CRSS Sources Sought Notice Final.pdf

SOURCES SOUGHT NOTICE

Sources Sought Reference Number: HHS-NIH-NIAID-75N93021R00001

Agency/Office Department of Health and Human Services, National Institutes of Health, NIAID

Contracting Office Address Office of Acquisitions Division of Extramural Activities, NIAID 5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, MD 20892-9821

Type Research & Development Sources Sought

Solicitation Number

HHS-NIH-NIAID-75N93021R00001

Title NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS)

Classification Code A – Research & Development

NAICS Code 541715 – Research and Development in the Physical, Engineering and Life Sciences (except Nanotechnology and Biotechnology)

Posted Date: November 3, 2020 Response Date: November 18, 2020

Primary Point of Contact Rosemary Gomes, Contracting Officer rosemary.gomes@nih.gov 240-669-5374

Secondary Point of Contact Michelle L. Scala MScala@niaid.nih.gov 240-669-5156

Introduction This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources, including small and small disadvantaged businesses, to perform a potential R&D requirement.

Background The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), conducts and supports research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The mission of Division of AIDS mailto:rosemary.gomes@nih.gov mailto:MScala@niaid.nih.gov

(DAIDS), NIAID, is to bring an end to the HIV/AIDS epidemic by increasing the basic 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. NIAID/DAIDS, henceforth referred to as DAIDS, supports extramural Clinical Trials Networks, investigator-initiated clinical trials, and partners with other Government and private organizations, in order to accomplish DAIDS’s scientific objectives. 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. The DAIDS global clinical trial portfolio includes approximately 440 active protocols, 73 active INDs, 300+ network study sites in 22 countries, and collaborations with 60 pharmaceutical companies. As the Investigational New Drug (IND) Application Sponsor for a large number of DAIDS-funded clinical trials, DAIDS is required to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and ICH E6(R2) International Conference on Harmonisation-Good Clinical Practices (ICH-GCP).

This Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has an existing contract (Contract No.

HHSN272201700078C) for “NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS),” with PPD Development, LP, 929 North Front Street, Wilmington, North Carolina. This contract was awarded on a competitive basis, for a seven-year period, from August 15, 2017 through August 14, 2024. A term type/level of effort contract was awarded for the delivery of 48.10 Full Time Equivalents (FTEs) per year. The contract also included quantity options to increase the level of effort by a total of 6.0 FTEs each year for significant unanticipated increases in demand.

The purpose of the contract is to provide both a broad range, as well as gap-filling, clinical and other related research support services for the NIAID/DAIDS-supported clinical research portfolio and other infectious diseases that are of relevance to HIV infection and at risk populations, and to assist NIAID in the development and maintenance of a strong and responsive clinical infrastructure.

On July 10, 2020, in response to the COVID-19 pandemic, the contract was modified to procure full clinical trial support services for a sponsored DAIDS COVID-19 clinical trial entitled “A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)” also known as ACTIV- 2). This clinical trial is one of the studies identified by Operation Warp Speed to move towards identifying a therapeutic for COVID-19 as quickly as possible. The support provided includes the following major service areas:

• Project Management - Overall management/coordination of ACTIV-2 service areas.

• Medical Writing - Assist with final protocol language.

• Clinical Site Selection/Feasibility/ Assessment/Contracting -Transition domestic/international sites from initial site contact to final site activation. Activities include feasibility surveys, site assessments, site readiness evaluation (Lab, pharmacy, clinical), pre-study visits, central IRB submissions support, investigator agreements and assist sites with protocol registration.

• Clinical Data Management - Manage Electronic Data Collection System (Medidata Rave) throughout project lifecycle to include database design/build, eCRFs development, design/build of edit check specifications, database freeze/lock and additional related activities.

• Recruitment - Develop site-specific Site Recruitment Activation Plans (SRAP), engage Accelerated Enrollment Solutions (AES) as well as additional entities for full community engagement and public relations efforts.

• Clinical Site Activation/Training – Develop/conduct Protocol-Specific, Electronic Data Capture (EDC), and Specimen Management training.

• Clinical Site Management- Provide site-specific quality metrics/analytics; oversee Protocol Deviation (PD) Management (collection, adjudication and documentation) including CAPA activities, manage Investigator payments, assume responsibility for non-IP clinical supplies.

• Medical Monitoring/Safety Oversight - 24-hour/7-day medical safety availability, develop safety management plan (SMP)/expedited and periodic safety reporting plan (ESRP), set up/maintain safety database, perform medical review of safety listings; SAE/event processing: receipt and follow-up assessment, data entry, narratives. Safety report generation/submission to applicable regulatory authorities and trend analysis.

• Clinical Site Monitoring - Conduct routine site monitoring visits to ensure compliance with regulatory requirements/guidelines, verify accuracy and completeness of clinical trial data, and assess adherence to protocol-specific requirements. Utilize Clinical Trials Management System (CTMS) to plan, manage, track study progress from Start-Up, through enrollment and monitoring, to study close.

• Electronic Trial Master File - Maintain all project-specific documentation. Oversee document storage, tracking, and management; produce document reports/ dashboards.

• Quality Assurance/Control –Maintain standards of quality that conform to internal/external guidelines and standards, verify/ensure that PPD services are performed in compliance with ICH/GCP requirements/regulations

• Laboratory Services- Prepare Central Lab Specifications document, supervise all study setup activities. Monitor active lab activities.

• Final Clinical Study Report – Assist with preparation of the Final Clinical Study Report.

A total of 202,656 direct labor hours or 108.72 FTEs were added to the contract to address this COVID-19 requirement for the period July 10, 2020 through June 30, 2021. The additional work was added to the contract on a sole source basis as a result of the HHS Class J&A for unusual and compelling urgency for the COVID-19 Response (please see the attached HHS Class J&A as well as the NIAID’s Addendum to the Class J&A).

This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NIAID.

Purpose and Objectives The purpose of this Research and Development (R&D) Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted.

As a result of this R&D Sources Sought Notice, the NIAID may issue a Request for Proposals (RFP) if it is deemed necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID’s use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement.

At this time, the complexity as well as quantity of requirements for support services for ACTIV- 2 have significantly increased based on “real time” clinical trial implementation data as well as evolving scientific requirements. Specifically, the following significant increases of ACTIV-2 key clinical trial activity drivers have transpired since July 10,2020:

• Number of sites – over 346% increase in the number of Phase 2 sites (41 to 183) and over 317% increase in the number of Phase 3 sites (96 to 400);

• Number of screened patients – over 13% increase for Phase 2 screened patients

(2,201 to 2,492) and over 57% increase in Phase 3 screened patients (8,901 to 14,000);

• Number of enrolled patients – over 33% increase for Phase 2 enrolled patients (1,320 to 1,760) and over 87% increase in Phase 3 enrolled/completed patients (5,340 to 10,000);

• Monitoring requirements – over 33% increase in Phase 2 monitoring requirements and over 67% increase in Phase 3 monitoring;

• The period of study is extended from December 31, 2021 to May 31, 2022.

As a result of these increases in clinical trial support activities, the Government will require additional support to address these needs. The objective of this acquisition is to procure 360 FTEs to be delivered to the Government during the period March 1, 2021 through May 31, 2022. These additional resources are needed to provide the support as listed above.

Project requirements

Specifically, the Contractor will be responsible for continuing to provide clinical research support activities for the ACTIV-2 to include the following activities:

• project management,

• medical writing,

• clinical site selection/feasibility/assessment/contracting,

• clinical data management,

• recruitment,

• clinical site activation/training,

• clinical site management support,

• medical monitoring and safety oversight support/call center,

• clinical site monitoring,

• electronic trial master file (eTMF),

• Quality Assurance/Control,

• laboratory services and

• provision of the final clinical study report.

The NIAID intends to modify the existing PPD Development, LP contract to provide an increase to the required Level of Effort by approximately 251.4 FTEs for the period March 1, 2021 through June 30, 2021 and approximately 108.6 FTEs for the period July 1, 2021 through May 31, 2022.

Anticipated period of performance The period of performance of the existing contract will not change. The increase in FTEs is anticipated to occur during the period March 1, 2021 through May 31, 2022.

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 immediately 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 to deliver comprehensive services of this scope and magnitude; 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 immediately 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 Project Director and Project Managers, 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., large business, non-profit, educational institute, 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/

Responses must be submitted no later than 3:00 PM (Local Time), November 18, 2020.

Capability statements will not be returned and will not be accepted after the due date.

These statements should be submitted electronically (via e-mail) to Rosemary Gomes, Contracting Officer, at rosemary.gomes@nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify HHS-NIH-NIAID- 75N93021R00001. 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 November 18, 2020. 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 http://www.sam.gov/ mailto:rosemary.gomes@nih.gov 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:

Contracting Officer: Rosemary Gomes Email Address: Rosemary.Gomes@nih.gov

Contracting Officer/Team Leader: Michelle L. Scala Email Address: MScala@niaid.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.

mailto:Rosemary.Gomes@nih.gov mailto:MScala@niaid.nih.gov