A19 - RFQ_75D301-23-Q-77070 Amendment 00001 QandA Attachment 1.docx
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- TBTC Clinical Trial Management System
- Solicitation number
- 75D301-23-Q-77070
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This document contains questions and answers regarding Solicitation Number 75D301-23-Q-77070 from the Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services for a TBTC Clinical Trial Management System. The solicitation seeks proposals for a new clinical trial management system contract to manage two clinical trials involving tuberculosis infection and disease. The incumbent currently provides some trial management services under a separate IT contract but the new contract will cover all services listed, including building two clinical trials with 19 and 25 case report forms and an estimated 600 and 50 enrollments respectively, with the ability to provide medical coding preferred. Offerors may propose alternative milestone schedules. No incumbent, estimated budget, or preferred systems were identified.
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| File | Type | Posted |
|---|---|---|
| A19 - RFQ_75D301-23-Q-77070 Amendment 00002.doc | DOC document | |
| A19 - RFQ_75D301-23-Q-77070 Amendment 00001.doc | DOC document | |
| RFQ_75D301-23-Q-77070_CSS.doc | DOC document |
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QUESTIONS AND ANSWERS
Solicitation No. 75D301-23-Q-77070, Amendment 00001 Attachment TBTC Clinical Trial Management System
1. Is this a brand new contract, or is there an incumbent performing these services? If not brand new, could you please provide the current/previous contract number?
This is a new contract. There is an incumbent performing trial management services, but all services listed in the new contract are not provided by the incumbent.
2. In reference to page 4, Sections 3 and 4, Scope of Work and Tasks to be Performed paragraphs, what language or languages is required for the clinical trial management system, training, and all other materials?
All materials will be in English.
3. Does the solution require a medical coding module?
The ability to provide MedDRA coding is preferred.
4. There are also 2 studies to build and migrations. There are no details on either in order to quote. Are there more details on that?
Study #1 has 19 case report forms, with 14 sites open for enrollment, and an estimated 600 enrollments at the time of migration. The trial is listed here: https://clinicaltrials.gov/study/NCT03474029?term=TBTC&cond=Tuberculosis%20Infection&limit=100&page=1&rank=24
Study #2 has 25 case report forms, with 13 sites enrolling, and an estimated 50 enrollments at the time of migration. The trial is listed here: https://clinicaltrials.gov/study/NCT05766267?term=TBTC&cond=Tuberculosis&limit=100&rank=5
5. Does the government have a preferred clinical trial management system (CTMS) or systems under consideration? If so, can you please share what they are?
No.
6. Can the vendor propose a milestone schedule different from the schedule set forth by the government.
Yes, the offeror can propose a different milestone schedule.
7. Is there an incumbent performing some or all of this work and if so, who is the vendor and what is the contract number?
Currently an incumbent is performing some of this work. This contract is new and will cover all work listed. The incumbent is part of a larger IT contract at CDC.
8. Can the government provide their independent estimate by LCAT and hours for this contract?
No, we are not able to provide an estimate by LCAT and hours for this contract.
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