Amendment 00001 RFP 75N91022R00023.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

00001

Pooja Rathore, Contracting Officer

The purpose of this amendment is to: (a) provide responses to questions received, (b) update RFP Attachments 1 and 6, and

(c) Revise RFP Articles C.2.b.A. and H.9.1.5. for position sensitivity designations and revise the location of Attachment 14 in Section J.

Office of Acquisitions National Cancer Institute National Institute of Health 9609 Medical Center Rockville, MD 20850

To All Potential Offerors 75N91022R00023

1 11

10/14/2022

09/27/2022

RFP: 75N91022R00023

AMENDMENT 00001

I. QUESTIONS AND ANSWERS:

The table below provides answers to the questions submitted in response to RFP 75N91022R00023

Question Number

RFP

Reference

Section Number Question/Clarification Government Response

1 Attachment

II. A. 4 and 5 Can the government confirm 11 point TNR will suffice for paragraph text and 10 point Arial will suffice for graphics/tables?

Please format the proposal in accordance with the Section II.A. of Attachment 1: Packaging and Delivery of Proposals- included in the

RFP.

2 RFP Section L. C. Business Proposal Instructions,

4. Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data,

pg. 69

Assuming the Government receives adequate price competition, please confirm the Certificate of Current Cost or Pricing is not required. If the Government does not receive adequate competition, please confirm the Certificate of Current Cost or Pricing can be submitted after any negotiations prior to award.

In accordance with the RFP, if there is adequate price competition, Certificate of Current Cost or Pricing Data (CCPD) will not be required, however, the Government reserves the right to request the CCPD if the CO determines that there is a need for it.

3 RFP NOTICE TO

OFFERORS, Page 4

The RFP states, “to facilitate communications, it is requested that the 8(a) participant submitting this offer/bid provide the following information regarding the firm's cognizant servicing Small Business Administration (SBA) office.”

Please confirm if the government is asking offerors to provide our SBA Representative information in the proposal. If so, where should it be included within offerors response?

Yes, please provide the information in the cover page of your business proposal.

4 RFP Section L, c.

BUSINESS PROPOSAL

INSTRUCTIONS, 4.

Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20

There are conflicting requirements for the cover page instructions in the RFP, can the government please confirm that Table 15-2 is not required to be part of the cover page as it is not listed as a requirement under a. General Instructions, section 2.1. Cover Page?

Table 15-2 is not required to be included in the cover page of the business proposal. Please see paragraph 2. for Proposal Cover Sheet requirements on Pg. 67 of the RFP and paragraph 3. and 4. on pgs.

67-69 of the RFP for the

RFP

Reference

Section Number Question/Clarification Government Response

(Nov 2021) requirements for Data Other Than Certified Cost or Pricing Data that needs to be included in the business proposal. Also see response to Question 2 above.

5 Attachment

Summary of Related Activities

The government does not specify in instructions where Attachment 8, Summary of Related Activities should be included in our technical proposal. Can the government please confirm where they would like bidders to include this completed attachment?

Please include Summary of Related Activities as an appendix to your Technical Proposal. RFP Attachments 1 and 6 are updated.

6 RFP Part IV- Representations and Instructions, Section L-Instructions, Conditions and Notices to Offerors,

2. Instructions to Offerors, B. Technical Proposal Instructions,

5. Section 508 accessibility standards for HHS Web Site Content and Communications Materials

There are no specific requirements for how to respond to Section 508 compliance in the Technical Proposal Instructions or in Attachment 6, Additional Technical Proposal Instructions. Can the government confirm that bidders do not have to respond within the Technical Proposal regarding Section 508?

Please see page 1 of RFP Attachment 6 - Additional Technical Proposal Instructions (ATPI). The offerors are not required to submit a VPAT or include a separate section for Section 508 conformance. However, the offeror's proposal needs to demonstrate conformance with Section 508 requirements. Please see RFP Articles C.2., H.10..

Also see paragraph 14. on pages 61 - 62 and paragraph

5. on page 66 of the RFP.

7 Attachment

Section 2 – Cost or Price Support - Estimated Level of Effort for Base and Term Options

The RFP states, “No additional fee will be paid for hours provided in excess of 100% up to 110% of the hours negotiated and included in the award.” Can the government clarify if the contractor goes over the 110% on hours but is still under the 100% on funding, will the contractor still receive the full fixed fee?

Fixed fee shall be paid in direct ratio to the agreed level of effort expended.

Please refer to RFP Attachment 14- Additional Business Proposal Instructions (ABPI) for explanation.

RFP

Reference

Section Number Question/Clarification Government Response

8 Attachment

Section 2 – Cost or Price Support – Training Assumptions (Page 116)

Per the training assumptions provided in the RFP, "For annual CIBMTR meetings, assume $250 registration fee (virtual) x 3 CDMs for $750 per year", will the Gov't please add additional CLINs for ODCs in the Base Year and all Option Years?

The Government does not intend to add CLINs for travel costs in the Base or Option Years. However, it is anticipated that the executed contract will include an advanced understanding indicating the authorized travel and corresponding amounts.

9 RFP L.1.(b)&(c) and L.2.a.10

Please provide/confirm the name of the incumbent contractor for the related current contract of this requirement.

Agile Decision Sciences, LLC, Contract Number #75N91020C00004, Expires January 14, 2023.

10 RFP L.1.(b)&(c) and L.2.a.10

Is the incumbent contractor eligible to bid on this solicitation?

This information is not relevant for the purposes of other offerors submitting a proposal in response to the

RFP.

11 RFP Do you have requirements for the size of subcontractors, and do they qualify to be our subcontractors (because of it’s large size)?

The offerors will need to comply with the applicable subcontracting limitation requirements. It is the offeror's responsibility to ensure that the Ostensible Subcontractor Rule is not violated. Please see FAR 19.809-2 and FAR Clause 52.219-14.

12 RFP Would you prefer that we store your data in the cloud for easy access from anywhere in the world, or would you prefer that we store it in a local location that you specify to keep it more secure?

The contractor will not store the data in their systems.

13 Where do the contractor's data management staff need to be located? All United States? In NCI offices? Are we able to make use of overseas resources?

Remote telework will be allowed. Contractor staff will have space on the Bethesda campus should they be requested to come in by the CCR. NO overseas resources are allowed.

RFP

Reference

Section Number Question/Clarification Government Response

14 Would the data management staff be working to NCI SOPs or would we need to generate appropriate SOPs & work instructions?

Contractor should have their own SOPs for the work but will need to follow specific CCR SOPs for certain tasks

15 What type of delivery model is expected for this engagement?

FTE?

The offeror's question is not clear. Government's requirement for the work set forth in the statement of work is based on level of effort. Please refer to RFP Section L and Attachment 14 - ABPI for additional detail.

16 If awarded, when would the work start, and what timeframe would be required for the ramp-up of the team?

The work must start on January 15, 2023 as there can not be a break in the support due to required data submissions. There is a 2 week transition-in time period between contractors.

17 How will contractor and/or subcontractor employees access systems required? Via contractor and/or subcontractor laptops with vpns? Will we be required to do any work within the contractor and subcontractor environments?

All contractors and/or subcontractors will be provided equipment and given appropriate access to systems within the CCR.

There be no requirement to do any work within the contractor and/or subcontractor environment.

18 General Would the Government consider the evaluation of subcontractor past performance and corporate experience?

Please see section L.2.a.12.

of the RFP regarding the Past Performance information that needs to be submitted. Past Performance will be evaluated in accordance with Section M of the RFP.

For Corporate Capabilities, please see Section L.2.c.8 (starting on pg. 75 of the RFP) and Attachment 6.

19 General Is the Government seeking management and organization of the Research Data Browser as

The Government is not seeking management and organization of the Research

RFP

Reference

Section Number Question/Clarification Government Response well? Data Browser.

20 Ref RFP, Section L:Instructions to Offerors.b.1.b.1

Is the Principal Investors/Project Manager considered the Program Manager (i.e. the person with complete oversight) for the contract.

There are two key positions, Program Manager (manages oversite of contract) and Project Manager.

21 Ref RFP, Section L:Instructions to Offerors.b.1.b.1, b.1.b.2

Are Principal Investigators and Other Investigators required for the contract?

The Government is not requiring Principal Investigators and Other Investigators. Please see response to question above and below. Also see RFP Attachment 6.

Ref RFP, Section L:Instructions to Offerors.b.1.b.4

The RFP states that resumes of all key personnel are required. Can the Government verify the key positions are the Program Manager and Project Manager?

As stated above - Program Manager and Project Manager are considered Key Personnel. It is up to the Offeror to designate any other Key Personnel. Also See RFP Attachment 6.

23 Ref RFP, Section L:Pages 51-76; RFP- Additional Technical Proposal Instruction:Page 103;

RFP-Section M:Page 77.

There exist a number of inconsistencies between the two instruction sections and Section M, including proposal structure and delivery method (paper or electronic). Can the Government deconflict these three sections?

The proposals need to submitted/delivered electronically through NIH eCPS System in accordance with RFP Attachment 1- Packaging and Delivery of Proposals. The offerors are not required to submit hard copy/paper proposals.

Please reference RFP Section L, Attachment 1, Attachment 6, and Attachment 14. Section M of the RFP pertains to Evaluation of Proposals.

24 Ref All of Us Research Data Browser hyper link, Section 4: Page 11

What is the Source (i.e., HL7 or another organization) of the Broad Categories of the Research Data Hub?

Source documentation is the clinical research trial documentation produced by the clinical research team conducting the trial. It is entered into the electronic medical record.

25 Can I know who is the incumbent ? The incumbent is Agile Decision Sciences, LLC

RFP

Reference

Section Number Question/Clarification Government Response

26 Personnel X, 78 Please clarify if the offeror must provide both a Principle Investigator (page x) and a Program Manager (p. 78)?

The Government provided an estimated level of effort for the base and term options in Attachment 14, however the proposed labor categories and LOE may be different based on the offerors unique technical approach. As stated in Attachment 6 Program Manager will be designated as Key personnel and Program Manager in context of this requirement is the same as the PI/PD.

27 SOW Attachment 3, pg. 2 Please provide information on the tools available to support the required data extractions from the source systems.

Labloader for internal labs.

Data managers for abstraction of other data from source documentation.

28 SOW Attachment 3, pg. 2 Please clarify if the offeror should propose tools for this purpose or if the offeror must use existing tool sets.

The contractor must use existing tools.

29 SOW Attachment 3, pg. 2 Please provide information on the tools available to support the creation of adhoc reports.

Tools exist for creating ad hoc reports that the contractor will use such as Jreview

30 SOW Attachment 3, pg. 2 Please clarify if the offeror should propose tools to support ad hoc reporting or if the offeror must use existing tool sets.

The contractor must use existing tools

31 SOW Attachment 3, pg. 2 Level I and Level II quality checks – please provide information on the tools available to support quality checks, data validation activities, etc.

Database validations, database reports and manual checks

32 SOW Attachment 3, pg. 2 Please clarify if the offeror should propose tools to support data quality or if the offeror must use existing tool sets.

The offerors should not submit/propose tools to support data quality. This RFP is not for contracting for tools.

33 SOW Attachment 3, pg. 2 Please clarify if a data catalog or data governance technologies are in use today.

A data catalog and data governance technologies are in place today

RFP

Reference

Section Number Question/Clarification Government Response

34 SOW Attachment 3, pg. 2 Please clarify if the offeror may propose technologies to support the creation of a data catalog?

The requirement is not for technologies to support the creation of a data catalog.

35 SOW Attachment 3, pg. 2 Please clarify if the offeror may propose data governance technologies?

The requirement is not for data governance technologies.

36 SOW Attachment 3, pg. 3 The RFP states the offeror must develop Standard Operating Procedures to support quality measures – please clarify if the offeror will be required to create all new SOPs or if there are existing SOPs that must be maintained and updated over time.

The offeror will be required to create all the new SOPs.

The offerors are advised to read the Statement of Work carefully to develop a comprehensive response.

37 SOW Attachment 3, pg. 3 For the requirement for multi- Institute Study Data Management please clarify what database tools are used and if databases are hosted in the cloud or on premise.

The CCR clinical research databases are used to support the multi-institute studies. The hosting questions are not applicable to this work.

38 SOW Attachment 3, pg. 4, Additional Business Proposal Instructions,

pg. 1

Do the training assumptions provided for annual CIBMTR meetings represent all training session requirements? If no, please provide an estimate of the number of training sessions required each year.

Attachment 14 Additional Business Proposal Instructions include the assumptions for the CIBMTR training. Offerors should refer to Section 4.2 and

4.2.1. of the SOW for training requirements associated with the training of their own staff in order to meet the requirements of the SOW.

39 SOW Attachment 3, pg. 4, Additional Business Proposal Instructions,

pg. 1

Please clarify whether training sessions are remote, in person, or a combination of both modes.

Training sessions are anticipated to be remote/virtual.

40 SOW Attachment 3, pg. 4, Additional Business Proposal Instructions,

pg. 1

Please clarify if the offeror is responsible for including training facility costs in the proposal.

Please see response to the question above. The Government does not anticipate any training facility costs will be required. As stated in RFP Attachments 6 and 14, the offerors need to prepare their proposal based on

RFP

Reference

Section Number Question/Clarification Government Response their approach to meet the requirements of the SOW.

41 Government Furnished Property

Attachment 4, pg. 2 Please confirm the offeror is not expected to maintain or provide support for the Government Furnished Property listed in Attachment 4.

Please see RFP Article G.6.

42 Travel Attachment 10, pg. 1 Please provide an estimated number of trips annually to support the contractual requirements.

RFP Attachment 10 is a template/format for preparing the cost proposal.

The Government's cost assumptions were provided in Attachment 14. As stated in Attachment 14, Offerors are advised to give careful consideration to the Statement of Work, all reference material provided as attachments, the technical evaluation criteria, and the RFP as a whole, in the development of your proposal.

43 Is there an incumbent on this contract? If so, please provide the incumbent details like name, current contract number, duration and are they eligible to bid?

Agile Decision Sciences, LLC, Contract Number #75N91020C00004, Period of Performance: 01/15/2020

- 01/14/2023. Incumbent eligibility information is not relevant for the purposes of other offerors submitting a proposal in response to the

RFP.

44 Will the agency let us know its existing infrastructure?

Please refer to the SOW.

45 What is tentative award date/start date? Also how many days are given to recruit around 70 resources for this contract?

The start date is 1/15/2023 and the Government anticipates a 2 week transition-in. Please see the RFP and the SOW.

(END OF QUESTIONS AND ANSWERS)

II. REVISIONS TO SECTIONS OF THE RFP

a. ARTICLE C.2. REPORTING REQUIREMENTS, paragraph b. subparagraph A. (pg. 10 of the RFP) titled POSTION SENSITIVITY DESGINATIONS is deleted in its entirety and replaced with the following to reflect that Tier 2S investigations are not applicable to this requirement:

A. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). To determine the designation, the Position Designation Tool (PDT) discussion is found at:

https://www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx and the link to access the tool is found at: https://pdt.nbis.mil/ The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Tier 5: Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and "Q" access eligibility.

[ ] Tier 5SR: Reinvestigation.

[ ] Tier 4: High Risk Public Trust (HRPT).

[ ] Tier 4SR: Reinvestigation.

[ ] Tier 3: Non-Critical Sensitive, National Security, including Secret and "L" access eligibility.

[ ] Tier 3SR: Reinvestigation.

[ ] Tier 2S with Subject Interview: Moderate Risk Public Trust (MRPT).

[ ] Tier 2SR: Reinvestigation.

[X] Tier 1: Low Risk, Non-Sensitive, including HSPD-12 Credentialing.

b. ARTICLE H.9.1. INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY, paragraph 5.

(pg. 28 of the RFP) titled Position Sensitivity Designations is deleted in its entirety and replaced with the following to reflect that Tier 2S investigations are not applicable to this requirement:

5. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). To determine the designation, the Position Designation Tool (PDT) discussion is found at:

https://www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx and the link to access the tool is found at: https://pdt.nbis.mil/ The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Tier 5: Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and "Q" access eligibility.

[ ] Tier 5SR: Reinvestigation.

[ ] Tier 4: High Risk Public Trust (HRPT).

[ ] Tier 4SR: Reinvestigation.

[ ] Tier 3: Non-Critical Sensitive, National Security, including Secret and "L" access eligibility.

https://www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx https://www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx https://pdt.nbis.mil/ https://www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx https://www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx https://pdt.nbis.mil/

[ ] Tier 3SR: Reinvestigation.

[ ] Tier 2S with Subject Interview: Moderate Risk Public Trust (MRPT).

[ ] Tier 2SR: Reinvestigation.

[X] Tier 1: Low Risk, Non-Sensitive, including HSPD-12 Credentialing.

c. SECTION J – LIST OF ATTACHMENTS: The following RFP attachments are updated with this

Amendment:

i. Attachment 1: Package and Delivery of Proposal (Non R&D)

ii. Attachment 6: Additional Technical Proposal Instructions

iii. Attachment 14: Location of Attachment 14 is deleted in its entirety and replaced with the following: Please see Attachment 14 at the end of the RFP.

Attachment 1

Revised 10/14/2022

Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation.

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

Attachment 1

Revised 10/14/2022

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one-inch on all sides.

7. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed 35 pages.

2. Total page count does not include:

a. Title and Back Page; Government Notice for Handling of Proposals; Table of Contents; Section Dividers that do not contain information other than title of Section; certificates and licensures; SOPs; Summary of Related Activities;

letters of commitment from subcontractors and consultants

b. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

3. Each Resume/Curriculum Vitae (CV) shall not count towards page limitation and shall not exceed three ( 3) pages.

4. Pages exceeding limitations will be removed from the proposal and will not be considered.

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

RFP 75N91022R00023

Attachment 6, revised 10/14/2022

The following Additional Technical Proposal Instructions reflect the requirements of the Request for Proposal (RFP) and are meant to provide additional instructions as well as a uniform format for the technical proposal. The information requested in these instructions should be used as a guide for formatting and preparing the proposal. The Offeror is advised to give careful consideration to the Statement of Work (SOW), all reference material, and attachments, the technical evaluation criteria, and the RFP as a whole, in the development of their Technical Proposal.

If the Offeror proposes subcontracts to perform portions of the Statement of Work, it should clearly identify the specific sections for which they plan to utilize subcontractors, as well as the method and level of integration between the prime and subcontractor(s), and the expected advantages of such an approach.

The Government encourages the offerors to be complete but succinct in the presentation and to limit the total number of pages for the entire proposal to 35 pages.

The outline/order of these instructions may be inconsistent with Technical Discussion Section of the RFP, but the outline/order of the proposal shall be in accordance with these instructions rather than the section entitled “Technical Discussions’ in the RFP.

TOTAL PAGE COUNT DOES NOT INCLUDE (some of which may be added as appendices): Title and Back Page; Government Notice for Handling Proposals; Cover Letter; Table of Contents;

Section Dividers that do not contain information other than title of Section; Resumes/CVs;

certificates and licensures, Standard Operating Procedures (SOP), Summary of Related Activities, letters of commitment from proposed consultants and subcontractors.

FORMATTING AND LAYOUT:

Use your usual word processing and spreadsheet programs to prepare and format the technical and business proposals. For excel files, please ensure everything is formula based and that there are no references to outside files. Offerors must refer to the solicitation Attachment entitled “Packaging and Delivery of the Proposal,” which details strict guidelines, including page limitations, formatting and layout of proposals, and prohibits the offerors use of links to internet web site addresses (URLs) to direct readers to alternate sources of information.

TECHNICAL PROPOSAL – TABLE OF CONTENTS

General Instructions

The offeror’s proposal (e.g., Word, PDF, or other files) should demonstrate conformance with Section 508 as instructed at Create Accessible Digital Products and HHS Accessibility Resources.

(See Create Accessible Digital Products | Section508.gov and Accessibility Resources | HHS.gov) https://www.section508.gov/create/ https://www.hhs.gov/web/section-508/additional-resources/index.html

SECTION 1:

A. PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, UEI number, proposal part, and authorized personnel. The authorized personnel shall include the name, title, address, e-mail and phone number of the Project Manager and the company representative(s) who are authorized to negotiate on behalf of the Offeror and who can obligate the Offeror.

B. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

C. TECHNICAL PROPOSAL COST SUMMARY

D. TABLE OF CONTENTS

SECTION 2: TECHNICAL DISCUSSIONS

Offerors shall provide a technical proposal that includes the following general areas:

A. Technical Approach

The Offeror should describe how it plans to accomplish the requirements of the Statement of Work in sufficient detail to demonstrate an understanding of the project and to allow the Government to evaluate the Offeror’s technical approach. The approach should demonstrate a clear understanding of the needs of the program and an understanding of the potential problems involved. The Offeror shall identify potential problems that could be encountered in implementing its’ proposed technical approach as well as possible solutions. The Offeror shall identify its internal procedures for monitoring the progress of assigned tasks. As part of this description, explanation shall be provided on the organization of both the administrative and technical team and the degree of responsibility that key team members are expected to be able to exercise. In the event that the Offeror utilizes subcontractors, the Offeror shall describe in detail how it will coordinate with the subcontractor management. Lines of responsibility between the Offeror and any subcontractor must be clearly delineated.

Please assume the following when preparing the section for the Technical Approach:

• Annual Number of protocols: ~400

• Accrual per year: ~5000

Transition-In Plan: The Offeror shall develop and submit a draft Transition-In Plan at the time of proposal submission, which will describe the contractor’s strategy for taking over work from the incumbent contractor, if necessary, to ensure continuity of Clinical Data Management services.

The plan must contain, Offeror’s approach to organizing a seamless transition and maintaining ongoing work, including the transition team, transition of authority, duties, activities. and equipment. The Transition-In plan shall outline potential transition-in related risks and corresponding mitigation measures.

B. Personnel Capability and Experience

Evidence shall be provided demonstrating personnel capability and experience in all data management functions which include, but are not limited to, a standardized approach to data management activities and contract staff training on Good Clinical Data Management Practices

(GCDMP).

Describe the experience and qualifications of Key personnel and the classes of personnel who will be assigned for direct work on this project. Provide a plan that delineates the disposition of personnel to address the requirements of the Statement of Work and the organizational/management structure that will ensure these requirements are met.

All professional personnel who will be considered Key Personnel on the project, including the Contractor Program Manager and Project Manager should be listed. The proposed duties of the Key Personnel on the project shall be described in detail. The level of time commitment of Key Personnel to this project shall be described in the proposal. The resumes of Key Personnel shall be provided and include education, qualifications, experience, and accomplishments. For any Key Personnel positions, for which the person is not currently employed by your organization, provide a letter of commitment or other evidence of commitment to the project.

It is estimated that the following roles and responsibilities would be required to perform the contract:

(1) Program Manager

The Program Manager shall have at a minimum, a MS degree related to bioscience, and 10 years of a proven successful track record in leading data management projects/programs of similar size and scope for both the Government and pharmaceutical sponsors.

It is preferable that this experience encompasses clinical research in oncology and early phases (Phase I and Phase II) clinical trials. It is also preferable the Program Manager has an advanced medical degree (such as a Registered Nurse or Doctor of Medicine) and a scientific and clinical experience background. The Program Manager shall have primary responsibility on behalf of the Contractor for the execution of tasks delineated in the Statement of Work, all administrative and supervisory activities, and be able to analyze and produce documents regarding the quality and productivity of the activities.

(2) Project Manager

The Project Manager shall have documented experience managing large data management projects, as well as GCDMP. The Project Manager, at a minimum, shall have 5 years of documented successful experience of providing oversight of daily operations of data management staff and first-level supervisors/team leads, and serving as a point of contact with Government and sponsor project managers, clinical research teams, and protocol coordinators. The Project Manager must have experience and skills in effective resource management, monitoring data quality, performing analysis and documentation of data error trends, identifying and implementing measures for data quality and work efficiency improvement.

The Project Manager’s primary responsibility shall include oversight of daily operations of all data management staff, including Team Leads, and serving as a point of contact with CCR personnel, clinical research teams, and protocol coordinators.

(3) Other Project Personnel:

a. Team Leaders

The Team Leads shall have documented experience in the requirements of clinical data management and be responsible for managing the quality of data produced by the project staff in terms of data completeness, data integrity, accuracy, and consistency with source documents. Team Leads shall have documented knowledge and experience in data management of clinical/biomedical research, understanding of quality assurance, data reporting, and maintaining patient’s data confidentiality/privacy in clinical data management. The Team Leads shall provide oversight of data managers. The Team Leads may serve as the primary interface with the NCI’s Bioinformatics Group to relay the data management needs or requirements for the databases this staff will utilize. Such systems include the clinical research databases, Oracle Clinical database, RAVE and all future information systems adopted. It is expected that the Team Leads will contribute to the analysis and documentation regarding data quality and productivity of the data management activities as well as proactively work with the Project Manager on developing and implementing data management solutions in order to stay current with the clinical research data requirements and needs.

b. Data Managers

The Data Managers shall have primary responsibility to abstract, enter, and report data, perform Level I self-quality checks and Level II peer quality checks per SOPS.

Prepare data for submissions, site monitoring visits and audits, address data queries timely and accurately, perform user acceptance testing of electronic case report forms (eCRFs), and coordinate data management activities with the NCI CCR clinical teams.

The Data Manager workload is driven by protocol patient accrual rate, the level of protocol complexity, and the reporting requirements. Historically, there have been 500 open clinical trials and approximately 55 new protocols a year, which comes out to approximately 150-200 site monitoring visits per year, which are performed under a separate contract. However, these numbers can fluctuate within a year and year to year.

c. Additional Personnel

Document the availability of other professional or appropriate support personnel necessary to carry out the daily operation of the tasks delineated in the Statement of Work. List names, titles, and proposed duties of additional personnel, and if any will be required on a subcontract or consulting arrangement.

C. Corporate Capabilities

Corporate Capabilities are defined as your organization’s experience with accomplishment of work, either past or ongoing which is comparable or related to the effort required by this solicitation. This includes overall Offeror or corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work.

1. The offeror should describe in detail prior and current experience of the organization in furnishing services similar to each area described in the Statement of Work. The proposal should include sufficient information to demonstrate the previous effectiveness of the firm in similar or related work. Include documentation with specific reference(s) to applicable contract number(s), date(s) of agreement(s) and dollar volume. This documentation should include clear and concise description of these project(s) and should indicate the project sponsor (e.g., pharmaceutical company, government contract or grant, etc.). For each of the described projects, references (including contact information) should be provided. The Offeror should also reference any relevant corporate experience that demonstrates the ability to work collaboratively with other stakeholders to meet a project’s mission and goals.

2. Describe the relationship of the proposed working group within the offeror’s organizational structure as well as how this relationship may facilitate collaboration within the organization in performance of this project. Information should be provided on how the organization will prioritize and support the Program Manager and/or Project Manager in resolving problems or special situations.

3. Describe fully the proposing organization’s recruitment and retention processes and practices. Provide employee retention rates for the past three (3) years.