Federal · SAM.gov · Atlanta, GA

Clinical Trial Management System for TB Clinical Research

Department of Health and Human ServicesIssuing agency·Atlanta, GA·via the SAM.gov Get Opportunities API

3days left

Due Aug 14, 2026·Posted Aug 4, 2026

AI takeaways

The CDC is procuring a cloud-based Clinical Trial Management System (CTMS) to plan, manage, and track clinical trial documents for TB clinical research, to be performed in Atlanta, GA.
Proposals are due August 14, 2026, at 2:00 PM EDT, with a base period of September 1, 2026 through August 31, 2027, plus two 12-month option periods.
The solicitation number is 75D30126Q79181, issued as a Request for Quote (RFQ) under FAR 12.6, unrestricted (full and open competition).
The CTMS must be 21 CFR Part 11 compliant, include role-based access for up to 20 CDC users, 22 trial site accounts, and 50 eISF portal users, and integrate with CDC SAMS and EDC systems.
The contractor must obtain and maintain FedRAMP Low-risk authorization and undergo annual 3PAO assessments.
Questions must be submitted in writing by August 7, 2026, via email to Debra Baker at xvv9@cdc.gov.
The issuing agency is the Department of Health and Human Services, Centers for Disease Control and Prevention.
Requirement: The contractor shall obtain and maintain a FedRAMP authorization at the Low-risk level for the entirety of the contract’s duration.

Term: 12-month base period…
Method: Combined Synopsis/Solicitati…
Documents: 9 files

These takeaways are AI-generated and may be incomplete or wrong. Always verify every detail against the official documents before you bid.

Contact the buyer

Debra Baker

xvv9@cdc.govEmail

Location:

Atlanta, GA 30333

Open in Maps ↗

Notice

2021ed1c024b4cd1a754c90cf3456d24

2026-Q-97423

Method

Combined Synopsis/Solicitation

Duration

12-month base period starting September 1, 2026, with two (2) subsequent 12-month option periods

More health & medical research bids in Georgia, weekly.

We post new health & medical research opportunities in Georgia as agencies publish them. Get them in one email — free, and unsubscribe whenever.

What this bid is asking for

AI-generated

Provide a 21 CFR Part 11 compliant, web-based CTMS with role-based access for up to 20 CDC users, 22 trial site accounts, and 50 eISF portal users.
Integrate the CTMS with CDC's Secure Access Management Services (SAMS) and existing Electronic Data Capture (EDC) system.
Obtain and maintain FedRAMP Low-risk authorization, including annual 3PAO assessments and continuous vulnerability monitoring.
Deliver a configuration and onboarding plan executed within 15–50 days of award, including user acceptance testing and training.
Submit a quotation split into three volumes: Technical Approach & Software Capabilities, Past Performance, and Price Proposal.

Posted Scope of Work

This competitive acquisition is conducted under the streamlined ordering procedures of Federal Acquisition Regulation (FAR) 12.6 and (FAR) 5.203.

(i) This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement contains the only solicitation; proposals are being requested and a written solicitation will not be issued later.

(ii) Solicitation number 75D30126Q79181 is issued as a Request for Quote (RFQ).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-01.

(iv) This acquisition is Unrestricted (Full and Open Competition). The associated North American Industry Classification System (NAICS) code is 513210 (Software Publishers),541511 and the small business size standard is $47.0 Million.

Inquiries shall be sent to Debra Baker by email at vxvv9@cdc.gov and reference solicitation #2026-Q-97423 and title on the subject line.

Scope, read from the documentsAI-generated

The vendor shall provide a 21 CFR Part 11 compliant, web-based CTMS application including 20 CDC user accounts, 22 trial site accounts, and 50 eISF portal users, with technical support and system maintenance. The contractor must obtain and maintain FedRAMP Low-risk authorization, integrate with CDC's Secure Access Management Services (SAMS) and existing Electronic Data Capture (EDC) system, and provide ongoing technical support. Optional tasks include expanded eTMF document storage.

Questions & answers

AI-generated

What is the due date for proposals?

Proposals must be submitted electronically via email no later than August 14, 2026, at 2:00 PM EDT.

Who is the contracting officer and how do I submit questions?

Questions must be submitted in writing using the provided Q&A template by August 7, 2026 via email to the Contracting Officer, Debra Baker at xvv9@cdc.gov.

What is the period of performance?

The period of performance is a 12-month base period starting September 1, 2026, with two subsequent 12-month option periods, through August 31, 2029.

What security compliance is required?

The contractor shall obtain and maintain a FedRAMP authorization at the Low-risk level for the entirety of the contract’s duration.

Documents

Download zip

Questions_Answers Worksheet.xlsxXLSX

Preview Download

SOL-75D30126Q79181 DB.pdfPDF

Preview Download

RFP-CLINICAL TRIAL MANAGEMENT SYSTEM-FE.pdfPDF

Preview Download

AI Use Compliance and Risk Attch 5.pdfPDF

Preview Download

CTMS questions Attachment 4_.pdfPDF

Preview Download

VPAT Report- Attachment 6.docxDOCX

Preview Download

Pricing Schedule Attachment 2-.xlsxXLSX

Preview Download

Letter of Supply Template Attachment 3.docxDOCX

Preview Download

Attachment 1 SOW crosswalk.docxDOCX

Preview Download

Full source recordEvery field SAM.gov published, untouched

Hit

2021ed1c024b4cd1a754c90cf3456d24

Type

Code: k
Value: Combined Synopsis/Solicitation

Type

opportunity

Award

Awardee

Title

Clinical Trial Management System for TB Clinical Research

R Score

Is Active

Yes

Is Canceled

Publish Date

Aug 4, 2026

Descriptions

Content: <p>The Center for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Division of Tuberculosis Elimination (DTBE) Clinical Research Branch (CRB) intends to award a purchase order to purchas
Last Modified Date: Aug 4, 2026

Modified Date

Aug 4, 2026

Response Date

Aug 14, 2026

Modifications

Count: 1

Parent Notice Id

bf06fe9f725e473d9aac9269e46d5301

Response Time Zone

America/New_York

Response Date Actual

Aug 14, 2026

Solicitation Number

2026-Q-97423

Organization Hierarchy

Code

7500

Name

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Type

DEPARTMENT

Level

Status

active

Address

Zip: "20201"
City: "Washington"
State: "DC"
Country: "US"
Street Address: "Hubert H. Humphrey Building 200 Independence Avenue, SW "

Organization Id

100004222

Code

7523

Name

CENTERS FOR DISEASE CONTROL AND PREVENTION

Type

AGENCY

Level

Status

active

Address

Zip: "30333"
City: "Atlanta"
State: "GA"
Country: "US"
Street Address: "1600 Clifton Road"

Organization Id

100007448

Code

75D301

Name

CDC OFFICE OF ACQUISITION SERVICES

Type

OFFICE

Level

Status

active

Address

Zip: "30333"
City: "ATLANTA"
State: "GA"
Country: "USA"
Street Address: "1600 CLIFTON ROAD"

Organization Id

100188028

Type

Combined Synopsis/Solicitation

Title

Clinical Trial Management System for TB Clinical Research

Active

Yes

Detail

Type

Naics

Code: 54151
Type: primary

Title

Clinical Trial Management System for TB Clinical Research

Archive

Date: Aug 29, 2026
Type: auto15

Version

Permissions

IVL

Read: Yes
Create: Yes
Delete: Yes
Update: Yes

Solicitation

Set Aside

NONE

Deadlines

Response: Aug 14, 2026
Response Tz: America/New_York

Organization Id

100188028

Point Of Contact

Type: primary
Email: xvv9@cdc.gov
Full Name: Debra Baker

Type: secondary
Email: vyh1@cdc.gov
Full Name: Liubov Kriel

Classification Code

DA10

Place Of Performance

Zip

30333

City

Code: 4000
Name: Atlanta

State

Code: GA
Name: Georgia

Country

Code: USA
Name: UNITED STATES

Solicitation Number

2026-Q-97423

Additional Reporting

none

Ui Link

https://sam.gov/opp/2021ed1c024b4cd1a754c90cf3456d24/view

History

Links

Self

Href: https://86samdotgovopportunitiesmodern.prod.apps-internal.prod-iae.bsp.gsa.gov/opps/v2/opportunities/2021ed1c024b4cd1a754c90cf3456d24/history{?postedFrom}
Templated: Yes

History

Index: 2
Title: Clinical Trial Management System for TB Clinical Research
Latest: 1
Deleted: 0
Action Date: 2026-08-04T15:16:09.488+00
Action Type: publish
Posted Date: 2026-08-04T15:16:09.484+00
Request Type: modify
Cancel Notice: 0
Archive Notice: 0
Opportunity Id: 2021ed1c024b4cd1a754c90cf3456d24
Procurement Type: k
Solicitation Number: 2026-Q-97423
Parent Opportunity Id: bf06fe9f725e473d9aac9269e46d5301

Index: 1
Title: Clinical Trial Management System for TB Clinical Research
Latest: 0
Deleted: 0
Action Date: 2026-07-31T07:57:04.951+00
Action Type: publish
Posted Date: 2026-07-31T07:57:04.948+00
Request Type: submit
Cancel Notice: 0
Archive Notice: 0
Opportunity Id: bf06fe9f725e473d9aac9269e46d5301
Procurement Type: k
Solicitation Number: 2026-Q-97423

Base Type

Combined Synopsis/Solicitation

Notice Id

2021ed1c024b4cd1a754c90cf3456d24

Naics Code

54151

Resources

Attachments

Name: "Questions_Answers Worksheet.xlsx"
Size: 14043
Type: "file"
Mime Type: ".xlsx"
File Exists: "1"
Posted Date: "2026-08-04T15:16:09.484+00:00"
Resource Id: "135aec508a8a4c72b0cf5711b737741a"
Access Level: "public"
Deleted Flag: "0"
Access Status: "public"
Attachment Id: "4fe3280b8a3d4e058ceab7075c229c42"
Explicit Access: "0"
Attachment Order: 9
Export Controlled: "0"

Name: "SOL-75D30126Q79181 DB.pdf"
Size: 574261
Type: "file"
Mime Type: ".pdf"
File Exists: "1"
Posted Date: "2026-07-31T07:57:04.948+00:00"
Resource Id: "86a5688fe6124bc68be92b38f2f97878"
Access Level: "public"
Deleted Flag: "0"
Access Status: "public"
Attachment Id: "750ebe04860d41abbb28338a8112bf68"
Explicit Access: "0"
Attachment Order: 8
Export Controlled: "0"

Name: "RFP-CLINICAL TRIAL MANAGEMENT SYSTEM-FE.pdf"
Size: 147979
Type: "file"
Mime Type: ".pdf"
File Exists: "1"
Posted Date: "2026-07-31T07:57:04.948+00:00"
Resource Id: "f222a0811f0f4ebc83fbe8ea872b9f54"
Access Level: "public"
Deleted Flag: "0"
Access Status: "public"
Attachment Id: "7a1d621c6cb3403097b828cc905290ac"
Explicit Access: "0"
Attachment Order: 7
Export Controlled: "0"

Name: "AI Use Compliance and Risk Attch 5.pdf"
Size: 122593
Type: "file"
Mime Type: ".pdf"
File Exists: "1"
Posted Date: "2026-07-31T07:57:04.948+00:00"
Resource Id: "152a343ffda842849be68b164643bbb0"
Access Level: "public"
Deleted Flag: "0"
Access Status: "public"
Attachment Id: "abe3893340b14a9ebb80b634fdb5ae74"
Explicit Access: "0"
Attachment Order: 6
Export Controlled: "0"

Name: "CTMS questions Attachment 4_.pdf"
Size: 111151
Type: "file"
Mime Type: ".pdf"
File Exists: "1"
Posted Date: "2026-07-31T07:57:04.948+00:00"
Resource Id: "f27726d841c84c75b0540d90ecf386d7"
Access Level: "public"
Deleted Flag: "0"
Access Status: "public"
Attachment Id: "4801dc4a22fb4abc975245ab88173233"
Explicit Access: "0"
Attachment Order: 5
Export Controlled: "0"

Name: "VPAT Report- Attachment 6.docx"
Size: 53243
Type: "file"
Mime Type: ".docx"
File Exists: "1"
Posted Date: "2026-07-31T07:57:04.948+00:00"
Resource Id: "5f8cc8f00fba419b9e0169b842784cb7"
Access Level: "public"
Deleted Flag: "0"
Access Status: "public"
Attachment Id: "43e3edd974b94adb9b26f05d61b0be29"
Explicit Access: "0"
Attachment Order: 4
Export Controlled: "0"

Name: "Pricing Schedule Attachment 2-.xlsx"
Size: 47405
Type: "file"
Mime Type: ".xlsx"
File Exists: "1"
Posted Date: "2026-07-31T07:57:04.948+00:00"
Resource Id: "cdbb4725c5b34b08ace63310a6444db1"
Access Level: "public"
Deleted Flag: "0"
Access Status: "public"
Attachment Id: "55fc5708f2804121afea2beb4d05cb0e"
Explicit Access: "0"
Attachment Order: 3
Export Controlled: "0"

Name: "Letter of Supply Template Attachment 3.docx"
Size: 21410
Type: "file"
Mime Type: ".docx"
File Exists: "1"
Posted Date: "2026-07-31T07:57:04.948+00:00"
Resource Id: "372e79039f734e08954062b53b117e7f"
Access Level: "public"
Deleted Flag: "0"
Access Status: "public"
Attachment Id: "edfa9e215fe943118042184f4fe457ab"
Explicit Access: "0"
Attachment Order: 2
Export Controlled: "0"

Name: "Attachment 1 SOW crosswalk.docx"
Size: 19784
Type: "file"
Mime Type: ".docx"
File Exists: "1"
Posted Date: "2026-07-31T07:57:04.948+00:00"
Resource Id: "5a25070c9f934eb5953b19551512379c"
Access Level: "public"
Deleted Flag: "0"
Access Status: "public"
Attachment Id: "53bbce8fc10b4ee7a458677f9f8735ab"
Explicit Access: "0"
Attachment Order: 1
Export Controlled: "0"

Opportunity Id

2021ed1c024b4cd1a754c90cf3456d24

Department

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Posted Date

Aug 4, 2026

Detail Fetched

Yes

Resource Links

History Fetched

Yes

Point Of Contact

Type: primary
Email: xvv9@cdc.gov
Full Name: Debra Baker

Type: secondary
Email: vyh1@cdc.gov
Full Name: Liubov Kriel

Description Text

The Center for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Division of Tuberculosis Elimination (DTBE) Clinical Research Branch (CRB) intends to award a purchase order to purchase a software as a service clinical trial management system (CTMS) to plan, manage, and track clinical trial documents throughout the lifespan of a TB clinical trial for the TB Trials Consortium (TBTC). This acquisition is unrestricted (Full and Open) This competitive acquisition is conducted under the streamlined ordering procedures of Federal Acquisition Regulation (FAR) 12.6 and (FAR) 5.203. **(i)** This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement contains the only solicitation; proposals are being requested and a written solicitation will not be issued later. **(ii)** Solicitation number **75D30126Q79181** is issued as a Request for Quote (RFQ). **(iii)** The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) **2026-01**. **(iv)** This acquisition is **Unrestricted (Full and Open Competition)**. The associated North American Industry Classification System (NAICS) code is **513210 (Software Publishers)**,541511 and the small business size standard is **$47.0 Million**. Inquiries shall be sent to Debra Baker by email at vxvv9@cdc.gov and reference solicitation #2026-Q-97423 and title on the subject line.

Resources Fetched

Yes

Response Dead Line

Aug 14, 2026

Full Parent Path Name

DEPARTMENT OF HEALTH AND HUMAN SERVICES.CENTERS FOR DISEASE CONTROL AND PREVENTION.CDC OFFICE OF ACQUISITION SERVICES

Place Of Performance

Zip

30333

City

Code: 4000
Name: Atlanta

State

Code: GA
Name: Georgia

Country

Code: USA
Name: UNITED STATES

Solicitation Number

2026-Q-97423

Not the right RFP for you?

Open opportunities in the same trade and area, with time left to bid

See all Health & Medical Research bids →

Professional & Consulting ServicesFederal · SAM.govFederal Advisory Committee Meeting ServicesDepartment of Health and Human Services · Atlanta, GAAug 2413 days left Professional & Consulting ServicesFederal · SAM.govUS Embassy Tbilisi American Spaces Procurement /Financial Administration ServicesDepartment of State · GeorgiaAug 3120 days left Professional & Consulting ServicesGeorgiaOn-Call Traffic Control ServiceGeorgia World Congress Center Authority · GeorgiaSep 0424 days left Professional & Consulting ServicesFederal · SAM.govRegional Innovation ClustersGeneral Services Administration · GeorgiaAug 2413 days left

Let our AI help you find the right opportunitySearch with AI →

Source: SAM.gov (notice 2021ed1c024b4cd1a754c90cf3456d24), retrieved via the SAM.gov Get Opportunities API. View the official posting , always confirm requirements and deadlines with the issuing agency.

Federal · SAM.gov · Atlanta, GA

Clinical Trial Management System for TB Clinical Research

Department of Health and Human ServicesIssuing agency·Atlanta, GA·via the SAM.gov Get Opportunities API

3days left

Due Aug 14, 2026·Posted Aug 4, 2026

AI takeaways

The CDC is procuring a cloud-based Clinical Trial Management System (CTMS) to plan, manage, and track clinical trial documents for TB clinical research, to be performed in Atlanta, GA.
Proposals are due August 14, 2026, at 2:00 PM EDT, with a base period of September 1, 2026 through August 31, 2027, plus two 12-month option periods.
The solicitation number is 75D30126Q79181, issued as a Request for Quote (RFQ) under FAR 12.6, unrestricted (full and open competition).
The CTMS must be 21 CFR Part 11 compliant, include role-based access for up to 20 CDC users, 22 trial site accounts, and 50 eISF portal users, and integrate with CDC SAMS and EDC systems.
The contractor must obtain and maintain FedRAMP Low-risk authorization and undergo annual 3PAO assessments.
Questions must be submitted in writing by August 7, 2026, via email to Debra Baker at xvv9@cdc.gov.
The issuing agency is the Department of Health and Human Services, Centers for Disease Control and Prevention.
Requirement: The contractor shall obtain and maintain a FedRAMP authorization at the Low-risk level for the entirety of the contract’s duration.

Term: 12-month base period…
Method: Combined Synopsis/Solicitati…
Documents: 9 files

These takeaways are AI-generated and may be incomplete or wrong. Always verify every detail against the official documents before you bid.

Contact the buyer

Debra Baker

xvv9@cdc.govEmail

Location:

Atlanta, GA 30333

Open in Maps ↗

Notice

2021ed1c024b4cd1a754c90cf3456d24

2026-Q-97423

Method

Combined Synopsis/Solicitation

Duration

12-month base period starting September 1, 2026, with two (2) subsequent 12-month option periods

More health & medical research bids in Georgia, weekly.

We post new health & medical research opportunities in Georgia as agencies publish them. Get them in one email — free, and unsubscribe whenever.

What this bid is asking for

AI-generated

Provide a 21 CFR Part 11 compliant, web-based CTMS with role-based access for up to 20 CDC users, 22 trial site accounts, and 50 eISF portal users.
Integrate the CTMS with CDC's Secure Access Management Services (SAMS) and existing Electronic Data Capture (EDC) system.
Obtain and maintain FedRAMP Low-risk authorization, including annual 3PAO assessments and continuous vulnerability monitoring.
Deliver a configuration and onboarding plan executed within 15–50 days of award, including user acceptance testing and training.
Submit a quotation split into three volumes: Technical Approach & Software Capabilities, Past Performance, and Price Proposal.

Posted Scope of Work

This competitive acquisition is conducted under the streamlined ordering procedures of Federal Acquisition Regulation (FAR) 12.6 and (FAR) 5.203.

(ii) Solicitation number 75D30126Q79181 is issued as a Request for Quote (RFQ).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-01.

Inquiries shall be sent to Debra Baker by email at vxvv9@cdc.gov and reference solicitation #2026-Q-97423 and title on the subject line.

Scope, read from the documentsAI-generated

Questions & answers

AI-generated

What is the due date for proposals?

Proposals must be submitted electronically via email no later than August 14, 2026, at 2:00 PM EDT.

Who is the contracting officer and how do I submit questions?

Questions must be submitted in writing using the provided Q&A template by August 7, 2026 via email to the Contracting Officer, Debra Baker at xvv9@cdc.gov.

What is the period of performance?

The period of performance is a 12-month base period starting September 1, 2026, with two subsequent 12-month option periods, through August 31, 2029.

What security compliance is required?

The contractor shall obtain and maintain a FedRAMP authorization at the Low-risk level for the entirety of the contract’s duration.

Documents

Download zip

Questions_Answers Worksheet.xlsxXLSX

Preview Download

SOL-75D30126Q79181 DB.pdfPDF

Preview Download

RFP-CLINICAL TRIAL MANAGEMENT SYSTEM-FE.pdfPDF

Preview Download

AI Use Compliance and Risk Attch 5.pdfPDF

Preview Download

CTMS questions Attachment 4_.pdfPDF

Preview Download

VPAT Report- Attachment 6.docxDOCX

Preview Download

Pricing Schedule Attachment 2-.xlsxXLSX

Preview Download

Letter of Supply Template Attachment 3.docxDOCX

Preview Download

Attachment 1 SOW crosswalk.docxDOCX

Preview Download

Full source recordEvery field SAM.gov published, untouched

Hit

2021ed1c024b4cd1a754c90cf3456d24

Type

Code: k
Value: Combined Synopsis/Solicitation

Type

opportunity

Award

Awardee

Title

Clinical Trial Management System for TB Clinical Research

R Score

Is Active

Yes

Is Canceled

Publish Date

Aug 4, 2026

Descriptions

Content: <p>The Center for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Division of Tuberculosis Elimination (DTBE) Clinical Research Branch (CRB) intends to award a purchase order to purchas
Last Modified Date: Aug 4, 2026

Modified Date

Aug 4, 2026

Response Date

Aug 14, 2026

Modifications

Count: 1

Parent Notice Id

bf06fe9f725e473d9aac9269e46d5301

Response Time Zone

America/New_York

Response Date Actual

Aug 14, 2026

Solicitation Number

2026-Q-97423

Organization Hierarchy

Code

7500

Name

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Type

DEPARTMENT

Level

Status

active

Address

Zip: "20201"
City: "Washington"
State: "DC"
Country: "US"
Street Address: "Hubert H. Humphrey Building 200 Independence Avenue, SW "

Organization Id

100004222

Code

7523

Name

CENTERS FOR DISEASE CONTROL AND PREVENTION

Type

AGENCY

Level

Status

active

Address

Zip: "30333"
City: "Atlanta"
State: "GA"
Country: "US"
Street Address: "1600 Clifton Road"

Organization Id

100007448

Code

75D301

Name

CDC OFFICE OF ACQUISITION SERVICES

Type

OFFICE

Level

Status

active

Address

Zip: "30333"
City: "ATLANTA"
State: "GA"
Country: "USA"
Street Address: "1600 CLIFTON ROAD"

Organization Id

100188028

Type

Combined Synopsis/Solicitation

Title

Clinical Trial Management System for TB Clinical Research

Active

Yes

Detail

Type

Naics

Code: 54151
Type: primary

Title

Clinical Trial Management System for TB Clinical Research

Not the right RFP for you?

Open opportunities in the same trade and area, with time left to bid

See all Health & Medical Research bids →

Let our AI help you find the right opportunitySearch with AI →