(NIAID), Division of Clinical Research (DCR) Administrative & Technical Research Support Services

1. 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 Capability Statements for Market Research purposes regarding: a. Availability and capability of qualified small business sources; b. 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 c. 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. The planned North American Industry Classification System (NAICS) code for this acquisition is 541690 Other Scientific and Technical Consulting Services with a small business size standard is $6.5 million. 2. Background. The National Institute of Allergy and Infectious Diseases (NIAID), Division of Clinical Research (DCR), rapidly deploys administrative & technical research support services and resources to meet the external demands placed on the NIAID to conduct time sensitive, high priority, global, collaborative clinical research critical to the mission of the NIAID and advancement of the National Institutes of Health (NIH) and Department of Health & Human Services (DHHS) Global Health Agendas. Fulfillment of this mission requires DCR to have the capacity to expeditiously facilitate collaborative clinical research both domestically and internationally. a. Purpose. The purpose of this requirement is to provide the capacity to proactively identify and establish administrative and management services to support current DCR efforts in one of the four designated areas of Southwest Asia, Southeast Asia, Central and South America, Africa as well as to rapidly establish collaborations with international government agencies, academia, and health research entities in developing countries in response to urgent research demands of global importance. The potential also exists that a portion of the future tasks will be performed within North America. b. Objectives. 1. Establish the capacity to proactively identify and establish technical and administrative management services for NIAID'S collaborative research efforts 2. Provision the Division of Clinical Research (DCR) and NIAID's Offices, Divisions, and Centers with the capability and capacity to rapidly establish resources for collaboration between the NIAID and government agencies, academia, and other health research entities domestically or internationally. c. Goal. It is the goal of the NIAID's DCR to establish a multiple-award IDIQ contract with a base ordering period of five years, from the date of award that fulfills the future operational and research requirement of the institute. d. Project Requirements. i. Scope. The services required will include broad range of administrative and management services needed to support collaborative clinical research. Services will include clinical site assessments, clinical site preparation, study/trial operational assistance, provision of technical expertise, providing training on topics related to clinical research, as well as administrative and management support functions. ii. Focus. This requirement may be comprised of the following types of Administrative and Management Services: a) Clinical Site Assessment. Assess the sites/locations in order to determine the administrative and technical services required to support the NIAID Special Projects. b) Clinical Site Preparation. Collaboration with, and/or response to, NIAID Network Partners and/or DCR staff requirements for technical services. i. Coordinate Activities to align with other DCR operational processes in consultation with the DCR COR. ii. Provide scientific and technical consultants, as needed, IAT provide the technical research support as set forth by the collaborating investigators. c) Training. Provide training related to the design and implementation of clinical studies/trials for future designated sites. d) Programmatic and Logistical Support. Provide administrative and programmatic specific support as needed, comprised of the following: - Administrative support - Meeting support - Site Communication Support Services - Infrastructure Support - Data Management and Information Technology Services - Protocol Review Support - Material Distribution - Shipping - Courier Services - Travel Support Services iii. Reports and Deliverables. The following reporting and deliverable will be provided in Microsoft Word, Excel 2007 or higher requirements: - Clinical Site Assessment Tool -First draft is due 30 business days after Contract award. Final due is due five business days after receipt of Government comments - Site Needs Assessment Analysis & Report - First draft is due within 30 days after completion of assessment, - Protocol SOPs, & Manual of Procedures - First draft is due 30 days after Task Order award. Final due is due five business days after receipt of Government comments, - Adverse Events (AEs) & Serious Adverse Events (SAEs) Reporting System - First draft is due 30 days after Task Order award. Final due is due five business days after receipt of Government comments, - Training Needs Assessment Report - First draft is due 30 days after Task Order award. Final due is due five business days after receipt of Government comments, - Training Material - First draft is due 30 days after Task Order award. Final due is due five business days after receipt of Government comments, - Meeting Notes & Reports - First draft is due 30 days after Task Order award. Final due is due five business days after receipt of Government comments, - Translated Documents - First draft is due 5 days after initial document is received. Final copy is due five days after receipt of Government comments, - Program Support Material - First draft is due 30 days after Task Order award. Final is due five business days after receipt of Government comments, - Program Management Plan - First draft due 5 business days after Contract award. Final due five business days after receipt of Government comments, - Monthly Expenditure and Budget Reports - First draft due five business days after initial project meeting. Final report is due five business days after the receipt of Government comments, - Annual Report - Yearly, beginning thirty calendar days after the one-year Anniversary of the Task Order award, - Task Order Completion Report - First draft is due five business days after completion of a Task Order. Final report is due five business days after receipt of government request for clarification or finalization, - Report of Government Property - Yearly, beginning thirty calendar days after the one-year Anniversary of the Task Order award, - Completion Report - Within 60calendar days prior to end of contract performance period (base period or last Task Order), - Transition Plan - Within 60 calendar days prior to end of contract performance period (base period or last Task Order), - Quality Control Plan - First draft due 5 business days after Contract award. Final due five business days after receipt of Government comments, - Computer Security Plan - Within 30 calendar days of the Contract award iv. Personnel. The Contractor shall provide a qualified multidisciplinary staff, augmented with qualified consultants, as necessary and appropriate. Staff must have suitable, adequate, and demonstrated skills in all areas described. The Government anticipates that the following Key Personnel, with the requisite experience and skillset, will be required for successful performance of the requirement. a. Program Manager b. Project Manager c. Associate Researcher d. Training Associate Additionally, it is anticipated that the following positions will also be required; Physicians, Nurses, Data Managers, Biostatisticians, Regulatory Affairs Specialists, Bioethicists, Pharmacologists/Pharmacists, Information Technology (IT) Staff, Other Health Professionals as needed, Training Personnel, Laboratory Technicians. e. Period of Performance. The anticipated Period of Performance (PoP) is currently five years from the date of award. The (PoP) of the potential Task Orders are presently unknown. f. Other important considerations. The place of performance will be dictated by the requirement(s) of the future task orders. The tasks will be primarily performed within one of the four designated areas of Southwest Asia, Southeast Asia, Central and South America, Africa. The potential also exists that a portion of the future tasks will be performed within North America. It is likely that a contractor will be required to conduct simultaneous tasks in any of the geographic areas described. g. Capability Statement /information sought. Respondents shall provide a capability statement by date specified in this announcement. Capability statements must specify which portion of the requirement's description the offeror is capable of performing and demonstrate the offerors ability to perform the stated work. Respondents must specifically address their ability to maintain a large and highly diverse staff of administrative, scientific, logistical and technical personnel, and reasonably demonstrate their ability to perform at least 50 percent of the estimated work. DUNS number, NAICS codes and, business size must be indicated within the capability statement. Capability Statement should include: i. Information regarding respondents': ? Staff expertise, including their availability, experience, and formal and other training; ? Current in-house capability and capacity to perform the work; ? Prior completed projects of similar nature; ? Corporate experience and management capability; and ? Examples of prior completed Government contracts, references, and other related information; ii. Respondents' Capability Statements are required to provide their 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; The anticipated NAICS code for this requirement is 541690 - Other Scientific and Technical Consulting Services. Respondents may suggest other NAICS codes for use in our future solicitation. iii. Any questions and the respondents' Capability Statement must be provided as a Microsoft Word or as an Adobe PDF attachment. Telephone and facsimile responses will not be accepted. Responses must be emailed to the address below by March 11, 2015, 2 p.m. EST. Andrew Walmsley Contract Specialist 5601 Fishers Lane, Rockville, MD 20852 Phone (240) 669-5114 andrew.walmsley@nih.gov iv. Respondents are not required to include information outlines in their response. v. The maximum number of pages is fifteen (15) vi. Number of copies of the response required; One (1) vii. Respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses 3. Disclaimer and Important Notices: 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 to provide feedback to respondents with respect to any information submitted. After a review of the responses, a pre-solicitation synopsis and solicitation may be published in FEDBIZOPS. Responses to this notice will not be considered adequate responses to a solicitation. 4. 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)."