Solicitation document - TBTC Monitoring Original Solicitation.pdf

11. DELIVERY FOR FOB

DESTINATION UNLESS

BLOCK IS MARKED

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

1. REQUISITION NUMBER

PAGE 1 OF

2. CONTRACT NO.

3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER

5. SOLICITATION NUMBER

75D301-20-Q-71779

6. SOLICITATION

ISSUE DATE

06/15/2020

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

Candice L. Simmons

b. TELEPHONE NUMBER (No collect calls)

(770) 488-1432

8. OFFER DUE DATE/

LOCAL TIME

07/15/2020

9. ISSUED BY CODE 8219 10. THIS ACQUISITION IS 12. DISCOUNT TERMS

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

X UNRESTRICTED

SET ASIDE: % FOR

SMALL BUSINESS

SMALL DISADV. BUSINESS

8(A)

SIC: 541690

SIZE STANDARD:

X SEE SCHEDULE

13a. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE 8219

Centers for Disease Control and Prevention (CDC) Office of Acquisition Services (OAS) 2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

CODE 18a. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

TELEPHONE NO.

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

SEE ADDENDUM

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

“See Continuation Page”

(Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.207-6

AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

28.

CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN COPIES

TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET

FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL SHEETS SUBJECT

TO THE TERMS AND CONDITIONS SPECIFIED HEREIN.

29.

AWARD OF CONTRACT: REFERENCE OFFER

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (Signature of Contracting Officer)

30b. NAME AND TITLE OF SIGNER (Type or print)

30c. DATE SIGNED

31b. NAME OF CONTRACTING OFFICER (Type or print)

Candice L Simmons

31c. DATE SIGNED

32a. QUANTITY IN COLUMN 21 HAS BEEN 33. SHIP NUMBER 34. VOUCHER NUMBER

RECEIVED INSPECTED

PARTIAL FINAL

36. PAYMENT 37. CHECK NUMBER

32b. SIGNATURE OF AUTHORIZED GOV’T REPRESENTATIVE 32c. DATE COMPLETE PARTIAL FINAL

41a. I CERTIFY THIS AMOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC’D 42d. TOTAL CONTAINERS

40. PAID BY

AUTHORIZED FOR LOCAL REPRODUCTION SEE REVERSE FOR OMB CONTROL NUMBER AND PAPERWORK BURDEN STATEMENT STANDARD FORM 1449 (10-95)

ACCEPTED, AND CONFORMS TO THE

CONTRACT, EXCEPT AS NOTED

35. AMOUNT VERIFIED

CORRECT FOR

17a. CONTRACTOR/

OFFEROR

FACILITY

CODE

IS CHECKED

Page i

TABLE OF CONTENTS

Section Document/Clause/Provision Page No.

A Standard Form 1449 1

B Continuation of SF1449 (Block 19 – 24) 1

Instructions, Conditions, And Notices To Offerors

Evaluation Factors for Awards

C Contract Clauses 37

D Contract Documents, Exhibits or Attachments 60

E Solicitation Provisions 61

Contract No. 75D301-20-Q-71779

SECTION B - CONTINUATION CONTINUATION OF SF1449

Base Year

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE NOT TO EXCEED

0001 TBTC Study Monitoring

On Site Monitoring per Sections 1-11 of Performance Work Statement (pgs, 3-16 os solicitation).

Base Year (Contract Yr. 1) Period of Performance - September 29, 2020 through September 28, 2021.

This is a TIme and Material CLIN.

1 Job $ $

0002 Travel and Other Direct Costs, or ODCs

This is a Cost Reimbursable CLIN. All travel will be reimbursed in accordance with the Federal Travel Regulations. This CLIN is subject to FAR 52.232-20 “Limitation of Cost”.

Period of Performance - September 29, 2020 through September 28, 2021.

1 Job $ $

$ 10,000.00 Plug Number to be used in developing Price Proposals.

Option 1 Option Year 1 Items:

1001 TBTC Monitoring

On Site Monitoring per Sections 1-11 of Performance Work Statement (pgs, 3-16 os solicitation).

Option Year 1 (Contract Yr. 2) Period of Performance - September 29, 2021 through September 28, 2022.

This is a TIme and Material CLIN.

1 Job $ $

1002 Travel and Other Direct Costs, or ODCs accordance with the Federal Travel Regulations. This CLIN is subject to FAR 52.232-20 “Limitation of Cost”.

Period of Performance - September 29, 2021 through September 28, 2022.

$ 10,000.00 Plug Number to be used

Option 2 Option Year 2 Items:

2001 TBTC Monitoring

On Site Monitoring per Sections 1-11 of Performance Work Statement (pgs, 3-16 os solicitation).

Option Year 2 (Contract Yr. 3) Period of Performance - September 29, 2022 through September 28, 2023.

This is a TIme and Material CLIN.

1 Job $ $

2002 Travel and Other Direct Costs, or ODCs

This is a Cost Reimbursable CLIN. All travel will be reimbursed in accordance with the Federal Travel Regulations. This CLIN is subject to FAR 52.232-20 “Limitation of Cost”.

Period of Performance - September 29, 2022 through September 28, 2023.

1 Job $ $

$10,000.00 Plug Number to be used

Option 3 Option Year 3 Items:

3001 TBTC Monitoring

On Site Monitoring per Sections 1-11 of Performance Work Statement (pgs, 3-16 os solicitation).

Option Year 3 (Contract Yr. 4) Period of Performance - September 29, 2023 through September 28, 2024.

This is a TIme and Material CLIN.

1 Job $ $

3002 Travel and Other Direct Costs, or ODCs

This is a Cost Reimbursable CLIN. All travel will be reimbursed in accordance with the Federal Travel Regulations. This CLIN is subject to FAR 52.232-20 “Limitation of Cost”.

Period of Performance - September 29, 2023 through September 28, 2024.

1 Job $ $

$ 10,000.00 Plug Number to be used

Option 4 Option Year 4 Items:

4001 TBTC Monitoring

On Site Monitoring per Sections 1-11 of Performance Work Statement (pgs, 3-16 os solicitation).

Option Year 4 (Contract Yr. 5) Period of Performance - September 29, 2024 through September 17September 28, 2025.

This is a TIme and Material CLIN.

Period of Performance - September 29, 2023 through September 28, 2024.

1 Job $ $

4002 Travel and Other Direct Costs, or ODCs accordance with the Federal Travel Regulations. This CLIN is subject to FAR 52.232-20 “Limitation of Cost”.

Period of Performance - September 29, 2024 through September 28, 2025.

$10,000.00 Plug Number to be used in developing Price

B.1 Recapitulation:

Time and Material Travel TOTAL COSTS

Base Period - 09/29/2020 through 09/28/2021

$ TBD $ TBD $ TBD

First Option Period - 09/29/2021 through 09/28/2022

$ TBD $ TBD $ TBD

Second Option Period - 09/29/2022 through 09/28/2023

$ TBD $ TBD $ TBD

Third Option Period - 09/29/2023 through 09/28/2024

$ TBD $ TBD $ TBD

Fourth Option Period - 09/29/2024 through 09/28/2025

$ TBD $ TBD $ TBD

Total Costs $ TBD $ TBD $ TBD

B.2 Suggested Labor Categories per Year - The suggested labor categories are suggestions based on historical data related to similar requirements under the contract. Offerors are not required to use these labor categories or exact amounts/number of hours. They are only provided as an example to the Offeror.

Suggest Labor Categories & Estimated Level of Effort

Item Labor Category Hours Rate PRICE

Per Year

Contract Manager 200 $ TBD $ TBD

Senior Clinical Research Associate 350 $ TBD $ TBD

Medical Monitor 125 $ TBD $ TBD

Clinical Research Associate (Domestic) 2000 $ TBD $ TBD

Clinical Research Associate (International) 2000 $ TBD $ TBD

Administrative 150 $ TBD $ TBD

Data Analyst 830 $ TBD $ TBD

Technical Writer 100 $ TBD $ TBD

Total 5,755 $ TBD $ TBD

There are no clauses/provisions included in this section.

PERFORMANCE WORK STATEMENT

Title: Tuberculosis Trials Consortium Clinical Research

Consortium Monitoring, September 29, 2020 – September 28, 2025

SECTION 1 – BACKGROUND

Since the late 1940s the U.S. Public Health Service (USPHS), and the Department of Veterans Affairs have conducted studies of anti-TB medications. In the 1960’s, the U.S. TB control and clinical research programs were transferred from their original location in Washington DC to the National Communicable Disease Center (now CDC) in Atlanta.1 In the 1980s, when funding for TB control was declining, support for TB drug trials also diminished. With the resurgence of TB, strong federal support for TB control was restored in 1992. CDC renewed its engagement with TB clinical trials in 1993; an open competition funded a group of trial-capable sites for a period of 5 years (1993–1998).

Among site characteristics sought were: access to significant numbers of TB patients, experience in the conduct of clinical trials, the presence of a highly qualified clinical team, and a credible plan for recruitment, management, and follow-up of trial participants. This trial, initially named USPHS Study 22, enrolled 1,075 TB participants from sites in the U.S. and Canada.2

In 1997 CDC and the investigators from these sites decided to reorganize their activities, creating the TB Trials Consortium, or TBTC. TBTC is based in the Clinical Research Branch (CRB) of CDC’s Division of Tuberculosis Elimination (DTBE). The CRB includes medical officers, epidemiologists, health scientists, clinical research specialists, laboratorians, data analysts, data managers, statisticians, and contract specialists.

Formal by-laws for TBTC were adopted in 1998, establishing a central Steering Committee, made up of one representative from each site and one from CDC, as well as several executive committees:

Core Science Group (CSG); Implementation and Quality Committee (IQC); Publications and Presentations committee(P&P); and Advocacy and External Relations (AER). The purpose of the Steering Committee was to develop a long-term comprehensive scientific agenda for the TBTC. An Executive Affairs Group (EAG), composed of committee chairs and CRB leadership, was to serve as the executive arm of the Steering Committee, and was responsible for day-to-day decision-making.

A new funding announcement proposes to award contracts to a new group of TBTC trial sites for the next 10-year cycle, from September 2020 to September 2030 of which the expert monitoring skills of a contract research organization (CRO) will be required. It is the intent of the DTBE that TBTC continue its efforts to conduct therapeutic, diagnostic, and preventive research in support of the CDC goal of TB elimination. Clinical research monitoring of the TBTC clinical trials must be relevant to those locations where the research is conducted, and programmatically relevant to the TB control program of the United States and the mission of domestic TB elimination. This monitoring contract requirement will be for five years.

1 Binkin NJ, Vernon AA, Simone PM, et al. Tuberculosis prevention and control activities in the United States:

an overview of the organization of tuberculosis services. Int J Tuberc Lung Dis. 1999;3:663-74.

2 Benator D, Bhattacharya M, Bozeman L, et al., and the Tuberculosis Trials Consortium. Rifapentine and isoniazid once a week versus rifampicin and isoniazid twice a week for treatment of drug-susceptible pulmonary tuberculosis in HIV-negative patients: a randomised clinical trial. Lancet. 2002;360:528-34

SUBSECTION A – DEFINITIONS

TBTC Tuberculosis Trials Consortium

DCC Data & Coordinating Center of the TBTC, housed within CDC’s Division of TB Elimination

IND Investigational new drug

CRO Contract research organization

PK Pharmacokinetics

PD Pharmacodynamics

PG Pharmacogenomics

TBTC2 TBTC’s custom-designed, web-based, study management system used for electronic data capture, study product management and accountability, site information reporting, and dissemination of quality assurance reports

SECTION 2 – PURPOSE

The purpose of this procurement is to provide clinical research organization (CRO) monitoring support to the clinical trials and clinical research performed by the TBTC throughout the five-year performance period 2020 -2025 of this contract. While TBTC network, emphasis will be given to studies of latent TB infection in the United States, and studies of active TB disease both domestically and internationally, the awarded CRO will perform tasks for the planning, pre-study and TBTC-specific activities; TBTC clinical site management and monitoring; reporting; and internal quality assurance and audits.

SECTION 3 – SCOPE OF WORK

The scope of this network of monitoring activities may range from small laboratory-based and/or single site studies to large Phase 2 and long-term Phase 3 clinical trials to evaluate new TB drugs and drug regimens, diagnostics, and preventive interventions to ensure clinical trial quality and participant safety, adherence to U.S. and international standards of good clinical practice, data collection and reporting, regulatory compliance, accurate protocol implementation, internal quality management and study product accountability. As this trial is conducted under IND, has the potential to be audited by US Food & Drug Administration and/or European Medicines Agency. The following will be required:

• On-site initiation visits for all participating sites prior to first enrollment;

• On-site periodic monitoring visits;

• On-site close out visits;

• Tracking of monitoring activities and deficiencies; and

• Reports of monitoring findings.

To support the on-site monitoring, the DCC team will provide:

• Access to and training for the TBTC2 study management system;

• Protocol and case report form training;

• Guidance on protocol implementation;

• Input into study monitoring plan incorporating principles of risk-based monitoring;

• Documentation of obligations transferred from sponsor to CRO;

• Central monitoring of study data and activities;

• Quality assurance of study data; and

• Pre-site visit reports and information prioritizing tasks at on-site visits.

SECTION 4 - Tasks to be Performed

Each vendor as an independent organization and not as an agent of the Government, furnish all the necessary services, qualified personnel, material, equipment, and facilities to conduct monitoring activities for the TBTC clinical trials sites. CRB staff and/or external CRO site monitors will evaluate adherence to U.S. and international standards of good clinical practice (GCP), good clinical laboratory practice (GCLP), data collection and reporting, regulatory compliance, accurate protocol implementation, internal quality management, and test product accountability. Site visits will be performed once or twice yearly, or as-needed to review specific protocols, provide training on protocol conduct, review internal quality assurance plans, and document error resolution.

The expected duration of this contract requirement is five years. For the five-year performance period, the Contractor will focus on the following monitoring tasks:

Task 4.1 – Planning, Pre-Study, and TBTC-Specific Activities

1.1 Establish an identified project team, including, but not limited to: project manager, clinical trial manager, clinical research associate, regulatory specialist, and quality specialist.

1.2 Author, as needed, meeting minutes for all attended TBTC meetings to comply with Sponsor-established format. Provide meeting minutes to CRB staff within 3 days of meeting.

1.3 Author, as needed, internal Standard Operating Procedures (SOPs) associated with processes necessary to comply with the FDA and Sponsor-established requirements. Provide CRB access to CRO SOPs for review

1.4 Develop and maintain study procedure manual(s) and other manuals as necessary, in collaboration with CDC/CRB staff

Task 2 –TBTC Clinical Site Management and Monitoring

2.1 Ensure that the conduct of all trials are in compliance with approved protocol(s), Good Clinical

Practice (GCP), Good Clinical Laboratory Practice (GCLP), Human Subjects Projection (HSP), and all applicable regulatory and local requirements

2.2 Ensure site and IRB/IEC is in compliance with Federal Wide Assurance (FWA), including review of all participant consent forms to assure compliance with applicable regulations

2.3 Ensure clinical site staff have documentation of proficiency in: GCP, HSP, and Investigator responsibilities

2.4 Organize and provide site training per sponsor request or site-specific needs

2.5 In concert with sponsor, develop and implement a robust risk-based monitoring plan with a matrix of study risks, description of risk evaluation, thresholds for action, and quality metric deliverables, which describes visit types and frequencies and activities performed, and presents findings of visits with quantitative measures allowing evaluation of time trends and comparisons among sites

2.6 Develop and implement a detailed communication plan outlining communication and issue escalation between vendor, CRB and site staff

2.7 Develop and maintain a system to monitor clinical site items that require expiration dates such as site personnel professional licensures, equipment inspections, temperature monitoring or calibration, laboratory license(s), and requisite local regulatory approvals by ethics committees and/or national boards;

2.8 Develop and implement clinical site quality management programs including source data validation and quality audits

2.9 Develop and implement clinical site quality checks on study personnel performance, and on study specific regulatory and SOP documents

2.10 Perform protocol-specific on-site clinical monitoring at site initiation, routine and close-out visits; and at pharmacies and laboratory as applicable

2.11 Perform protocol-specific remote monitoring including monitoring participant enrollment and tracking of quality metrics over time

2.12 Assist sites with development and maintenance of screening, recruitment, retention, pharmacy, and regulatory compliance/quality management plans

2.13 Review site performance on an on-going basis and work directly with site staff to improve processes and achieve best practices

2.14 Conduct accountability procedures and coordinate and manage end of study disposition

2.15 Utilize an existing clinical trial management system that includes real-time data entry and central monitoring tools

Task 3 – Reporting to Sponsor

3.1 The vendor must document findings during or following each on-site monitoring visit with clinical research sites. Specifically, the vendor shall:

3.1.1 Communicate with the CRB team immediately if an urgent issue or question arises during an on-site visit. Urgent issues or questions include, but are not limited to, issues preventing the monitor from conducting visit activities and protocol compliance issues that may result in unnecessary harm to study participants.

3.1.2 Within 3 business days of completion of visit, send email to the CRB team with high-level, structured summary of visit findings. At a minimum the summary of visit findings should include an overall summary of the monitoring visit, the completion status of activities slated for the visit, and a description of any notable findings and/or deficiencies;

3.1.3 Within 10 business days of completion of visit, send a draft monitoring report to CRB team, following agreed upon report format and communication method. At a minimum the draft monitoring report should include the date of the activity and the individual(s) conducting and participating in it; a summary of the data or activities reviewed; a description of any noncompliance, potential noncompliance, data irregularities, or other deficiencies identified; a description of any actions taken, to be taken, or recommended, including the person responsible for completing actions and the anticipated date of completion;

3.1.4 Within 30 business days of completion of visit, send a final monitoring report to CRB team, following agreed upon report format and communication method. At a minimum the draft monitoring report should include the date of the activity and the individual(s) conducting and participating in it; a summary of the data or activities reviewed; a description of any noncompliance, potential noncompliance, data irregularities, or other deficiencies identified; a description of any actions taken, to be taken, or recommended, including the person responsible for completing actions and the anticipated date of completion;

3.1.5 Within 10 days of monitor’s review of the resolution or corrective action of any deficiencies noted during the monitoring visit, send a monitoring follow-up report. At a minimum the monitoring follow-up report should include the current status of each deficiency, a summary of the issue(s), the resolution or corrective action taken, whether those actions adequately resolved the issue, and whether further follow-up is necessary;

3.1.6 Document participant-specific monitoring findings in the TBTC2 study management system at the time of the site visit;

3.1.7 Respond to any requests for clarification from summary email or monitoring report within 3 business days of receipt;

3.1.8 Maintain a log of findings from site visits. At a minimum the log of findings must address the entry date and current status of each finding, a summary of the issue(s), and the proposed resolution strategy;

3.1.9 Communicate with study site teams to document resolution of any findings; and

3.1.10 Maintain a log of participant charts reviewed in the CRB-specified format. At a minimum the log of participant charts should address/include the quantity of charts reviewed per site, the identification number of each reviewed chart, specific items reviewed in each chart, and any findings identified.

3.2 The Vendor must provide monthly reports of remote monitoring interactions with clinical research sites, including a summary of issues or queries identified, resolved, and not resolved;

and recommendation for training or implementation guidance needed at sites.

3.3 The Vendor must provide quarterly high-level, cumulative, summary reports of monitoring findings and pending follow-up log items, with site-specific assessments of study implementation and recommendations for sponsor action.

Task 4 –Internal Quality Assurance and Audits

4.1 Maintain inspection readiness state

4.2 Monitor and prepare reports for study Sponsor on progress towards monitoring goals

4.3 Develop, implement and maintain an effective internal Quality Assurance, Quality Control and

Audit Plan for all of the vendor’s coordinating and document preparation activities to ensure compliance with federal and local regulations

4.4 Utilize an established internal system to measure, monitor and provide feedback on performance of personnel who interact with sites with the goal of continually improving staff performance

Task 5 – Investigational Product Management

5.1 If necessary, identify and establish contractual agreements with clinical research vendors to support studies as needed, including, but not limited to:

5.1.1 Develop and implement a study supplies procurement and management plan as well as an Investigational Product Accountability Plan

5.1.2 Obtain necessary approvals for import of IP and clinical trial materials including storage and shipment

5.1.3 Ensure IP is labeled as investigational, according to IND/IDE requirements

5.1.4 Coordinate and manage investigational product shipment, delivery, proper storage, and inventory at clinical sites

Specific contract requirements include the following:

Offerors whose proposal includes a CRO who reside outside of the United States may be accepted.

Listed below are three possible alternatives. While the three ways are shown as alternatives that are only a sample of three different alternatives. Offerors are able to and encouraged to offer different alternatives as they see fit. These three alternatives shown below are in no way meant to infer that these are the only available alternatives and that no other alternatives will be considered.

Rather they are meant to be a sample of the available alternatives so as to encourage participation by potential offerors who may otherwise not be able to submit a proposal.

Alternative (1) – the offeror may be a U.S. organization that proposes to sub-contract with an organization outside of the U.S. on behalf of the U.S. government (CDC), with the purpose of providing CRO monitoring support to TBTC Contractors conducting clinical trials for treatment or prevention of TB. In this instance, the offeror’s proposal will include a sub contractual arrangement with an organization outside of the U.S. The international, sub-contracted organization would be chosen so as to provide efficient access to more experienced, culturally knowledgeable monitors familiar with local site customs than would be available at the organization of a primary offeror.

This arrangement will require close coordination between the two organizations.

Under Alternative 1, the U.S organization will provide:

- expertise in clinical trials, in Good Clinical Practice, in Good Laboratory Practice, and in human subject protections, and

- experience in the management of monitoring research contracts with U.S. government agencies (such as the Centers for Disease Control and Prevention), experience in monitoring compliance with regulatory requirements applicable to clinical trials, and experience in sub-contracting procedures.

Alternative (2) – the offeror may be a non-U.S. organization eligible to receive funds (and institute research monitoring activities) directly from (and for) a U.S. government agency. In this instance, the offeror should submit a proposal that is inclusive of all required elements, and the contract would be executed directly and solely with the non-U.S. organization. Non-U.S. (“international”) offerors opting for this approach are expected to be organizations with substantial and well-documented experience in the conduct of monitoring clinical trials, significant experience in monitoring tuberculosis research, significant prior successful experience in receiving and responding to clinical research funding for, and experienced administrative staff familiar with U.S. government contracting procedures.

Alternative (3) – the offeror may be a qualified international organization which elects to obtain supporting services and expertise from a U.S. organization through the mechanism of a subcontract.

As in Alternative #2, the offeror must be a non-U.S. organization eligible to receive funds (and institute research activities) directly from (and for) a U.S. government agency. And as in Alternative #2, in this approach, the international organization/ offeror is expected to demonstrate (i) substantial and well-documented experience in the conduct of monitoring clinical trials, (ii) significant experience in monitoring tuberculosis research, (iii) significant prior successful experience in receiving and responding to U.S. clinical research funding, and (iv) the availability of experienced administrative staff familiar with U.S. government contracting procedures. The difference from Alternative #2 is that in this approach, the offeror proposes to obtain some portion of items i-iv through a subcontract with an organization that can provide or strengthen any of these elements.

An offeror applying under Alternative #3 must be fully qualified to accomplish administrative aspects of the contract and sub-contract, and should be of sufficient technical strength that it could reasonably be expected to manage its own technical support services.

In each of these 3 alternatives, and any other alternatives that offer may propose, the offeror (with its subcontractors, if any) should demonstrate (a) the availability of significant technical strengths in the implementation of monitoring TB clinical trials, and (b) the availability of all necessary administrative and regulatory expertise to fulfill the requirements and objectives of this contract.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

Not applicable

SECTION 6 – PERIOD OF PERFORMANCE

BASE YEAR:

The vendor shall perform contract research organization (CRO) monitoring tasks that include planning, pre-study, and TBTC specific activities; clinical site management and monitoring; reporting;

and internal quality assurance and audits for the Tuberculosis Trials Consortium (TBTC) clinical trials and clinical research studies of latent TB infection in the United States and studies of active TB disease both domestically and internationally. The government estimates that 0-3 new studies may be initiated during this phase.

OPTION YEAR ONE:

The vendor shall perform contract research organization (CRO) monitoring tasks that include planning, pre-study, and TBTC specific activities; clinical site management and monitoring; reporting;

and internal quality assurance and audits for the Tuberculosis Trials Consortium (TBTC) clinical trials and clinical research studies of latent TB infection in the United States and studies of active TB disease both domestically and internationally. The government estimates that 0-2 new studies may be initiated during this phase.

OPTION YEAR 3:

The vendor shall perform contract research organization (CRO) monitoring tasks that include planning, pre-study, and TBTC specific activities; clinical site management and monitoring; reporting;

and internal quality assurance and audits for the Tuberculosis Trials Consortium (TBTC) clinical trials and clinical research studies of latent TB infection in the United States and studies of active TB disease both domestically and internationally. The government estimates that 0-2 new studies may be initiated during this phase.

OPTION YEAR 4:

The vendor shall perform contract research organization (CRO) monitoring tasks that include planning, pre-study, and TBTC specific activities; clinical site management and monitoring; reporting;

and internal quality assurance and audits for the Tuberculosis Trials Consortium (TBTC) clinical trials and clinical research studies of latent TB infection in the United States and studies of active TB disease both domestically and internationally. The government estimates that 0-4 new studies may be initiated during this phase.

OPTION YEAR 5:

The vendor shall perform contract research organization (CRO) monitoring tasks that include planning, pre-study, and TBTC specific activities; clinical site management and monitoring; reporting;

and internal quality assurance and audits for the Tuberculosis Trials Consortium (TBTC) clinical trials and clinical research studies of latent TB infection in the United States and studies of active TB disease both domestically and internationally. The government estimates that 0-2 new studies may be initiated during this phase.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

Base Year:

Task Description Quantity of Copies

Delivery Date Format Deliver To

3.1.2 High-Level

Structured Summary of Findings

1 or more

Within 3 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.3. Draft

Monitoring Report

1 or more

Within 10 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.4 Final

Monitoring Report

1 or more

Within 30 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.5 Resolution or

Corrective Action or Monitoring Follow-Up Report

1 or more

Within 10 days of monitor’s review of the resolution or corrective action of any deficiencies noted during the

Word document tbtcresearchadmin@cdc.gov, CO, and COR mailto:tbtcresearchadmin@cdc.gov monitoring visit

3.1.8 Maintain a log

of findings

1 or more

Within 30 days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.10 Maintain a log

of participant charts reviewed

1 or more

Within 30 days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO and COR

3.2 Reports of

Remote Monitoring Interactions

12 Monthly Word document tbtcresearchadmin@cdc.gov, CO and COR

3.3 High-level, Cumulative, Summary Reports

4 Quarterly Word document tbtcresearchadmin@cdc.gov, CO and COR

Option Year 1:

Delivery Date Format Deliver To

3.1.2 High-Level

Structured Summary of Findings

1 or more

Within 3 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.3. Draft

Monitoring Report

1 or more

Within 10 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.4 Final

Monitoring Report

1 or more

Within 30 business days of completion

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.5 Resolution or

Corrective Action or Monitoring Follow-Up Report

1 or more

Within 10 days of monitor’s review of the resolution or corrective action of any deficiencies noted during the monitoring visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.8 Maintain a log

of findings

1 or more

Within 30 days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.10 Maintain a log

of participant charts reviewed

1 or more

Within 30 days of completion of visit

Word document tbtcresearchadmin@cdc.gov,

3.2 Reports of

Remote Monitoring Interactions

12 Monthly Word document tbtcresearchadmin@cdc.gov, CO and COR

3.3 High-level, Cumulative, Summary Reports

4 Quarterly Word document

Option Year 2:

Delivery Date Format Deliver To

3.1.2 High-Level

Structured Summary of Findings

1 or more

Within 3 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.3. Draft

Monitoring Report

1 or more

Within 10 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.4 Final

Monitoring Report

1 or more

Within 30 business days of completion

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.5 Resolution or

Corrective Action or Monitoring Follow-Up Report

1 or more

Within 10 days of monitor’s review of the resolution or corrective action of any deficiencies noted during the monitoring visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.8 Maintain a log

of findings

1 or more

Within 30 days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.10 Maintain a log

of participant charts reviewed

1 or more

Within 30 days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO and COR

3.2 Reports of

Remote Monitoring Interactions

12 Monthly Word document tbtcresearchadmin@cdc.gov, CO and COR

3.3 High-level, Cumulative, Summary

4 Quarterly Word document tbtcresearchadmin@cdc.gov, Reports

Option Year 3:

Delivery Date Format Deliver To

3.1.2 High-Level

Structured Summary of Findings

1 or more

Within 3 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.3. Draft

Monitoring Report

1 or more

Within 10 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.4 Final

Monitoring Report

1 or more

Within 30 business days of completion

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.5 Resolution or

Corrective Action or Monitoring Follow-Up Report

1 or more

Within 10 days of monitor’s review of the resolution or corrective action of any deficiencies noted during the monitoring visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.8 Maintain a log

of findings

1 or more

Within 30 days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.10 Maintain a log

of participant charts reviewed

1 or more

Within 30 days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO and COR

3.2 Reports of

Remote Monitoring Interactions

12 Monthly Word document tbtcresearchadmin@cdc.gov, CO and COR

3.3 High-level, Cumulative, Summary Reports

4 Quarterly Word document

Option Year 4:

Delivery Date Format Deliver To

3.1.2 High-Level

Structured Summary of Findings

1 or more

Within 3 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.3. Draft

Monitoring Report

1 or more

Within 10 business days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.4 Final

Monitoring Report

1 or more

Within 30 business days of completion

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.5 Resolution or

Corrective Action or Monitoring Follow-Up Report

1 or more

Within 10 days of monitor’s review of the resolution or corrective action of any deficiencies noted during the monitoring visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.8 Maintain a log

of findings

1 or more

Within 30 days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO, and COR

3.1.10 Maintain a log

of participant charts reviewed

1 or more

Within 30 days of completion of visit

Word document tbtcresearchadmin@cdc.gov, CO and COR

3.2 Reports of

Remote Monitoring Interactions

12 Monthly Word document tbtcresearchadmin@cdc.gov, CO and COR

3.3 High-level, Cumulative, Summary Reports

4 Quarterly Word document

SECTION 8 – REFERENCE MATERIALS

N/A

SECTION 9 – PLACE OF PERFORMANCE

Awarded TBTC Vendor’s business location and seven (7) to twelve (12) clinical research sites within the United States and Canada, and three (3) to five (5) international sites in countries of high TB prevalence and incidence (total number of sites 10-17; total number of awards variable because some contracts may include multiple clinical sites) to be determined. TBTC Monitoring services will be required at these locations as well as the offeror’s place of business.

SECTION 10 – TRAVEL

Travel to implementing clinical sites, research pharmacies, and PK analysis laboratories will be required to complete work in this contract.

Base Year:

International Travel: 4 international trips for a cumulative total of 16 days TDY will be required for performance in the base year. This is a maximum.

Domestic Travel: 3 trips to Atlanta, GA for a cumulative total of 10 days TDY will be required for performance in the base year.

Domestic Travel: 12 domestic US trips for a cumulative total of 48 days TDY will be required for performance in the base year. This is a maximum.

Option Year 1:

International Travel: 5 trips for a cumulative total of 22 days TDY will be required for performance in the base year. This is a maximum.

Domestic Travel: 2 trips to Atlanta, GA for a cumulative total of 6 days TDY will be required for performance in the base year.

Option Year 2:

International Travel: 13 trips for a cumulative total of 55 days TDY will be required for performance in the base year. This is a maximum.

Domestic Travel: 2 trips to Atlanta, GA for a cumulative total of 6 days TDY will be required for

Option Year 3:

International Travel: 13 trips for a cumulative total of 55 days TDY will be required for performance in the base year. This is a maximum.

Option Year 4:

International Travel: 10 trips for a cumulative total of 45 days TDY will be required for performance in the base year. This is a maximum.

SECTION 11 – SPECIAL REQUIREMENTS

1. The contractor will need to utilize TBTC2, which is the web application that is used for data management of TBTC’s clinical research studies. Requests for access to TBTC2 must be sent to tbtcresearchadmin@cdc.gov at least one week prior to planned site visits.

2. Requirements for Procurements Involving Privacy Act Records

A. Privacy Act

It has been determined that this contract is not subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records on individuals.

The System of Records Notice (SORN) that is applicable to this contract is: N/A

The disposition to be made of the Privacy Act records upon completion of contract performance is:

TBD

SECTION 12 - Instructions, Conditions, And Notices To Offerors

1. Inquiries (Jul 2017)

Inquiries concerning the solicitation document should be submitted in writing to the issuing office.

Any additions, deletions, or changes to the solicitation will be made by an amendment. OFFERORS ARE INSTRUCTED SPECIFICALLY TO CONTACT ONLY THE SOLICITATION CONTRACTING OFFICE IN CONNECTION WITH ANY ASPECT OF THIS REQUIREMENT PRIOR TO CONTRACT AWARD. PROPOSALS AND ALL CORRESPONDENCE RELATING TO THE SOLICITATION DOCUMENT SHALL BE SUBMITTED TO THE CONTRACTING OFFICE. Inquiries regarding this solicitation must be received by the Contracting Officer, Mrs. Candice L. Simmons at iie3@cdc.gov no later than 10:00 am EST on June 25, 2020.

mailto:TBTCStudy35@cdc.gov mailto:iie3@cdc.gov

(End of Provision)

2. Information in Technical Proposal (Jul 2017)

(a) The technical proposal should be in as much detail as you consider necessary to reflect a clear understanding of the nature of the work being undertaken.

(b) The technical proposal must not contain reference to cost; however, resource information, such as data concerning labor hours and categories, material, subcontracts, etc., must be contained in the technical proposal so that your understanding of the statement of work can be evaluated.

3. Proposal Format

(a) Your proposal for this acquisition must be prepared in two parts: a) Technical Proposal (Volume I), and b) Business Proposal (Volume II). Each part shall be separate and complete in itself so that evaluation of one may be accomplished independently of evaluation of the other.

(b) The technical proposal shall not contain reference to cost; however, resource information, such as data concerning labor hours and categories, material, subcontracts, etc., must be contained in the technical proposal so that your understanding of the Performance Work Statement can be evaluated. The technical proposal must disclose your technical approach in sufficient detail to provide a clear and concise presentation that addresses, but is not limited to, the requirements of the technical proposal instructions. Additional information about the contents required for the Technical Proposal and Business Proposal, can be found at numbers 4 (Technical Proposal Instructions) and 5 (Business Proposal Instructions) of SECTION 12 titled “Instructions, Conditions, And Notices To Offerors”, respectively.

(c) The proposal must be signed by an official authorized to bind your organization.

(d) Proposals shall be submitted electronically. Offerors are permitted to submit more than one proposal submission.

(e) Offerors shall submit one (1) (non-editable PDF) copy of your technical proposal; and one (1) (Excel and non-editable PDF) copy of your business proposal. The technical and business proposal shall each be marked as “Original”.

(f) Electronic Proposal submissions must be addressed to the attention of Mrs. Candice L. Simmons and submitted as well as received at iie3@cdc.gov no later than 3:00 PM EST on 07/15/2020.

NOTE: Proposals will not be accepted via facsimile.

(g) Facsimile proposals are not authorized.

(h) The Government will evaluate proposals in accordance with the evaluation criteria set forth in SECTION 13 titled “Evaluation Factors for Award”.

4. TECHNICAL PROPOSAL INSTRUCTIONS

(a) The Vendor must submit a detailed technical proposal including information on the capabilities of the Vendor to respond to the requirements as defined in the PWS at SECTION 4 titled “Tasks to be Performed”. Proposals which merely offer to conduct a program in accordance with the requirements of the Government’s Performance Work Statement (PWS) on pgs. 3-19 of this solicitation will not be eligible for award. The technical proposal should be in as much detail as you consider necessary (within the 30-page limitation) to reflect a clear understanding of the nature of the work being undertaken.

(b) The written technical proposal shall include, at a minimum, the following sections which vendors shall use as the Table of Contents for the Technical Proposal:

(1) TAB A - Cover Page (including solicitation number and name of Offeror)

(2) TAB B - Table of Contents, Appendices, Resumes of Key Personnel, CVs/Resumes, Proposal Preperation Certification (Attachment D.2)

(3) TAB C - Concise Presentation of each of the Evaluation Criteria for the Overall Contract:

(a) Technical Approach

(b) Staffing/Management Plan

(c) Relevant Experience

(d) Quality Assurance

(4) TAB D - Past Performance

(5) TAB E - Sub-Contracting Plan (Attachment D.4)

(c) The technical proposal shall not exceed 30 pages, excluding TAB A (cover page), TAB B (table of contents, appendices, resumes of key personnel, CVs/resumes), and TAB E (Subcontracting Plan).

The technical proposal shall be single spaced, single-sided, and on standard 8½ X 11-inch pages with 12 font characters. All pages in the written technical proposal must be sequentially numbered excluding TABS A, B, and E . Any pages beyond the first 30 pages will be ignored in the evaluation process. The technical proposal should “stand alone” with the appendices used only for clarifying or backup information. The technical proposal should be in as much detail as you consider necessary (within the thirty (30) page limitation) to reflect a clear understanding of the nature of the work being undertaken. The Contractor shall describe in a clear and succinct statement the problem, scope, purpose, and objectives of this solicitation in the Contractor’s own words to demonstrate his/her understanding of the intent and requirements of the contract and any potential challenges which may be encountered in completing the tasks/subtasks. The technical proposal must disclose your technical approach in sufficient detail to provide a clear and concise presentation that addresses, but is not limited to, the requirements of the technical proposal. Refer to number L.9(e) above for submission instructions. As part of the technical proposal, the Vendor will be required to submit a cross reference between the RFP and technical proposal to assist in the review.

(d) The Technical Proposal (TABS C, D, and E) should specifically address the following:

The Technical Proposal should include detailed information presented in the order specified below, including the following:

(d)(1) Technical Approach

i. The Offeror’s proposed Technical Approach must demonstrate their proposed technical approach to achieving all tasks outlined in the PWS. The technical approach response shall contain sufficient quantitative details (without reference to cost) to permit a complete and accurate evaluation of the approach from a strictly technical viewpoint. The proposed technical approach shall address the following:

a. A clear presentation of the proposal to ensure adequate monitoring of the proposed clinical study, including monitoring of clinical research sites, pharmacies, and laboratories.

b. A clear description of the Contractor’s approach to ensure the adequate protections of human subjects and adherence to the regulatory requirements of clinical research studies conducted under IND, including any training capacity and certifications the contractor possesses in this regard.

c. An understanding of possible risks and strategies to mitigate any anticipated risks should they arise.

d. An appropriate Project Management Plan.

e. A description of the proposed communication pathways between the contractor, clinical research site, and the DCC.

ii. As part of the proposed Technical Approach offeror shall review the following scenario and provide a detailed monitoring plan, including on-site and remote monitoring utilizing principles of risk-based monitoring. A description of metrics for tracking completion of monitoring activities and reporting to the sponsor should also be included. The proposed study parameters are:

TBTC Study A is a Phase III, TB prevention study evaluating a novel Latent Tuberculosis Infection

(LTBI) treatment against standard of care. Total enrollment is 3,000 participants, 1,500 per arm.

Basic eligibility criteria are: non-pregnant females and males, age 5 years and older, who are either contacts of an infectious TB case, or have evidence of TB infection in the form of a positive quantiferon test result.

The study is being conducted at up to 12 clinical research sites in the United States and one site each in Canada, South Africa, Uganda and the United Kingdom. The study is being done under Investigational New Drug Application (IND) with the US FDA, and the pharmaceutical partner is interested in pursing licensure for the drug in both the US and through the European Medicine Agency (EMA). The CDC is the trial sponsor.

Participants are randomized to receive either the investigational regimen or standard of care.

There are multiple allowable standard of care regimens depending on the specific standard used in the various trial settings. As such, time on treatment can vary but will not exceed 6 months.

Participants are followed for 24 months post treatment start date. Total expected study duration is approximately 60 months.

There is an embedded intensive pharmacokinetic sub-study for participants randomized to receive the investigational treatment with a sample size of 100 children aged 5-12, 75 adolescents aged 12-18, and 50 adults.

Primary objectives of the study are:

1. Safety as defined by proportion of participants who discontinue assigned study treatment due to an adverse drug reaction

2. Effectiveness as defined by proportion of participants with culture confirmed or clinical TB

Secondary objectives of the study are:

1. Tolerability as defined by proportion of participants who completed assigned treatment

2. Efficacy as defined by proportion of participants with culture confirmed or clinical TB among those who completed assigned study treatment

All study data are reported to CDC via a custom, electronic study management system. All electronic case report forms include robust business rules to ensure that logical, complete data are submitted initially. Centralized quality assurance is conducted by the CDC team.

(d)(2) Staffing/Management Plan:

i. List the name of the Project Manager/Senior Clinical Research Associate (CRA), Key

Personnel responsible for overall implementation of the monitoring contract and also that of the key contact for technical aspects of the contract. Discuss the qualifications, experience, and accomplishments of the Project Manager/CRA. State the estimated time to be spent on the project and his/her proposed duties.

ii. List all other CRAs and other…