A02_Synopsis_Amendment_0001.pdf

Synopses/Pre Solicitation No. W81XWH19R0011PRE, Amendment 0001

Synopses/Pre Solicitation for Clinical Trial Support Services

DISCLAIMER: THIS IS STRICTLY A SYNOPSES/PRE-SOLICITATION NOTICE OF THE

GOVERNMENT’S INTENT TO SOLICIT FOR CLINICAL TRIAL SUPPORT SERVICE. THIS

IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ).

NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE

CONSIDERED IN RESPONSE TO THIS ANNOUNCEMENT. CONTRACTOR QUESTIONS

ARE NOT PERMITTED OR WILL BE RETURNED.

In accordance with Federal Acquisition Regulation (FAR) 5.207 entitled, “Preparation and Transmittal of synopses” the following information is being provided:

Action Code: Service (non-commercial/non-personal) Today’s Date: Monday, 18 March 2019 Contracting Office: U.S. Army Medical Research Acquisition Activity (USAMRAA) 1504 Porter Street Fort Detrick, MD 21702 Product Service Code (PSC): AN11 Proposed “future” Solicitation Number: W81XWH19R0011 Closing Response Date: Not applicable Contracting POC: Julie Burns at julia.l.burns3.civ@mail.mil Contract Award Number: unknown at this time Contract Award Dollar Amount: unknown at this time Line Item Number: unknown at this time “Estimated” Contract Award Date: 2nd Quarter 2019 Contractor: unknown at this time Set-Aside Status: Small Business Set Aside

Description Information:

(a) Purpose/Subject: U.S. Army Medical Research Acquisition Activity (USAMRAA) on behalf of Walter Reed Army Institute of Research (WRAIR) intends to solicit for on and off-site clinical trial support services which include, but is not limited to administrative, technical, regulatory, statistical analysis, clinical, and facility support under the authority of FAR 15 entitled “Contracting by Negotiation.”

(b) Background: WRAIR is the largest and most diverse biomedical research laboratory in the Department of Defense. Our main facility, the Daniel K. Inouye building, is located in Silver Spring, Maryland. Other laboratory and clinical facilities carry out research in Asia, Africa, and Europe through cooperative partnerships with host governments and militaries through the US State Department. Our greatest resources are the dedicated scientists, technicians, and support personnel who make up the core of the WRAIR today.

By integrating basic research and advanced technology for the primary goal of protecting the Warfighter, the WRAIR serves as the premier biomedical research organization within the

Department of Defense. The Institute hosts both the Center for Infectious Disease Research and the Center for Military Psychiatry and Neuroscience Research. With headquarters in Silver Spring, Maryland, laboratories are also hosted in subordinate directorate locations in Washington State, Thailand, Germany, the Republic of Georgia and Kenya.

The Clinical Trials Center (CTC) was established as a clinical research unit in early 1992 to support Army and Navy investigators in their mission to develop new vaccines, drugs and diagnostics systems that will benefit not only the military, but all people. An average of 13- 15 clinical studies are annually conducted by the CTC. To implement these studies, the CTC enrolls an estimated 350 volunteers per year, contacts more than 1,000 new volunteer per year, and nearly 5,000 clinical visits per year. While much of its work provides clinical research data for infectious disease threats, it works with any clinical warfighter-relevant medical countermeasure to include Traumatic Brain Injury and Sleep. There are approximately 9.4 million globally located DoD beneficiaries within the Military Healthcare System (MHS). This diverse population can benefit from biomedical research discoveries targeted to this population. In addition, military medical research has provided tremendous benefits not only to the military beneficiary population, but also the global population. For example, military researchers have had a hand in the development of every anti-malarial ever used in humans. Furthermore, these same researchers have developed key vaccines, such as Hepatitis A and Japanese encephalitis. Military researchers played a significant role in the development of forty percent of the adult vaccines currently in use today, and greater than half the vaccines routinely administered to military personnel were co-developed by the military.

Tasks:

Task 1 – Technical Support Services. The contractor shall provide qualified personnel to implement all aspects of clinical trial activities in compliance with human subjects’ protection regulations and provide a level of quality that will result in successful regulatory submissions for product development.

Task 2 – Protocol Compliance. The contractor shall ensure that all clinical trial protocols are compliant with regulatory standards and ethical principles. Documents and management processes shall comply with regulatory requirements, both Federal and DoD-specific. Submissions shall be made in coordination with the integrated product teams (IPTs) when appropriate, sponsor representatives, and participating scientists. Prepared documents shall be appropriate for the purpose, accurate in content, and timely in submission. Records of the process and archives of the product shall be maintained according to quality and applicable standards such as Current Good Clinical Practice (cGCPs), Current Good Manufacturing Practices (cGMP), and Current Good Laboratory Practices (cGLP) regulations.

Task 3 - Professional Licensures and Certifications. The contractor shall provide credentialed Registered Nurses licensed to practice in the state of Maryland, who are skilled and qualified in nursing procedures to include, but not limited to phlebotomy and the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314. The contractor shall provide Physicians with unrestricted licenses to practice in the state of Maryland in support of all clinical trials. All qualified personnel shall meet all credentialing requirements.

Task 4 – Recruiting and Advertising. The contractor shall enroll sufficient numbers of healthy, qualified volunteers to meet the requirements of all clinical studies. The Contractor shall devise and implement recruiting strategies to identify potential research volunteers and provide valid estimates of their cost. The contractor shall have the capability of designing and producing effective advertising products to be used in modern media venues.

Advertising shall be done within defined study budget parameters as well ethical and legal guidelines.

Task 5 – Volunteer Compensation. The Contractor shall provide payments with funds that reside in U.S. dollars and are FDIC-insured, to volunteers for screening or participating in ongoing research studies in accordance with the amounts and schedule(s) specified in each protocol. Payments shall be tracked and auditable in accordance with all applicable Internal Revenue Service (IRS) reporting requirements. Volunteers shall receive full payment authorized for study visits at the completion of the visit in a form that each volunteer can access their payment immediately, do not need a bank account to use, and can be accepted universally.

Task 6 - Post-donation and Post-vaccination Snacks and Beverages. The contractor shall provide snack-sized food items and beverages to all volunteers approved to participate in randomized, control trials and blind studies.

Task 7 – Arrange offsite Residential Accommodations. The contractor shall arrange for offsite accommodations (e.g., hotel, leased space, etc.) necessary to implement residential research studies. The Contractor shall make all appropriate arrangements to secure the needed accommodations to house the volunteers and support personnel required to fully comply with protocol procedures.

Task 8 - Clinical Laboratory Services. The contractor shall provide College of American Pathologists (CAP) / Clinical Laboratory Improvement Amendments (CLIA) certified clinical laboratory testing to support research studies with turnaround times and reporting methods equivalent to a standard clinical setting.

Task 9 – Design Study Forms. The contractor shall provide source documents and case report forms for studies meeting data collection needs of each protocol. When required for a study, the contractor shall work with teams of investigators and Sponsor personnel to design study forms that collect the required data for each study.

Task 10 – Statistical Support Services. The contractor shall develop a Statistical Analysis Plan and Program Validation Plan that contain statistical programming specifications and the statistical programs used to produce the tables, listings and figures (TLFs) as well as all ad hoc analyses and reports requested by the Sponsor and/or the FDA. The contractor shall consider coding conventions and formats used in the statistical programs.

Task 11 – Records Management. The Contractor shall be responsible for the management of clinical study records (e.g., Clinical Trial Master File) through final archival, ensuring compliance with current regulatory requirements such as FDA and USAMRMC guidelines.

With a focus on inspection readiness, the Contractor shall receive, catalog, organize, digitize, and retire archival holdings and shall be responsible for preparation of documentation required for regulatory agency inspection, internal requests, and audits. The contractor shall provide periodic quality assessments and document management oversight.

Task 12 – Clinical Monitoring. The contractor shall review information related to the site qualification, review issues at the study site, perform a site initiation visit with the Sponsor/Investigator, conduct an interim monitoring visit and perform a close-out visits.

Task 13 - Subject Matter Experts (SMEs) and Consultants. The contractor shall be responsible for hiring subject matter experts (SMEs) and Consultants for professional consultation services to support the successful development and execution of clinical trials.

Task 14 - Phlebotomy. The contractor shall perform phlebotomy for simple and full blood unit collections using standard techniques (e.g. straight and/or butterfly needles) and universal precautions for approved research protocols as well as for specimen preparation.

Task 15 – Regulatory Affairs. The contractor shall prepare regulatory submissions required for product development and marketing new therapeutic modalities in both domestic and international markets. The contractor shall develop and implement strategies with the goal of regulatory submission approval.

Task 16 - Mobile Therapeutic Apheresis Services. Mobile Apheresis services shall include Plasmapheresis, Cytapheresis, Photopheresis, low density lipoproteins (LDL) Apheresis, and Hematopoietic Progenitor Cell (HPC) harvest.

Task 17 – Financial Management. The Contractor shall provide cost estimating and analysis support and guidance for projects. Support may include, but not limited to independent cost assessments of programs and projects and update trials estimates. The Contractor shall have or the ability to develop and maintain an integrated system of financial services including accounting, budgeting, and financial reporting. The contractor shall formulate, justify, and monitor the execution of trial budget plans, develop detailed estimates and narrative justifications as well as plan and monitor funds for program goals.

The contractor shall have a system capable of tracking ALL clinical trials’ full cost and related drivers to minimize the delays associated with unexpected events such as delays in volunteer enrollment and underperformance. The contractor shall forecast sites, subjects and project expense amounts.

Task 18 - Microscopy Services. The contractor shall utilize appropriate microscopy standard operating procedures (SOPs), study specific procedures (SSPs), standard techniques and universal precautions for all research protocols.

Task 19 - Clinical Trial Management System. The Contractor shall provide access to electronic scheduling tool capable of meeting all volunteer scheduling needs, screening logs, screening status, appointment status, and be capable of providing reports necessary for clinical trial regulatory filings. In addition, the system needs to be accessible to all clinical research monitors and have appropriate privacy safeguards to satisfy the Health Insurance Portability and Accountability Act (HIPAA) requirements.

Task 20: Administrative Support Services. Provide general administrative support in processing travel requests, regularly update accountability reports, and conduct market research on consumable purchase requests. Assisting the government staff with formatting various memorandums and disseminating message notifying staff of specific milestones and deadlines. Greet and escort volunteers and provide direction as needed. Schedule and track study volunteer appointments, make reminder phone calls to volunteers regarding upcoming appointments. Prepare and/or assist in the design and update of various study documents. Maintain and update front desk and MS Outlook calendars as needed. Enter required data in Case Report Form (eCRFs) and audit records for accuracy, resolve discrepancies, correct as necessary.

Award Type: Single Award Indefinite Delivery/Indefinite Quantity (SA-IDIQ)

Task Order Type: Hybrid (Firm Fixed Price and Cost Plus Fixed Fee).

Task Orders issued under this SA-ID/IQ will be either FFP or CPFF based on on whether to conditions of FAR 16.301-2, Cost Reimburshment Contracts are present and FAR 16.306(b) Cost Plus Fixed Fee. Task orders issued under this contract may be of the following types:

Firm-Fixed-Price (FFP) – Non-Commercial or Commercial Cost-Plus-Fixed-Fee (CPFF) – Non-Commercial

Qualifications Requirements/Eligibility: Contractor Business System – Due to the potential of “Cost” type task orders the acquisition is subject to the Cost Accounting Standards. Therefore, the Offeror shall meet the criteria set forth in Defense Federal Acquisition Regulation Supplement (DFARS) clause 252.242-7005 entitled, “Contractor Business Systems.”

(1) Accounting System - All Offerors shall or the ability to obtain an adequate accounting system as defined in the Defense Federal Acquisition Regulation Supplement (DFARS) Clause 252.242-7006(a)(1), entitled, “Accounting System Administration” AND meet the system criteria at DFARS 252.242-7006(c) in order to be eligible for an award.

Additionally, in accordance with DFARS 252.242-7006(b), “all Offerors shall establish and maintain an acceptable accounting system. All Offeror may be required to provide evidence of its accounting system adequacy (reference DFARS 252.242-7006(c), FAR 16.3 and FAR 31). Examples of evidence include, but not limited to: (a) Third party audited financial statements to include audit of accounting system and methods, and/or (b) Current Defense Contract Audit Agency (DCAA) cost accounting system audit report, and/or (c) Current certification from DCAA/Standard Form 1408. Failure to maintain an acceptable accounting system, as defined in this clause, shall result in the withholding of payments and also may result in disapproval of the system.

(2) Earned Value Management System – not applicable.

(3) Estimating System - All Offerors shall or the ability to obtain an estimating system as defined in the DFARS 252.215-7002(a). Failure to maintain an acceptable accounting system, as defined in this clause, shall result in the withholding of payments and also may result in disapproval of the system.

(4) Material Management and Accounting System (MMAS) - All Offerors shall or the ability to obtain a Material Management and Accounting System as defined in the DFARS 252.242-7004(a) and meet the system criteria at DFARS 252.242-7004(d) in order to be eligible for an award. All Offeror may be required to provide evidence of its MMAS (reference DFARS 252.242-7004(c)) adequacy. Examples of evidence include results of internal reviews. Failure to maintain an acceptable MMAS, as defined in this clause, shall result in the withholding of payments and also may result in disapproval of the system.

(5) Property Management System – All Offerors shall or the ability to obtain a Property Management System as defined in the DFARS 252.245-7003(a) and meet the system criteria at DFARS 252.245-7003(c) in order to be eligible for an award. Failure to maintain an Property Management System, as defined in this clause, shall result in the withholding of payments and also may result in disapproval of the system.

(6) Purchasing System – All Offerors shall or the ability to obtain a Purchasing System as defined in the DFARS 252.244-7001(a) and meet the system criteria at DFARS 252.244- 7001(c) in order to be eligible for an award. Failure to maintain an Purchasing System, as defined in this clause, shall result in the withholding of payments and also may result in disapproval of the system.

Subcontracting Plan: Not applicable. (reference FAR 19.702(b)(1)). This acquisition encourages subcontracting or teaming arrangements in accordance with (IAW) FAR 19.702 entitled, “Statutory Requirements” which states, that “Any contractor receiving a contract with a value greater than the simplified acquisition threshold must agree in the contract that small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns will have the maximum practicable opportunity to participate in contract performance consistent with its efficient performance.” Additionally, in accordance with FAR 52.219-14, entitled, “Limitation in Subcontracting,” the Offeror/Contractor agrees that in performance of the contract that at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern.

Medical Liability Insurance/Indemnification: All Offeror shall indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance and shall be required to maintain medical liability insurance, in a coverage amount acceptable to the contracting officer, which is not less than the amount normally prevailing within the local community for the medical specialty concerned. The Offeror shall ensure that its subcontracts for provisions of health care services, contain the requirements of the clause at FAR 52.237-7, including the maintenance of medical liability insurance (reference FAR 37.401).

Period of performance: Base Year (5 years) with 2 renewable option periods.

North American Industry Classification Code (NAICS): 541715

Place of Contractor Performance: Multiple (to include, but not limited to Silver Spring, MD, contractor facility, and various off-site locations)

Basis of Award: Award of this SA-ID/IQ contract will be made on a competitive best value basis using “Best Value, Trade-Off” among price and non-cost/price factors. Thus, the Government may elect to award to other than the lowest priced Offeror, or other than the Offeror with the highest rated non-cost/price proposal. Past Performance will be evaluated independently from other non-cost/price evaluation factors using different standards.

ALL RESPONSBILE SMALL BUSINESS SOURCES MAY SUBMIT A PROPOSAL AT

TIME OF SOLICITATION. OFFEORS ARE RESPONSBLE FOR MONITORING THE

SITE FOR THE SOLICITATION POSTING AND RESULANT AMENDMENTS.

FAILURE TO RESPOND WITHIN THE DUE DATE AND/OR SUBMISSION OF ALL

REQURIED CONTENT, WILL RESULT IN REJECTION OF THE PROPOSAL.