NIH), is the lead federal agency for research on mental illness. The mission of the NIMH is to transform the understanding and treatment of mental illness through basic and clinical research, paving the way for prevention, recovery, and cure. To fulfill its mission, the Institute conducts research on mental disorders and the underlying basic science of brain and behavior; supports research on these topics throughout the United States and the world; disseminates information on mental illnesses; supports training for scientists to conduct mental health research; and communicates with scientists, patients, the news media, and health professionals about mental illness, the brain, behavior, and research advances in these areas. The NIMH Office for Research on Disparities and Global Mental Health (ORDGMH) coordinates the Institute's efforts to reduce mental health disparities within and beyond the United States. As part of the NIMH's Global Mental Health Research Strategy, ORDGMH sponsors research that addresses disparities in access to mental health care. The proportion of people who need, but do not receive care-the mental health treatment gap-is exacerbated by a dearth of health care workers available to provide evidence-based mental health services. A growing science base for reducing this treatment gap exists for higher income countries, but far less research has been conducted in low- and middle-income countries (LMIC), where approximately 85% of the world's population resides. LMICs face special challenges in providing health care in general and mental health care in particular, due in large part to shortages of skilled healthcare providers. Although human resource inadequacies for mental health worldwide are well known, policy-makers and international agencies have called for scale-up of mental health services. Task shifting-that is, delegating specific tasks from specialists to varied cadres of health professionals with abbreviated training-has shown promise with certain mental health interventions. Studies suggest that delivery of mental health services in primary healthcare settings through community-based and task-shifting approaches, in combination with appropriate training and enhanced capacity, can help to reduce burden on caregivers and improve the coordination of care for individuals with mental disorders.2 ORDGMH has established the Collaborative Hubs for International Research on Mental Health (CHIRMH) to increase the research base on scaling up the delivery of evidence-based mental health care in LMICs. Four regional hubs constitute the CHIRMH; each hub involves a multidisciplinary research group of investigators and their collaborators spanning multiple countries. The four hubs operate in Africa, Latin America, and Asia. They conduct innovative mental health research, build research infrastructure, and develop local/regional research capacity. As part of their research agenda, each hub is conducting a clinical trial on task-shifting/task-sharing for the delivery of mental health services. The purpose of this requirement is to provide clinical site and study monitoring services for the CHIRMH clinical trials. The CHIRMH clinical trials for which monitoring services shall be provided are listed below. Some minor aspects of the trials may change. (A) Regional Network for Mental Health Research in Latin America (RedeAmericas): ReDeAmericas is a collaborative effort of investigators and stakeholders from urban centers in Argentina (Buenos Aires, Cordoba, Neuquen), Brazil (Rio de Janeiro), Chile (Santiago), Colombia (Medellin), and in the United States (New York City). Their objective is to improve the condition of people with severe mental disorders in urban Latin America. 1. Research Agenda (one protocol adapted to two sites): To conduct a randomized controlled trial of an integrated system of primary care and secondary mental health services referred to as Community Health Care for individuals with Severe Mental Disorders (CHC-SMD). 2. Hub Leadership: Columbia University in New York, New York. 3. Study Sites: Data will be collected at community-based health care clinics in Rio de Janeiro, Brazil, and Santiago, Chile. 4. Hub Website: http://www.redeamericas.org/ (B) AFrica Focus on Intervention Research for Mental health (AFFIRM): AFFIRM involves collaboration among researchers and stakeholders in South Africa, Ethiopia, Ghana, Malawi, Uganda, and Zimbabwe. AFFIRM aims to improve the delivery of cost-effective interventions for mental health disorders in Sub-Saharan Africa. 1. Research Agenda (two protocols): To conduct two randomized controlled trials of a low cost task sharing intervention - for maternal depression in South Africa, and for severe mental disorders in Ethiopia. 2. Hub Leadership: University of Cape Town in Cape Town, South Africa. 3. Study Sites: Data will be collected at healthcare clinics in Cape Town/Khayelitsha, South Africa and in Addis Ababa/Butajira, Ethiopia. 4. Hub Website: http://www.affirm.uct.ac.za/ (C) South Asian Hub for Advocacy, Research and Education on Mental Health (SHARE): SHARE involves collaboration among researchers and stakeholders in India, Pakistan, Afghanistan, Bangladesh, and Nepal. SHARE aims to contribute to the reduction of the mental health treatment gap in South Asia through a program of research on task-shifting and intervention for maternal depression. 1. Research Agenda (one protocol adapted to two sites): To conduct a randomized controlled trial of a task sharing intervention in which trained and supervised community health workers assist in delivering care for maternal depression. 2. Hub Leadership: London School of Hygiene and Tropical Medicine 3. Study Sites: Data will be collected in village clusters in Rawalpindi, Pakistan, and in hospitals in Goa, India. 4. Hub Website: http://www.sharementalhealth.org/ (D) Partnerships for Mental Health Development in Sub-Saharan Africa (PaM-D): PaM-D involves collaboration among researchers and stakeholders in Nigeria, Ghana, Kenya, and South Africa. The project aims to expand services for persons suffering from psychosis in Sub-Saharan Africa. 1. Research Agenda (one protocol): To conduct a randomized controlled trial of a collaborative shared care package designed to improve the evaluation of mental health problems by traditional health providers, reduce the use of harmful intervention approaches, and facilitate appropriate treatment, consultations, and referrals for individuals with psychosis 2. Hub Leadership: Ibadan University, Ibadan, Nigeria 3. Study Sites: Data will be collected in and around Ibadan, Nigeria, and Accra, Ghana. 4. Hub Website: http://www.pam-d.org/ (3) PROJECT REQUIREMENTS (A) Scope of Clinical Site and Study Monitoring Functions: Offeror(s) shall provide comprehensive clinical site and study monitoring services for the NIMH/ORDGMH CHIRMH clinical trials. The scope of activities to be performed may include: 1. Site initiation visits prior to clinical trial implementation to ensure compliance with ORDGMH, NIMH, U.S. and, where appropriate, country-specific regulatory requirements and guidelines. 2. Routine site monitoring visits for active clinical trials to ensure compliance with ORDGMH, NIMH, 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. Specialized site monitoring visits for a variety of purposes, including regulatory audits, assessments of overall and protocol-specific research operations, investigation of issues related to human subjects protections, and remedial or "for cause" 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 trials, storage of clinical records and data, and disposition of study materials. 5. Preparation of written reports detailing the outcomes of all site monitoring visits, including identification of problems and deficiencies and recommendations for remedial actions. 6. 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. Provision of efficient on-going training and oversight for site monitors on staff and new hires, and for monitoring the effectiveness of training and oversight activities. 8. Other technical and administrative support through meetings, teleconferences, and review of study-related documents and materials. 9. Conduct of quality control measures to ensure efficient and effective performance of monitoring functions and project management. (B) Clinical Site Monitoring Visits: Offeror(s) shall conduct both routine and specialized monitoring visits to NIMH ORDGMH sponsored CHIRMH clinical sites to ensure compliance with : (1) 21 CFR 312-GCP; (2) 45 CFR 46-"Human Subjects Protection;" (3) the ICH E6-GCP Guidelines; (4) country-specific requirements governing human subjects research; (5) protocol-specific requirements; (6) policies and guidance set forth by the U.S. Department of Health and Human Services Office of Human Research Protections and (7) NIMH policies and procedures. (C) Standard Operating Procedures: Offeror(s) shall provide Standard Operating Procedures (SOPs) governing all aspects of the conduct of both routine and specialized clinical site monitoring visits. 1. Separate SOPs shall be provided for: a. Site initiation visits prior to clinical trial implementation b. Routine site visits to monitor compliance with federal and country-specific regulatory requirements, GCP and ICH guidelines, protocol-specific requirements, and NIMH policies and procedures c. Remedial or for cause visits d. Regulatory reviews e. Site close out visits at the completion of clinical trials 2. Each SOP shall address the following components: a. A description of each aspect of clinical trial conduct and clinical site operations to be reviewed b. Sources of data and other information for monitoring each aspect of clinical trial conduct and clinical site operations c. Detailed work instructions d. The types of clinical site personnel required to participate in site visits e. Scheduling process and procedures for preparing clinical site staff, including questions and other materials to be provided to clinical site staff in advance of site visits, as well as data, documents, and other information to be gathered and made available by clinical sites f. The average length of the site visit and the number of contract monitors required 3. SOP Updates: Offeror(s) shall keep abreast of all changes in Federal and country-specific requirements governing human subjects research, GCP and ICH guidelines, and NIMH policies and procedures; update SOPs, as necessary; and submit updated SOPs review and approval. Updated SOPs shall be implemented by the Offeror(s) only after receipt of written approval. (D) Routine Clinical Site Monitoring Visits and Reports The schedule of routine clinical site monitoring visits will be determined by ORDGMH based on study progress at each site 1. Assignments for routine clinical site monitoring visits shall be provided to the Offeror(s) no less than quarterly and no less than six (6) weeks in advance of each quarter. 2. Routine clinical site monitoring visits shall encompass the following aspects of clinical trial conduct and clinical site operations: a. The accuracy and completeness of reportable data on Case Report Forms (CRFs) b. Adherence to inclusion and exclusion criteria c. Reporting of protocol violations d. Accuracy and completeness of the reporting of protocol exemptions e. Documentation and reporting of Serious Adverse Events (SAEs) f. Documentation of informed consent and adherence to informed consent procedures g. Documentation of findings, including verification of endpoints h. Maintenance of appropriate source documentation i. Adherence to federal and country-specific regulatory requirements, GCP and ICH guidelines, and NIMH policies and procedures j. Adequacy of operations, performance, and management related to protocol-specific requirements k. Regulatory review to assess the adequacy of procedures for ensuring compliance with regulatory requirements l. Adherence to other protocol specific requirements 3. For all routine clinical site visits, the clinical sites involved shall be provided 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. 4. Reports of routine clinical site monitoring visits shall be prepared using site visit report templates provided by the Offeror(s). Reports shall be delivered to appropriate NIMH staff members following completion of each site visit. Findings suspicious and/or suggestive 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 appropriate NIMH staff members within 24 hours of site visit completion by telephone and email. (E) Specialized Clinical Site Visits and Reports Offeror(s) shall perform a variety of specialized clinical site visits, and assigned on an as-needed basis, designed to focus on specific aspects of clinical trial conduct and clinical site operations. Specialized clinical site visits may be conducted either in tandem with other clinical site monitoring visits or as separate independent visits. Offeror(s) shall conduct specialized clinical site visits in accordance with the timelines specified in the monitoring assignments as provided. Scheduling of "for cause" site visits shall be determined by on a case-by-case basis depending on the nature and potential risk characteristics associated with such visits. Offeror(s) shall provide all forms and templates specifying the data and other information to be collected, assessed, and reported for specialized clinical site visits. 1. Specialized clinical site visits to be conducted shall include the following: a. Site Initiation Visits prior to clinical trial implementation to ensure site compliance with all Federal and country-specific regulatory requirements, GCP and ICH guidelines, and NIMH policies and procedures. b. Site Closeout Visits after clinical trial completion to confirm that the proper closeout of clinical trials has been accomplished in accordance with established policies and procedures, including storage of study records and data and disposition of any remaining investigational products and materials. c. Specialized Regulatory Review Visits to assess the appropriateness and adequacy of established procedures for ensuring compliance with Federal and country-specific regulatory requirements, for monitoring adherence on the part of clinical site personnel, and for maintaining a system of records for regulatory documentation. Remedial or "For Cause" Visits to assist clinical site personnel in developing and implementing corrective and remedial actions for identified deficiencies and for other "for cause" reasons, such as scientific misconduct. 2. Specialized Site Visit Plans and Reports a. For all specialized site visits, the clinical sites involved shall be provided 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 twenty-one (21) calendar days prior to the scheduled site visit. b. In most instances, brief summaries of the results of specialized visits shall be prepared and submitted to NIMH staff within five (5) calendar days of visit completion. Critical findings (e.g. any fraudulent findings, prefilling of CRFs, invalid signatures, and unreported SAEs) shall be reported to appropriate NIMH staff member within 24 hours of visit completion by telephone and email. Unless otherwise specified, specialized site visit report templates will be provided by the Offeror(s). Completed reports of specialized site visits shall be sent to NIMH staff member within fourteen (14) calendar days of site visit completion. (F) Technical Personnel Offeror(s) shall provide clinical and technical personnel with appropriate training, expertise and experience to carry out the functions of the contract. This includes the following personnel: 1. Site Monitors - Offeror(s) shall provide and maintain a cadre of site monitors with the training, experience, and capabilities to perform clinical site and study monitoring functions for the full scope of NIMH ORDGMH CHIRMH-supported clinical trials and clinical sites. These monitors must possess: a. Training and experience in monitoring clinical trials, particularly behavioral interventions for mental health and psychiatric disorders b. Training and experience in monitoring clinical trials conducted at domestic sites and at foreign sites in resource-limited countries, preferably LMICs, in a variety of community- and hospital-based settings, and across a broad range of diverse patient populations c. Knowledge of country-specific health care systems, clinical research regulations, local customs and business practices d. Fluency in speaking and reading English and proficiency speaking and reading in the language of countries where clinical trials will be conducted and where clinical records are not maintained in English, including local languages and regional dialects 2. Offeror(s) shall submit, for review and approval, documentation of site monitors' experience, training, expertise, and experience. 3. Recruitment of at least 75% of all site monitors required for active clinical trials and clinical trials planned for imminent implementation must be completed within thirty (30) calendar days of the effective date of the contract; 100% of all site monitors must be hired and trained within sixty (60) calendar days of the contract effective date. 4. In-country site monitors shall be used whenever possible and appropriate to ensure relevant country-specific knowledge and language proficiencies and to reduce costs. 5. Supervisory Site Monitor: Supervisory Site Monitor with responsibility for overseeing the clinical site monitoring activities carried out by the site monitors, including tracking site visit assignments, assigning monitors, developing and maintaining site visit schedules, resolving scheduling conflicts, ensuring completion of appropriate pre-site visit activities and correspondence, and assisting in the assessment of the performance of site monitors and the quality of site monitoring activities carried out. (G) Training 1. Professional Monitors: Offeror(s) shall provide trained professional monitors to perform the work. If the Offeror(s) does not have fully trained and qualified individuals on staff, cannot recruit fully trained and qualified individuals, and needs to train them to carry out the work, the cost of that training shall be at the expense of the Offeror(s), not NIMH. 2. Draft Training Plan: Offeror(s) shall submit for review and approval, a Draft Training Plan delineating all training activities to be conducted for site monitors on staff as well as newly hired site monitors. The draft training plan shall include: a. Plans for initial and continuing training activities to be carried out both in-house and through non-Offeror(s) organizations b. Frequency of training c. Training methods/approaches (e.g., workshops, videocasts, written materials, etc.) d. Provisions for ensuring that experienced monitors accompany new monitors on initial site visits-both routine and specialized e. Plans for monitoring training effectiveness f. Information Security Training. HHS policy requires Offeror(s)s and all subcontractor(s)s to receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements. Offeror(s) shall be responsible for assuring that each of its and its subcontractor (s) employees have 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(s) shall maintain a listing of all individuals who have completed this training and shall submit this listing to the COR each year. g. Ethics Training. Offeror(s) shall be required to receive ethics training. Offeror(s) shall be responsible for assuring that Offeror(s) and any of its subcontractors have 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(s) shall maintain a listing of all individuals who have completed this training and shall submit this listing to the COR. 3. Revised Training Plan: The Draft Training plan shall be revised, as necessary, in accordance with NIMH staff comments, and the Final Training plan shall be submitted and implemented after the receipt of comments. (H) Facilities, Equipment, and Other Resources Offeror(s) shall provide all facilities, equipment, and other resources necessary to carry out the requirements of the contract. This includes the following: 1. Adequate office space to: (a) house senior contract management staff, equipment, and other resources necessary to direct, oversee, and coordinate contract activities, and (b) ensure that Offeror(s) staff are available to meet at the NIMH Offices in Bethesda, Maryland with short notice for urgent situations. 2. Regional or local field offices, equipment, or other resources to conduct clinical site and study monitoring activities within and outside of the U.S. and to provide ready access to monitoring staff and services for domestic and foreign clinical sites. 3. Information technology systems and state-of-the-art field equipment, including laptops, blackberries, and smartphones with international connectivity for the conduct of routine and specialized clinical site visits and monitoring activities conducted at both domestic and foreign clinical sites. (I) Meetings and Teleconferences 1. Contract Initiation Meeting: Within two (2) weeks of the effective date of the contract, Offeror(s) shall participate in a Contract Initiation Meeting to be held at the NIMH Offices in Bethesda, Maryland or by teleconference if the Contractor is not local. The purpose of the Contract Initiation Meeting shall be to orient the Offeror(s) to NIMH contract procedures, discuss NIMH policies and procedures, review the status of site monitors on staff and recruitment efforts to hire monitors within specified timelines, and review current and upcoming clinical site monitoring assignments. 2. Monthly Contract Progress Review Meetings/Teleconferences: Offeror(s) shall plan and conduct contract progress review meetings or teleconferences, at a minimum of monthly intervals, to review: the status of ongoing and future clinical site monitoring assignments; issues related to contract staffing and turnover, workload, and scheduling; significant findings resulting from clinical site monitoring visits conducted over the preceding month and the status of their resolution; project management procedures and assessment of the efficiency and quality of the clinical site monitoring activities conducted. Monthly Contract Progress Review Meetings/Teleconferences shall include NIMH Staff, the Contracting Officer as necessary to discuss contractual matters, the Supervisory Site Monitor, and other relevant Offeror(s) Staff. The meeting/teleconference schedule will be established by the NIMH staff post-award. Offeror(s) shall be responsible for preparing and distributing agendas and other meeting/teleconference materials in advance of the teleconference/meeting, and for preparing and distributing to participants written meeting minutes that include written summaries of all action items and decisions resulting from these meetings/teleconferences. 3. Additional Meetings and Teleconferences: Upon request, Offeror(s) shall arrange teleconferences and/or meetings with NIMH staff to discuss specific clinical site monitoring assignments, including recently completed and upcoming clinical site monitoring visits. For each such meeting/teleconference, Offeror(s) shall be responsible for preparing and distributing the agenda and other materials, including site visit reports and recommendations for improvements or corrective actions in advance of the teleconference/meeting. Offeror(s) shall also prepare and distribute meeting minutes that include written summaries of the major decisions and action items resulting from these meetings and teleconferences and submit to the COR and other COR-designated NIMH staff within meeting/teleconference completion. Annual Progress Review Meetings: Offeror(s) shall plan and conduct annual progress review meetings, at the NIMH offices in Bethesda, Maryland. The purpose of the meetings will be for NIMH Contract staff and NIMH CHIRMH staff to review and discuss: common issues identified across the hubs and recommendations to address them (e.g., common data quality issues, common issues around reporting of Serious Adverse Events, etc.); project progress; problems and obstacles encountered and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, procedures and approaches; contract resources; and future plans. Annual meetings shall be attended by the NIMH staff and the Offeror(s) key personnel, including the Supervisory Site Monitor, financial personnel, and other relevant personnel. In planning and conducting the annual progress review meetings, the Offeror(s) shall be responsible for: a. Developing and submitting the agenda for review and approval before each meeting. b. Developing additional materials and data pertinent to the review of contract progress, performance, efficiency and resource utilization. c. Distributing agendas and additional materials to meeting participants in advance of the meeting dates. d. Developing oral presentation materials. e. Making logistical arrangements for all Offeror(s) participants and paying travel costs for non-government participants. f. Preparing and Submitting Annual Progress Review Meeting Reports, for review and approval. The Annual Progress Review Meeting Reports shall discuss common issues identified across the hubs and provide recommendations to address them (e.g., common data quality issues, common issues around reporting of Serious Adverse Events, etc.); project progress; problems and obstacles encountered and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, procedures and approaches; contract resources; and future plans. (J) Quality Assurance and Control 1. Implement quality assurance and control procedures to: a. Standardize contract processes b. Ensure that the conduct of all contract activities complies with domestic and country-specific regulations governing human subjects research, GCP and ICH guidelines and NIMH/NIH policies and procedures c. Provide for assessment of Offeror(s) performance and quality of clinical site monitoring activities conducted. 2. Provide the quality assurance and control plan to COR within fourteen (14) days of the contract effective date. 3. Provide monthly updates on results of internal quality assurance and control procedures to the COR, including deficiencies and problems identified, actions taken or to be taken to correct deficiencies or resolve problems. Any major problems (e.g., late submission of clinical site monitoring report, inadequate technical knowledge or skills onthe part of a site monitor) shall be reported to the COR within 24 hours of identification and shall include recommendations for resolution. (K) Contract Management 1. Provide for the overall management and coordination of all contract activities. 2. Ensure that all Offeror(s) staff 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. 3. Provide administrative personnel with responsibility for making all travel arrangements and for financial management and financial reporting on all activities conducted by the Offeror(s). It is mandatory that all qualified Offeror(s) have: 1. Regional or local field offices, equipment, or other resources to conduct clinical site and study monitoring activities within and outside of the U.S. and to provide ready access to monitoring staff and services for domestic and foreign clinical sites. Site monitors must have knowledge of country-specific health care systems, clinical research regulations, local customs and business practices, fluency in English and proficiency in the language of countries where clinical trials will be conducted and where clinical records are not maintained in English, including local languages and regional dialects. 2. Information Technology (IT) Security that is compliant with the Federal Information Security Management Act of 2002 (FISMA) to ensure security of all data generated over the life of the contract. See: Federal Information Security Management Act (FISMA; P.L. 107-347, Title III) D. Anticipated Period of Performance October 1, 2014 - September 30, 2018 E. Capability Statement Information Sought Capability statements shall clearly describe your organization's ability, experience, and resources to design and carry out the services listed above and shall include: 1. Staffing expertise including availability, experience, formal and other training. 2. Curriculum Vitaes (CVs) of Offeror(s) Site Monitors that demonstrate CRA experience in performing clinical site and study monitoring activities described in the project description and Site Monitors' attrition rates. 3. Current in-house capability and available capacity to perform work; 4. A detailed discussion and documentation to support : a. Organizational experience and capability of successfully managing federal government contracts ; b. Organizational experience and capability of successfully performing clinical site and study monitoring functions/visits at international sites using FDA Regulations Relating to Good Clinical Practice, 45 CFR 46 Human Subjects Protection, and ICH E6-GCP Guidelines. c. Experience developing Standard Operation Procedures and reports for routine and specialized clinical site monitoring visits for similar projects. d. Experience developing staff training plans e. Experience in developing and implementing Quality Assurance and control procedures 5. Respondent's DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUB Zone, small disadvantaged, etc...) pursuant to the NAICS 541990 NOTE: THE APPLICABLE NAICS CODE FOR THIS REQUIREMENT IS 541990 (Industry Description- All Other Professional, Scientific, and Technical Services with Size Standard of $14.0 Million) 6. Any additional information or resources available to your organization for consideration of your potential capability in fulfilling this requirement. 7. Your organization's technical and administrative points of contact, including names, titles, addresses, telephone, and fax numbers, and email addresses. You are encouraged to limit your response to fewer than ten (10) pages and must specifically address items 1 through 7 of the requirement specific items requested. Please include "Responses to Sources Sought Notice HHS-NIH-NIDA(SSSA)-2014-097" in the subject line. Responses to this notice should be received no later than the posted due date, and shall be sent electronically via email to: Jeffrey Williams Contracting Officer Email: jeffrey.williams@nih.gov Phone: 301-402-1677 F. 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, response to this notice will not be considered adequate responses to a solicitation.
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