Electronic Trial Master File Solution
- Client
- —
- RFP Number
- SW-120514
- Posted
- 10/8/2026
- Category
- Software, System and Application
- Budget
- Looking for Proposals
- NAICS
- —
- Set-aside
- —
- Contact
- —
Description
AI GeneratedCOG Research Foundation, LLC seeks a vendor to provide a secure, compliant electronic Trial Master File (eTMF) solution and associated services for offsite performance. The requested scope includes supporting the management, maintenance, oversight, and archival of clinical trial documentation through document lifecycle management, configurable workflows, audit trails, electronic signatures, and reporting capabilities. World-wide vendors registered in SAM.gov with relevant experience and references are eligible to bid. Bidders must submit proposals digitally via email or online by 12:00 AM on October 16, 2026, with clarifying questions due by 12:00 AM on October 9, 2026. Submissions must include qualifications, key personnel backgrounds, an itemized cost proposal, an estimated schedule, and disclosures of potential conflicts of interest. Evaluation criteria encompass technical capabilities, personnel experience, past performance, and total cost and value.
Key solicitation details
AI-extracted from Request-for-Proposals-electronic-Trial-Master-File-eTMF-and-services.pdf. Confirm against the original documents before bidding.
COG Research Foundation, LLC is seeking proposals from qualified vendors to provide a secure, compliant, and user-friendly Electronic Trial Master File (eTMF) platform and associated services. The solution will support clinical trial document management, oversight, and archival. Qualified SAM.gov registered vendors with relevant experience are eligible to bid.
- Issued by
- COG Research Foundation, LLC
- Clarifying questions due
- 10/9/2026 12:00 AM
- Proposals due
- 10/16/2026 12:00 AM
- How to submit
- Submission details
- Submit proposals to Harley Ding via email. Proposals must be a maximum of 8 pages, excluding appendices, samples, or references.
- Place of performance
- Offsite
- Funding
- 2 CFR Part 200
How proposals are evaluated
| Understanding of and approach to the Scope of Work | |
| Experience and qualifications of proposed personnel | |
| Past performance on similar projects | |
| Total cost and overall value |
Scope of work
- Electronic Trial Master File platform
- Implementation and support services
- Creation and maintenance of electronic Trial Master Files
- Organization of documents according to TMF reference model
- Study and site documentation management
- Configurable workflows
- Reporting and dashboards for oversight and inspection readiness
- Integration with Medidata products such as CTMS
Minimum qualifications
- Must be a SAM.gov registered vendor
- Demonstrate relevant experience with projects of similar scope and complexity
- Provide references from previous clients upon request
Documents to include with the bid
- Consultant/Organization Profile
- Qualifications and Experience description
- Identification and background of key personnel
- Detailed cost proposal with itemized breakdown of fees, taxes, and expenses
- Timeline and estimated schedule for deliverables
- Conflict of interest disclosure
Verify important details
Document checkConfirm submission instructions and amendments with the issuing agency before responding.
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