Source Sought Notice.pdf

Sources Sought Notice HHS-NIH-NCI-SBSS-ETSB-00025-46

Introduction

This is a Small Business Sources Sought (SBSS) 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; women-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. This requirement is assigned the NAICS code 518210, and the SBA size standard for such a requirement is an average annual receipt of $35 Million.

This Small Business Sources Sought Notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted.

The Capability Statements submitted in response to this notice should include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address) as well as the eligible business concern’s name, point of contact, address, and Unique Entity Identifier (UEI).

Background

The National Cancer Institute (NCI) is the federal government's principal agency for cancer research and training. Established under the National Cancer Institute Act of 1937, NCI is part of the National Institutes of Health (NIH), one of 11 agencies that make up the Department of Health and Human Services (HHS).

NCI’s mission is to lead, conduct, and support cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives. As the leader of the cancer research enterprise, collectively known as the National Cancer Program, and the largest funder of cancer research in the world, NCI manages a broad range of research, training, and information dissemination activities that reach across the entire country.

In 2008, the National Cancer Institute (NCI) procured a perpetual license for Medidata Rave for use by NCI sponsored organizations for oncology related research. The perpetual license grants to the NCI and its authorized users a perpetual use license to Medidata applications solely for unlimited usage rights within the boundaries of the NCI Clinical Research Enterprise for an unlimited number of studies.

Medidata Rave (herein after referred to as Rave) is an Electronic Data Capture (EDC) and Clinical Data Management System (CDMS) and is the primary tool utilized by researchers, physicians, and other health care professionals to communicate and track scientific and safety data related to experimental cancer trials. The primary NCI users of Medidata Rave are the National Clinical Trials Network (NCTN), Experimental Therapeutics Clinical Trials Network (ETCTN), National Community Clinical Oncology Program (NCORP), and several smaller NCI multi-center consortia.

To support the National Cancer Institute's (NCI) oncology related research, NCI is in need of hosting, maintenance, and professional services to support the NCI owned perpetual license for Medidata Rave, and the continued need for the following Medidata Rave-integrated products: Targeted Source Data Verification (TSDV) and electronic Patient Reported Outcomes (ePRO) and associated hosting, maintenance, and professional services. Please note that per the hosting policy available on its website, Medidata Solutions Inc. typically does not allow any other company to provide hosting and maintenance services for Rave and other proprietary products.

The services are currently being provided by Medidata Solutions, Inc. via task orders issued under the IDIQ contract HHSN261201800033I. The Government intends to award a single Indefinite Delivery/Indefinite Quantity (IDIQ) contract in order to continue these services. Task Orders will be issued in the Task Areas identified in the Project Requirements section below.

Purpose and Objectives

The purpose of the proposed contract is to provide:

a) Hosting, maintenance, and professional services for Medidata Rave for approximately 500 studies for several production and test URLs.

b) License, hosting, maintenance, and professional services for ancillary Medidata Rave-integrated software products that have been integrated with NCI IT infrastructure and business processes, identified below for use in NCI sponsored trials.

i. Targeted Source Data Verification (TSDV)

ii. Electronic Patient Reported outcomes (ePROs)

c) The Government may have a need for additional services including:

• New Medidata ancillary software products – License, hosting, maintenance; and professional/training services to support implementation.

• New URLs – Hosting, maintenance, and professional services for new Rave URLs and Medidata ancillary products.

• Additional Studies to leverage ancillary Software products.

• Additional Professional services

Project Requirements

The Contractor must be able to provide the full complement of services under the following task areas:

Task 1: License for Ancillary Products

The contractor shall provide a license for NCI use of Medidata Rave Ancillary products including TSDV and ePRO to be used on various URLs.

Task 2: Hosting

Hosting services in accordance with the NCI Medidata Rave Perpetual License for Medidata Rave and Ancillary products.

Task 3: Maintenance/Support Services

The Contractor shall provide expert level guidance and troubleshooting in connection with questions and issues arising from the Medidata Rave and Ancillary software. In addition, the Contractor shall provide a maintenance/communication plan.

Task 4: Professional/Training Services These services include but are not limited to:

a) Application training via face-to-face; webinar; and on-line support.

b) Application subject matter expertise, mentorship, and recommendations to develop, establish and maintain best practices and optimize efficiency and effectiveness in the use of Medidata products

c) Collaborate to provide mentorship; and promote, implement, and maintain system and operational integration of Medidata products

d) Incorporation of bug-fixes into Medidata proprietary product development schedule.

e) Representation to all NCI identified teleconferences and webinars.

f) Help Desk Support (24 hours/7 days a week)

Task 5: Additional URLs

Hosting, maintenance, and professional services for Medidata Rave, TSDV, ePRO and other ancillary software for additional URLs.

Task 6: Additional Rave-integrated ancillary software products

License, hosting, maintenance, and professional services for additional Medidata ancillary applications of interest.

Task 7: Additional studies for Rave-integrated ancillary software products

The contractor shall extend license(s) for selected ancillary software products to additional studies within the parameters of the license limitations.

Task 8: Training for evolving needs

Additional training to NCI staff, URL holders and research staff through a mix of face-to-face, webinar, on-line and teleconference

Task 9: Other Services

Other Services, including but not limited to the following such as:

a) Strategic Consulting Offerings inclusive of Risk Based Monitoring.

b) Study build / Configuration of Medidata products

c) Helpdesk support

d) Psychometric instrument licensing, translation and/or validation services.

e) Other product enablement training

f) Ad-Hoc Custom Script for Small and Large URL’s

Anticipated Period of Performance

It is anticipated that a single Commercial Services Indefinite Delivery/Indefinite Quantity (IDIQ) type contract with a five-year ordering period will be awarded with the ordering period starting on or about September 1, 2023. Only firm-fixed type Task Orders will be issued against the IDIQ contract.

Capability Statement/Information Sought

The Government encourages interested, qualified small business organizations to submit a tailored capability statement that addresses the task areas outlined above which will be considered by the agency.

Tailored Capability Statements submitted in response to this notice should supply pertinent information in sufficient detail to demonstrate the offeror’s ability to perform the required services.

Capability Statements should clearly convey information regarding the offeror's capabilities with respect to the task areas described in the project requirements section above. The capability statements should include responses to the following:

• Is your organization able to provide the full complement of services for all task areas identified in the Project Requirements section above?

• Does your organization provide hosting services for Medidata Rave and ancillary products?

• Does your organization provide maintenance (batch development) for Medidata Rave and ancillary products?

• Does your organization provide professional services for Medidata Rave and Ancillary Products?

• A brief description of what services related to Medidata Rave and ancillary products your organization provides.

Each response should include the following Business Information on the cover page:

a. Unique Entity Identifier (UEI)

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. Type of Company (i.e., 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/

f. Size classification relative to the North American Industry Classification System (NAICS) code 518210 for the proposed acquisition.

The capability statement shall not exceed five (5) pages, must be presented in single-spaced formatting and using minimum 12-point font size and shall clearly detail the ability to perform the aspects of the notice described above. The capability statements should be submitted in a PDF format.

The Capability Statements must be submitted no later than December 23, 2022, by 3:00 PM ET. All responses must be received by the specified due date and time in order to be considered. CAPABILITY

STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.

These capability statements shall be submitted by e-mail to Pooja Rathore, Contracting Officer at:

pooja.rathore@nih.gov . In the subject line, please reference the notice number: HHS-NIH-NCI-ETSB-

SBSS-00025-46

Facsimile responses will not be accepted.

http://www.sam.gov/ mailto:pooja.rathore@nih.gov

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 Presolicitation synopsis and solicitation may be published in the Government Wide point if Entry: sam.gov. 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: Chris Shih Email Address: chris.shih@nih.gov

Contracting Officer: Pooja Rathore Email Address: pooja.rathore@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:chris.shih@nih.gov mailto:pooja.rathore@nih.gov