REQUEST FOR PROPOSAL (RFP) · PDF fileREQUEST FOR PROPOSAL (RFP) ... SENT BY OVERNIGHT OR EXPRESS COURIER, ... The Contractor will use capture and management electronic data ;

CONRAD Eastern Virginia Medical School

RFP No. C-16-103

REQUEST FOR PROPOSAL (RFP)

CONRAD RFP # C-16-103

CONRAD/EVMS April 25, 2016

Prepared by: Programs Group


RFP No. C-16-103

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REQUEST FOR PROPOSAL (RFP) RFP Number:

C-16-103

Issue Date:

2 May 2016

CONRAD Project Title:

Master Service Agreement - Data Management and Statistical Analysis for CONRAD/EVMS Clinical Research

CONRAD Group Issuing RFP:

Clinical Group CONRAD/EVMS 1911 North Fort Myer Drive Suite 900 Arlington, VA 22209

Location Where Work Will Be Performed:

Contractor’s Offices

Anticipated Date of Master Service Agreement:

7/1/2016 – 6/30/2019 (With the possibility of two (2) one year renewable options.)

RFP Closing Date (Sealed Bids will be Received Until):

27 May 2016, 5:00 pm EST

Sealed Proposals Will Be Opened On:

31 May 2016

Additional RFP Information:

Addenda to this RFP will be posted on the following EVMS website: http://www.evms.edu/about_evms/administrative_offices/materials_management/solicitations/

http://www.evms.edu/about_evms/administrative_offices/materials_management/solicitations/



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This link is also available under the “Contracting Opportunities” section located on http://www.conrad.org/working.html. Please direct all inquiries for information about this RFP should be sent in writing to the following: Dr. Kumar Reddy Research Contract Specialist CONRAD Programs Group [email protected] To ensure that responses to RFP questions are available to all responsible bidders (“Offerors”), CONRAD/EVMS will post all questions and responses on: https://www.evms.edu/about_evms/administrative_offices/materials_management/solicitations/ However, it is the sole responsibility of the Offeror(s) to periodically check the before mentioned website for any response(s) to RFP question(s). In addition, once the RFP has closed, Offeror(s) shall not contact CONRAD or other EVMS staff directly to ask about the RFP. This restriction on Offeror communication with CONRAD or other EVMS staff is to ensure fairness in the competitive process.

Due Date for RFP Questions:

27 May 2016 by 5:00 pm EST

RFP Time Extensions:

Requests for additional RFP information and the associated responses shall not extend the due date for bids in response to this RFP. To ensure fairness in the competition process and that all Offerors are given the same amount of time to respond to the RFP, CONRAD reserves the right, at CONRAD’s sole discretion, to extend the time for responses to this RFP to all Offerors, as deemed appropriate; and under no circumstances shall separate or individual extensions be granted. CONRD/EVMS will post all RFP extensions on the following website: https://www.evms.edu/about_evms/administrative_offices/materials_management/solicitations/.

http://www.conrad.org/working.html

mailto:[email protected]

https://www.evms.edu/about_evms/administrative_offices/materials_management/solicitations/





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PROPOSALS MAY BE MAILED, SENT BY OVERNIGHT OR EXPRESS COURIER, HAND-DELIVERED OR SENT ELECTRONICALLY TO THE FOLLOWING: Mail, Overnight or Express Courier or Hand-Delivery to: CONRAD/EVMS Attn: RFP No - C-16-103 1911 North Fort Myer Drive Suite 900 Arlington, VA 22209

E-Mail Delivery: [email protected] Subject: RFP No - C-16-103 (This e-mail address is for RFP delivery only. An email confirmation will be forwarded and should be retained for future reference.) Disclaimer: Electronic submissions may be subject to delay due to power and, or network failure, power outage, rate control parameters, spam filters, etc. All electronic submissions are subject to the actual receipt date and time according to CONRAD’s email inbox.



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TABLE OF CONTENTS PAGE 1.0 Purpose 5

2.0 Background 5

3.0 Statement of Needs 5

4.0 Method of Payment 8

5.0 Invoices, Reporting and Delivery Instructions 8

6.0 Pre-proposal Conference (Omitted) 9 7.0 Proposal Preparation and Submission Instructions 9

8.0 Evaluation, Negotiation and Award Criteria 13 9.0 Contract Negotiations 14

10.0 Award 16 11.0 Attachments

• Attachment A - RFP Coversheet 18

• Attachment B - Offeror RFP Certification 19

• Attachment C - Entity Data Sheet 20

• Attachment D – Sample Study - Parameters

• Attachment E - Pricing • Attachment F - W9/ W8 Instruction Sheet

22 24 27


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1.0 PURPOSE: The purpose of this RFP is to establish a Master Services Agreement (“MSA”) for the provision of services relating to data management and statistical analysis carried out by or on behalf of CONRAD/EVMS Clinical Research. Approximately four Phase 1 or Phase 2 studies are anticipated. The MSA period of performance is 1 July 2016 through 30 June 2019, with the possibility of two (2), one year renewable options. MSA is for services as needed and there is no firm commitment upon award of this contract.

This RFP is in accordance with the policies of Eastern Virginia Medical School. It provides information to responsible bidders (referred throughout this RFP as “Offeror(s)” and/or “Contractor(s).”) in order to solicit competitive proposals (“Proposals”).

2.0 BACKGROUND:

This Master Service Agreement is for CONRAD, located in Arlington, Virginia, a division within the Department of Obstetrics and Gynecology at Eastern Virginia Medical School located in Norfolk, Virginia (hereinafter referred to as “EVMS” or “CONRAD” and, collectively, as “CONRAD/EVMS”). Through its Sub-Tier Management Program, CONRAD develops safe and affordable products and methods to provide reproductive health, contraception and/or the prevention of the sexual transmission of HIV/AIDS and other infections with particular emphasis on modalities that are appropriate in low-resource settings. CONRAD receives prime award funding from the Federal Government, private foundations and other nonprofit organizations and the contracts and subagreements under its Sub-Tier Management Program contain applicable requirements and standard provision language, which flow-down from these prime awards.

3.0 STATEMENT OF NEEDS*:

*Note: - For the purpose of this Master Service Agreement, “Statement of Needs” will represent any

projects/protocols that fall under the life of this Master Service Agreement. It is anticipated that this Agreement will cover four Phase 1 or Phase 2 studies.

- Parameters for a sample study (Attachment D) have been provided to facilitate proposal costing

(Attachment E).

A. Project Management

The Contractor will provide a project manager to coordinate the provision of Contractor’s services and liaise with CONRAD. Project management will be ongoing throughout the life of the project.

B. Data Management

1. The Contractor will use an electronic data capture and management system.


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System should support:

a) Customized electronic Case Report Forms (eCRFs) based on the protocols;

b) Planning and workflow design;

c) System architecture;

d) Site hosting;

e) Maintenance;

f) Data modification system;

g) Query management system;

h) Audit trail; and,

i) Standard, custom and ad hoc reporting.

2. The data management process will focus on the end goal of achieving a clean

database for statistical analysis. Contractor will design the web-based data collection and management system to include:

a) Database to incorporate clinical and laboratory data;

b) Unique data and repeating data entry screens;

c) Configured edit and logic checks;

d) Electronic signature;

e) Technical site qualification: reviewing PC and Network configurations

(does not include costs of any required new PC or Network configurations);

f) Fully test all eCRF functions, including, but not limited to, data entry,

edit checks, query and electronic signature;

g) Train the CONRAD project monitors and study personnel to use the system;

h) Provide eCRF completion instructions;

i) Maintain a help desk for the duration of the study, including a twenty-

four hours/ five days a week (24/5) technical hotline for system issues; and,


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j) Database validation and User Acceptance Testing.

3. An assigned Data Manager, or equivalent, will:

a) Develop and finalize the Data Management Plan (DMP); b) Annotate the eCRFs; c) Create edit check specifications; d) Track participant status and metrics; e) Verify and clean eCRF data, based on the DMP; f) Lock the database after completion of the data management process, and

after all edit check resolutions and queries are resolved; g) Transfer final locked database to CONRAD; and, prepare PDF archive

files for CONRAD one set per site containing that site’s data and one CONRAD copy containing all trial data” and “Issue archival PDF CDs/DVDs to CONRAD”

4. The Contractor will code Adverse Events and Concomitant Medications using Medical Dictionary for Regulatory Activities (MedDRA), and provide coding reports.

C. Biostatistics

1. The Contractor will create any required randomization schedules and the Statistical

Analysis Plan (SAP) with input from CONRAD. For the final analysis, the Contractor will prepare statistical packages for inclusion in the Clinical Study Report (CSR). The statistician will review all results prior to sending the package to CONRAD. The statistical package will include derived datasets, tables, data listings, figures, and a description of any statistical methods that differ from those described in the SAP. Periodic reports on an as needed basis will be generated for required reporting to funders and to the United States Food and Drug Administration (USFDA). May include:

a) Write Statistical Analysis Plan (SAP), including shells

b) Produce final Tables, Listings, & Figures

c) Provide final data transfer as datasets

d) Provide final programs, formats, catalogues, etc.

D. Medical Writing


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The Contractor will prepare the CSR using an “International Conference on Harmonisation” (ICH) “E3” compliant template. A complete draft will be provided to CONRAD for review prior to finalization. Final documents will be provided to CONRAD for electronic review and approval.

E. Publishing The Contractor will be responsible for all components of the report (i.e., report, tables, listing and figures, appendices, etc.) as defined in the ICH E3 and will deliver all components to a PDF format.

4.0 METHOD OF PAYMENT:

A. US Entities.

The Contactor will be paid by check based on invoices submitted to CONRAD. The contractor shall submit invoices with payment due net thirty (30) days. Submit invoices to the following address:

CONRAD Director of Finance Eastern Virginia Medical School 601 Colley Avenue Norfolk, VA 23507

B. Entities Outside of the United States.

The Contractor will be paid by wire transfer. Wiring instructions should be forwarded to the following:

CONRAD Director of Finance Eastern Virginia Medical School 601 Colley Avenue Norfolk, VA 23507

5.0 INVOICES AND REPORTING:

The Contractor shall prepare and submit invoices and reports to CONRAD according to the following schedule:

Invoice or Report Due Date 1. Invoices

Monthly

2. Final Technical Report & Final Invoice

Forty-five (45) Days after Scope of Work completion and acceptance by CONRAD or after


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expiration or Termination of the Contract.

6.0 PRE-PROPOSAL CONFERENCE (Optional):

Omitted. 7.0 PROPOSAL PREPARATION AND SUBMISSION INSTRUCTIONS:

A. General Instructions.

Delivery of the Proposal must be by one of the following methods: Mail, Overnight or Express Courier or Hand-Delivery to: CONRAD/EVMS Attn: RFP No - C-16-103 1911 North Fort Myer Drive Suite 900 Arlington, VA 22209

E-Mail Delivery: [email protected] Subject: RFP No - C-16-103 (This e-mail address is for RFP delivery only. An email confirmation will be forwarded and should be retained for future reference.) Disclaimer: Electronic submissions may be subject to delay due to power and, or network failure, power outage, rate control parameters, spam filters, etc. All electronic submissions are subject to the actual receipt date and time according to CONRAD’s email inbox.

C. RFP Submission

1. Complete Submissions

Except as provided for under the Proposal Preparation Section, 7.0 (B)(2)(b)(4), which addresses the circumstances under which the submission of missing Proposal information would be acceptable, Offerors must submit a complete response to this RFP in order to be considered for selection under this RFP.

2. Delivery

a. By Mail, Overnight or Express Courier or Hand Delivery

If Proposals are delivered by mail, overnight or express courier or hand-delivery, Offerors must provide one (1) original and four (4) copies of each Proposal submitted to CONRAD for consideration. Each copy



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must include an executed Offeror RFP Certification (Section 11, Attachment B).

b. Delivery by E-Mail

If Proposals are delivered by e-mail, Offerors must properly attach to the email one (1) PDF copy of the RFP response with the executed Offeror RFP Certification (Section 11, Attachment B) in a PDF format and keep a copy of the email confirmation for the Offeror’s records.

Disclaimer: Electronic submissions may be subject to delay due to power and/or, network failure, power outage, rate control parameters, spam filters, etc. All electronic submissions are subject to the actual receipt date and time according to CONRAD’s email inbox.

3. Proposal Acceptance Period

All Proposals must be received by the Due Date and time found on page 1 of this RFP (the “RFP Closing Date”). Proposals received after RFP Closing Date will not be considered. RFP modifications, unless requested by CONRAD and posted to all Offerors on the EVMS RFPs website, will not be considered.

4. Proposal Withdrawals

At the sole discretion of the Offeror(s), Proposals may be withdrawn at any time prior to the RFP Closing Date. After RFP Closing date, letters to withdraw a Proposal will not be accepted and Proposals will remain valid until an award is made and a contract is executed or the RFP is canceled. If an award is not made within one hundred and twenty (120) days from the RFP closure date, the Proposal may be withdrawn at the written request of the Offeror.

C. Proposal Preparation

1. Proposals shall be signed by an authorized representative of the Offeror (Section

11, Attachment B). All information requested should be submitted to ensure consideration as a responsive bidder. Failure to submit all information requested may result in the following:

a. CONRAD may reject the Proposal as unresponsive. Proposals, which

are substantially incomplete or lack key information, may be rejected by CONRAD; or,

b. CONRAD may lower the overall evaluation score due to missing

information; or,

c. CONRAD may require prompt submission of missing information within a prescribed time-period and/or the Offeror may receive a lower overall evaluation score. If after being given an opportunity to submit missing


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information, the Offeror does not provide all of the requested information then subsections 7.0 B (2)(b)(1) and (2) above apply.

2. All information above must be submitted along with the RFP cover sheet

(Section 11, Attachment A) and an Entity Data Sheet (Section 11, Attachment C). Failure to submit all information requested may result in CONRAD requiring prompt submission of missing information and/or giving a lowered evaluation of the Proposal. CONRAD may reject Proposals, which are substantially incomplete or lack key information.

3. Proposals should be prepared simply and economically, providing a

straightforward, concise description of capabilities to satisfy the requirements of the RFP. Emphasis should be placed on completeness and clarity of content and include or address the following:

a. Organization - Proposals should be organized in the order in which the

requirements are presented in the RFP;

b. Pagination - All pages of the Proposal should be numbered;

c. Paragraph Structure - Each paragraph in the Proposal should reference the paragraph number of the corresponding section of the RFP and cite the paragraph number, sub letter, and repeat the text of the requirement as it appears in the RFP. If a response covers more than one page, the paragraph number and sub letter should be repeated at the top of the next page;

d. Table of Contents - The Proposal should contain a table of contents,

which cross-references the RFP requirements; and,

e. Additional Information - Information which the Offeror desires to present that does not fall within any of the requirements of the RFP should be inserted at an appropriate place or be attached at the end of the Proposal and designated as additional material.

Incomplete Proposals or Proposals, which, lack clarity of contact and organization submitted to CONRAD/EVMS submitted under this RFP may risk a reduced evaluation score or elimination from consideration.

4. As used in this RFP, the terms “must”, “shall”, “should” and “may” identify the

critical requirements. “Must” and “shall” identify requirements where absence will have a major negative impact on the suitability of the Project and/or mandatory requirements, which are required by law or regulation and as such they cannot be waived and are not subject to negotiation. This includes any applicable prime award funding flow-down provisions, which are mandatory and/or required as applicable. The USAID Standard Provisions are an example of mandatory terms and conditions that are not subject to negotiation. Items labeled as “should” or “may” are highly desirable, although their absence will not have a large impact on the Project and would be useful, but are not absolutely


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necessary or required. The inability of an Offeror to satisfy a “must” or “shall” requirement does not automatically remove that Offeror from consideration; however, it may seriously affect the overall rating of the Offerors’ Proposal.

5. Each copy of the submitted Proposal should be contained in a single volume

where practical (i.e., binder, stapled, or otherwise secured so that the pages will not easily separate or come loose). All documentation submitted with the Proposal should be contained in that single volume. For electronic submissions, the Proposal should be contained in a single PDF and submitted in one e-mail transmission. Please report technical issues with electronic deliveries immediately to [email protected].

6. All expenses involved with the preparation and submission of Proposals to

CONRAD, or any work performed in connection therewith, shall be borne by the Offeror. No payment(s) will be made for any responses received; or, for any other effort required of or made by the Offeror(s) prior to commencement of work as defined by a fully executed contract.

7. Ownership of all data, materials, and documentation originated and prepared for

CONRAD pursuant to the RFP shall belong exclusively to CONRAD and may be subject to public inspection in accordance with the Virginia Freedom of Information Act (FOIA) unless a confidentiality of non-disclosure agreement is signed by the parties and the release of records would, at the sole discretion of EVMS, adversely affect the bargaining position of CONRAD/EVMS.

D. Oral Presentation

Offerors who submit a Proposal in response to this RFP may be invited or required to give an oral presentation of such Proposal to CONRAD. This provides an opportunity for the Offeror to clarify or elaborate on the Proposal. This is a fact finding and explanation session only and does not include negotiation. If such oral presentations are deemed appropriate at the sole discretion of CONRAD, CONRAD will schedule the time and location for such presentations. Oral presentations, including via telephone, video/internet conferencing are available at the sole discretion of CONRAD and may or may not be conducted.

E. Specific Proposal Instructions

1. Proposals should be as thorough and detailed as possible so CONRAD may

properly evaluate the Offeror’s capabilities to provide the required goods/services. Offerors are required to submit the following items as a complete Proposal:

a. Return the RFP cover sheet and all addenda, if any, signed and filled out

as required;

b. Completed Entity Data Sheet attached to the RFP, and other specific items or data requested in the RFP;


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c. A written narrative statement to include:

i. Experience in providing the goods/services described herein;

ii. Names, qualifications and experience of key personnel to be assigned to the project; and,

iii. Resumes of key personnel to be assigned to the project;

2. Specific plans for providing the proposed goods/services, such as:

a. List of proposed equipment/goods/etc. including operating parameters,

illustrations, database system, etc.

b. What, when and how the service will be performed and reference to any detailed workplans, milestones and timelines; and,

3. Costing Template, per Attachment E

4. Internal Revenue Service (IRS) form W-9 for entities based in the United States

(US) and appropriate W-8 for non-US based entities, signed by the Contractor’s authorized official (See Section 11, Attachment D for W9/W8 Instructions).

8.0 PROPOSAL EVALUATION:

A. Evaluation Criteria

Award of the Contract under this RFP shall be based on a written evaluation of the RFP evaluation criteria below (i.e., score sheet) of each responsible Offeror. Note that failure to provide accurate information required by this RFP may result in a lower score or rejection of the Proposal. CONRAD has broad flexibility in fashioning the details of competition for this RFP. This may include conducting on-line Reverse Auctions for certain products within this RFP or setting price targets as part of follow-on negotiations in order to determine the prices that will be used to evaluate the pricing part of your Proposal.

A two-stage procedure will be utilized in evaluating the proposals, with technical evaluation of the proposal being completed prior to any focus on or comparison of price or other criteria.

Technical Evaluation Point Value 1. Qualifications and experience of Offerors

in providing the services and may include references from other clients/ experience, including, but not limited to, skill level of company representatives assigned to this project.

25


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2. Specific plans or methodology to be used to perform the services.

35

3. Quality of responses to the RFP, including,

but not limited to, comments and suggestions, service support and training offered.

Financial and Other Criteria Evaluation

10

1. Price

20

2. Small, Women, and Minority Vendors (SWaM)

10

Total: 100

9.0 CONTRACT NEGOTIATION:

A. Based on evaluation of the Proposals, one or more successful Offerors will be selected. Award of the contract shall be made to the Offeror(s) deemed to be fully qualified and best suited for the Project based on the evaluation criteria set forth herein. CONRAD/EVMS will select the Proposal determined during the evaluation of the timely submitted Proposals to be the most advantageous in meeting the specifications as outlined under this RFP. This may or may not be the Offeror, which presented the lowest costs/price.

B. CONRAD will forward the successful Offeror(s) a draft contract for review and

negotiation. During this negotiation process, the successful bidder may review the terms and conditions and negotiate with CONRAD/EVMS on acceptable contract language.

C. Terms and Conditions including, but not limited to, insurance, governing law, intellectual

property and data rights and dispute resolution that are added to or modified from CONRAD/EVMS approved terms and conditions shall require CONRAD/EVMS approval.

D. Non-Negotiable Terms and Conditions.

By submitting a response to this RFP the Offeror agrees that it, and any subcontractors that Offeror shall utilize to fulfill the Contract Workscope, shall be subject to mandatory standard provisions that flow-down from the prime award made to CONRAD/EVMS by the Federal Government or private funders applicable to that contract under the prime award and that it must certify compliance with certain federal laws/guidelines, as applicable, including, but not limited to the following:

1. Equal Employment Opportunity (EEO) Clause for Veterans. An offeror or

contractor shall abide by the requirements of 41 CFR 60-300.5(a). This regulation prohibits discrimination against qualified protected veterans, and


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requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans.

2. Equal Employment Opportunity (EEO) Clause for Individuals with

Disabilities. An offeror or contractor shall abide by the requirements of 41 CFR 60-741.5(a). This regulation prohibits discrimination against qualified individuals on the basis of disability, and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified individuals with disabilities.

3. Equal Employment Opportunity (EEO) Clause for Individuals based on Race,

Color, Religion, Sex, or National Origin. An offeror or contractor shall abide by the requirements of 41 CFR 60-1.4(a). This regulation prohibits discrimination against qualified individuals on the basis of race, color, religion, sex, or national origin, and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified individuals without regard to their race, color, religion, sex, or national origin;

4. Copeland “Anti-Kickback” Act (18 U.S.C. 874 and 40 U.S.C. 276c), as

supplemented by Department of Labor regulations (29 CFR part 3, “Contractors and Subcontractors on Public Building or Public Work Financed in Whole or in Part by Loans or Grants from the United States”), prohibiting the Contractor from inducing, by any means, any person employed in the construction, completion, or repair of public work, to give up any part or compensation to which otherwise entitled;

5. Davis-Bacon Act, as amended (40 U.S.C. 276a to a-7) and as supplemented by

Department of Labor regulations (29 CFR part 5, “Labor Standards Provisions applicable to Contracts Governing Federally Financed and Assisted Construction”), regulating wages to laborers and mechanics;

6. Contract Work Hours and Safety Standards Act (40 U.S.C. 327-333) as

supplemented by Department of Labor regulations (29 CFR part 5), regulating laborer and mechanic work hours and safety standards;

7. Rights to Inventions Made Under a Contract or Agreement – (37 CFR part 401,

“Rights to Inventions Made by Nonprofit Organizations and Small Business Firms Under Grants, Contracts and Cooperative Agreements,” providing for the invention rights of the Parties and the Federal Government;

8. Clean Air Act (42 U.S.C. et seq.) and the Federal Water Pollution Control Act

(33 U.S.C 1251 et seq.) as amended related to applicable standards under said regulations; and,

9. Worker’s Compensation Insurance (42 U.S.C. 1651, et seq.) requiring worker’s

compensation insurance for contracts, which require performance outside the United States as applicable per the circumstance of each particular contract.


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E. All CONRAD/EVMS contracts are subject to prime funding constraints and applicable federal and state laws, regulations, guidelines as well as CONRAD/EVMS policies and procedures. If CONRAD and the Offeror(s) are unable to agree on the negotiated contract terms and conditions, CONRAD may elect to terminate negotiations and begin negotiations with the second best ranked Offeror and so forth. If those negotiations do not result in mutually acceptable contract terms and conditions, the negotiations with the next best qualified Offeror(s) will continue until there is an executed contract, there are no more Offerors to negotiate with based on submitted/complete Proposals or CONRAD, at its sole discretion, terminates the RFP. No Offeror shall have any claims and/or rights against CONRAD and/or EVMS arising from such negotiations and/or the RFP evaluation or overall process. Please see also the following RFP sections:

1. 7.0 (C)(4) – Proposal Preparation/ Mandatory Prime Funding Provisions;

2. 9.0 (A) – Contract Negotiation/ Pre-Award Selection Evaluation Criteria; and,

3. 9.0 (E) – Contract Negotiation/ Non-Negotiable Terms and Conditions.

F. At the conclusion of negotiations, the Offeror(s) may be asked to submit in writing, a

Best and Final Offer (BAFO) executed by the authorized representative of the Offeror. The negotiated contract will also be submitted to the Offeror for signature with the understanding that all contracts funded under prime awards to EVMS by the United States Government, private foundations or other nonprofit organizations may be subject to availability of funds. Under these circumstances, there may be additional approval requirements required by the funding federal agency, private foundation or other organization. After submitting the BAFO and/or the Contract is fully executed, no further negotiations shall be conducted with the Offeror(s). In the case of BAFO submission, the Offeror’s Proposal will be rescored to combine and include the information contained in the BAFO. CONRAD/EVMS will base its final decision regarding the contract award on the final evaluation, which will include the BAFO.

G. Cancellation of Contract.

CONRAD/EVMS reserves the right to cancel and terminate any resulting contract, in part or in whole, without penalty, unless otherwise negotiated under the contract, upon thirty (30) days prior written notice to the contractor. Any contract cancellation notice shall not relieve the Offeror of the obligation to deliver and/or perform on all outstanding orders issued prior to the effective date of cancellation.

10.0 AWARD:

A. Upon the announcement of the decision to award under this RFP, the EVMS Department of Materials Management will publicly post such notice in EVMS’ “Vendor Waiting Area” and on the EVMS Internet web site for a minimum of ten (10) days:

http://www.evms.edu/about_evms/administrative_offices/materials_management/solicitations/ .




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CONRAD will contact each successful Offeror with additional post-award information as deemed appropriate per award.

B. While it is the intent of CONRAD/EVMS to award only one contract. CONRAD/EVMS

reserves the right to not make an award or to award multiple contracts, if deemed in the best interest of CONRAD/EVMS or as required under the applicable prime funding award. All decisions made by CONRAD are final. In addition, CONRAD reserves the right, in its sole and absolute discretion, to:

1. Issue a subsequent RFP or not reissue the same RFP if no award is made;

2. Not select any Offeror that submitted a Proposal

3. Make a partial award;

4. Modify, change or reduce the scope of work for this RFP; and/or waive any

irregularities in this RFP or in the Proposals received as a result of this RFP. 11.0 ATTACHMENTS:

{Attachments follow.}


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Attachment A

RFP Coversheet

From:

[Insert Name of Offeror]

Due Date/RFP Closing Date:

27 May 2016

Closing Time:

5:00 pm

Offeror’s Address:

[Insert Offeror’s Street or PO Box Number. If a PO Box is used, please provide a valid corporate office Also, please include city, state, and zip code.]

Offeror’s Contract Manager’s Name:

[Please Insert Name]

CONRAD’s Project Title:

Master Service Agreement - Data Management and Statistical Analysis for CONRAD/EVMS Clinical Studies


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Attachment B

Offeror RFP Certification

RFP Number: C-16-103 RFP Issue Date: 2 May 2016 RFP Closing Date: 27 May 2016, 5:00 pm EST CONRAD

Project Title: Master Service Agreement - Data Management and Statistical Analysis for CONRAD/EVMS Clinical Studies

Name of Entity: [Insert Name] Street Address: [Insert Street Address] State/ Zip Code: [Insert State & Zip Code] FEI/FIN No: [Insert FEI/FIN Number] DUNS No: [Insert DUNS Number] By signing below, I hereby certify that: 1. I have the authority to submit the attached Proposal and am the authorized signatory for the entity

listed above; 2. The terms and conditions of this RFP are accepted by the entity listed above and all good/services

will be provided in accordance with the attached Proposal; and, 3. All information provided in the attached Proposal is true and correct to the best of my knowledge,

information and belief. Signature By: _____________________________________________ Date: ____________

Name: [Insert Printed Name] [Insert Date] Title: [Insert Job Title] Phone: [Insert Phone Number] Fax: [Insert Fax Number] E-mail: [Insert Email Address]


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Attachment C

Entity Data Sheet

Please complete the following information: 1. Entity Name: _________________________________________________

_________________________________________________

_________________________________________________ 2. Signatory Name: _________________________________________________

& Title _________________________________________________

3. Address: _________________________________________________

_________________________________________________

_________________________________________________

_________________________________________________ 4. Primary Negotiation

Point of Contact

Name: _________________________________________________ Title: _________________________________________________ Email Address: _________________________________________________ Telephone Number: _________________________________________________

5. Is the entity registered in System for Award Management (SAM), formerly known as the Central

Contractor Registration (CCR)? Registration in SAM is required under 2 CFR 25 unless the entity is exempt under 2 CFR 25.110.

Yes ______ No ______ Expiration Date: ________________


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6. Entity DUNS Number: __________________________________________________

7. Entity EIN: __________________________________________________ 8. CAGE Number: __________________________________________________ 9. Past Work Experience: (Past work experience in general and as it pertains to the Proposal

submitted in response to an RFP or an RFQ.) 10. Key Personnel: (List Names and Titles and attach resumes). 11. Professional references: (Please limit response to no more than three (3) references. Also, please

include the approximate dates services were performed for each reference.) 12. Small Business Status (Check all that apply): Offeror must be registered with an authorizing

agency, such as the Small Business Administration or Department of Small Business and Supplier Diversity. A copy of the certificate(s) must be provided.

___ Small Disadvantaged Owned Business (SDB) ___ Woman Owned Small Business (WOSB) ___ Veteran Owned Small Business (VOSB) ___ Minority Owned Small Business (MOSB) ___ HubZone Small Business (HSB) ___ Service Disabled Small Business (SDVOSB) ___ Small Business (SB) ___ Not Applicable (NA)


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Attachment D

Sample Study Parameters

A. Overview/Protocol Assumptions:

Protocol Assumptions

Study phase I

Study design Exploratory Pharmacokinetic and Pharmacodynamic Study Indication HIV prevention

Number of participating countries 2 (United States and Dominican Republic)

Number of sites 2

This prospective, randomized study expects to enroll 48 participants across two sites. Participants will be seen at ten (10) visits over a period of approximately three (3) months. Endpoint samples [up to five (5) sample types] will be collected and analyzed at multiple time points during the study.

It is anticipated that the majority of endpoint samples will be batched and analyzed at the end of the study. It is also anticipated that up to two (2) laboratories will be performing endpoint sample analysis, transferring results to Contractor upon completion of analysis.

B. Project Timeline.

Activity / Milestone

Study Start-up (IRB approvals) Month 1

Site Initiation Visits Month 1

First Participant/First Visit Month 2

Last Participant/Last Visit Month 12

Lab Analysis Complete Month 15

Statistical Analysis Complete Month 17

Final Integrated CSR Month 19


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C. Estimated study parameters

Participants Number 48

Meetings

Kick off meeting(s) 1

Investigator meeting(s) 1

In person meeting(s) 0

Teleconference meeting(s) 30

Data Management

Number of Unique eCRF pages 24

Number of eCRF pages / participant 200

Total eCRF pages 10,000

Number of edit checks 220

Number of laboratories 2

Number of database transfers 2

Biostatistics

To include: Statistical Analysis Plan, programming, data listings, statistical tables, final data transfer as datasets.

Medical Writing

Number of Clinical Reports 2 drafts/final 2 drafts; 1 final

Number of SAE Narratives Up to 5


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Attachment E

Please provide cost for each line item below

Task

Personnel Type

Unit

Unit Cost

Comments

Project Management

Project Management

Hour

Project Admin

Hour

Study Meetings

Kick Off Meeting

Hour

Investigator Meeting

Hour

Teleconference

Hour

Interactive Web Response System (IWRS)

IWRS Development, Testing, and Implementation

Hour

IWRS Study Maintenance, Site Support, and DCF Processing

Month

Data Management Data Management Plan

Hour

Edit Check Specifications

Hour

eCRF Design Hour eCRF Completion Guidelines

Hour

Database Build & Validation

Hour

EDC Site Training and User Administration

Hour

Database Maintenance

Hour


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Task

Personnel

Unit

Unit Cost

Comments

Data Management Hour

Data Transfer Setup

Hour

Data Transfers

Hour

Medical Terminology Coding

Hour

EDC Hosting and Licensing

Month

Biostatistics

Statistical Analysis Plan

Hour

Randomization Schedule

Hour

Programming/QC Statistical Tables

Hour

Programming/QC Listings

Hour

Analysis Dataset Programming

Hour

Regulatory Annual Report, including TLFs

Hour

Final Analysis

Hour

Statistical Analysis Management and Oversight

Hour


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Task

Personnel

Unit

Unit Cost

Comments

Medical Writing

Clinical Study Report (2 drafts + 1 final)

Hour

CSR Publishing

Document

CDISC

ADaM Dataset Programming

Hour

SDTM Domain Programming

Hour

TDM Dataset Programming

Hour

Define.xml (ADaM & SDTM)

Hour

Define.pdf (ADaM & SDTM)

Hour

Blankcrf.pdf Hour

SDTM Reviewer's Guide

Hour

ADaM Reviewer's Guide

Hour


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Attachment F

W9/W8 Instruction Sheet

The Internal Revenue Service (IRS) requires verification of taxpayer information when making disbursements to individuals and entities. This is accomplished by either IRS formW9 for United States (US) entities or W8 for foreign entities not based in the US. Please refer to https://IRS.gov for more detailed information regarding which is the appropriate taxpayer information form that must be completed by your organization and returned with your Proposal in response to the RFP. The links below are provided for your convenience but it is the responsibility of your organization to submit the correct form with your request. Please see the below for links to examples of Taxpayer Information Forms: IRS Form - W9 (US) http://www.irs.gov/pub/irs-pdf/fw9.pdf. IRS Form – W8 (Non-US) There are several types of W8 forms that are available. See the following as an example of one type of W8 that is frequently used: http://www.irs.gov/pub/irs-pdf/fw8ben.pdf.

https://irs.gov/

http://www.irs.gov/pub/irs-pdf/fw9.pdf

http://www.irs.gov/pub/irs-pdf/fw8ben.pdf

Documents

REQUEST FOR PROPOSAL (RFP) · PDF fileREQUEST FOR PROPOSAL (RFP) ... SENT BY OVERNIGHT OR EXPRESS COURIER, ... The Contractor will use capture and management electronic data ;