Presolicitation Notice - 75N91023R00025.pdf

Pre-Solicitation Notice Number: 75N91023R00025

Title: Hosting, Maintenance, and Professional Services for Rave and Medidata Rave Integrated Ancillary Software

The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source, Medidata Solutions Inc., under the authority of FAR 6.302-1. Interested persons may identify their interest and capability to respond to the requirement. This notice of intent is not a request for competitive proposals. However, all proposals received will be considered by the Government. A determination by the Government not to continue with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely to determine whether to conduct a competitive acquisition.

Background

Medidata Rave (herein after referred to as Rave) is an Electronic Data Capture (EDC) and Clinical Data Management System (CDMS). An EDC/CDMS is the primary tool utilized by researchers, physicians and other health care professionals to communicate and track scientific and safety data related to an experimental cancer trial. 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 support/training services to support the NCI owned perpetual license for Medidata Rave, and the continued need for the following Rave-integrated products, Targeted Source Data Verification (TSDV), electronic Patient Reported Outcomes (ePRO) and hosting, maintenance and training/support services.

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 and ancillary software products are Medidata’s proprietary products. Medidata Solutions Inc. does not allow any other company to provide hosting and maintenance services for Rave and other proprietary products.

This notice of intent to award a sole source contract is not a request for competitive proposals; However, in accordance with FAR 5.207(c)(16)(ii), all responsible sources that feel they can provide all the services/products identified herein, may submit a capability statement/proposal/quotation which shall be considered by the agency. Capability statements/proposal/quotation shall be tailored to clearly convey its ability and/or experience to provide all the requirements identified herein.

Capability statements, proposals, or quotations shall be tailored to clearly convey the offeror’s ability and/or experience to provide all the requirements summarized below. The Contractor shall provide:

a) Hosting, maintenance, and professional services for Rave for over 750 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 approximately 10 Rave URLs, for use in NCI sponsored trials.

i) Targeted Source Data Verification (TSDV)

ii) Electronic Patient Reported Outcomes (ePRO)

c) The Government may have need for other Medidata products/services, including:

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

• 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.

These services are currently provided by Medidata Solutions, Inc. under the Task orders HHSN2610001/75N91018F00001 and 75N91020F00002 issued under the IDIQ contract

75N91018D00033/HHSN261201800033I.

Project Requirements

The Contractor shall independently provide the full complement of services under all the nine (9) task areas listed below. The activities include and are not limited to the following:

Task 1: License for Ancillary Products

The contractor shall provide a license for NCI use of Medidata Rave Ancillary software 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 software 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

The period of performance (ordering period) for the IDIQ contract shall be from September 1, 2023 – August 31, 2028.

Qualified firms must also include the following information in their capability statements/proposal/quotation:

a. Company Name.

b. DUNS Number.

c. Company Point of Contact, mailing address, telephone number, and website address.

d. Name, telephone number, and email address of a company point of contact who has the authority and knowledge to clarify responses with Government representatives.

e. Date submitted.

f. Applicable GSA Schedule number or other available procurement vehicle.

g. Do you have a Government approved accounting system? If so, please identify the agency that approved the system.

h. Type of Company (i.e., other than small business, small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM).

i. All respondents must be registered and validated on SAM (https://www.sam.gov).

https://www.sam.gov/

The intended procurement is classified under NAICS code 518210.

The resultant contract will be awarded using the procedures as prescribed in FAR Part 12 - Acquisition of Commercial Items and FAR Part 15 - Contracting by Negotiation and will include all applicable provisions and clauses in effect though FAC 2023-01 (effective December 30, 2022), and HHSAR (effective December 18, 2015). It is the responsibility of the Contractor to be familiar with the applicable clauses and provisions. The Clauses may be accessed in full text at these addressed: FAR -https://www.acquisiton.gov/far and HHSAR - https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

No solicitation document is available. The information received will not be returned and will be retained as Market research. Capability statements/proposals,/quotations must be submitted to the contact point at the email address given below. Capability statements/proposals/ quotations will not be accepted after the due date. The maximum number of pages for submission is three (3) pages. All Capability Statements/Proposals/Quotations must be in Adobe Portable Document Format (PDF). All responses must be received by the specified due date and time in order to be considered. If no capability statements/proposals/quotations are received which specifically demonstrate the ability to meet all the requirements above, the Government shall proceed with a sole source contract to Medidata Solutions, Inc.

All responses must be submitted electronically to Pooja Rathore at pooja.rathore@nih.gov and Chris Shih at chris.shih@nih.gov by 3:00 PM Eastern Time on February 17, 2023 and must reference Notice Number 75N91023R00025. Hardcopy or faxed responses will not be accepted.

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..

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).

Contracting Office Address

National Cancer Institute (NCI), Office of Acquisitions (OA), 9609 Medical Center Drive, Rockville, MD.

https://www.acquisiton.gov/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html mailto:pooja.rathore@nih.gov mailto:chris.shih@nih.gov