Biostatistical Software
Closed Pre-Solicitation Posted
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- Solicitation number
- PANDHA-25-P-0000012867
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 513210 Software Publishers
- Place of performance
- Frederick, Maryland 21702, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Defense Health Agency (DHA) Research & Development Medical Research & Development Command (MRDC) Office of Regulated Activities (ORA) is conducting market research to procure biostatistical software, specifically seeking Cytel's East Horizon software or an equivalent solution. The agency requires a comprehensive software suite with eight specific modules: sequential, survival, adapt, endpoints, multiarm, escalate, exact, and MAMS, designed to support clinical study designs and meet FDA regulatory standards. This Request for Information (RFI) is intended to identify commercial software solutions capable of providing advanced statistical modeling and parameter simulation for clinical research. Vendors who either sell East Software or have comparable solutions are encouraged to submit white paper responses electronically by April 23, 2025. The RFI is strictly for market research purposes and does not constitute a solicitation, with responses not being considered as binding contract offers.
The pre-solicitation notice does not indicate any specific set-aside designations for the procurement. No incumbent contractors are mentioned in the documentation, and no specific award value or budget range is disclosed. The software solution is categorized under NAICS code 513210 (Software Publishers) and PSC code 7A20 (IT and Telecom - Application Development Software). The primary point of contact for this RFI is Matthew Gembe, who can be reached at matthew.w.gembe.civ@health.mil. Submissions should be in Microsoft Word or Adobe PDF format and include a cover page with organizational details and contact information. The government emphasizes that no evaluation results will be issued to respondents, and telephonic communications will not be considered official submissions.
Notice text
Subject: The ORA of the DHA R&D - MRDC is conducting market research to for a biostatistical software (SW) solution can be provided to meet requirements for biostatical software. This market research may also assist with the further development and/or refinement of the requirements.
This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein.
This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.
Description: The ORA of the DHA R&D - MRDC has a requirement for biostatistical software - Cytel’s East Horizon software (brand name or equal – see East Software website at https://cytel.com/east-horizon/ for “salient operating characteristics). East Software Suite consisting of the modules: sequential, survival, adapt, endpoints, multiarm, escalate, exact and MAMS are requested. These modules help with study design for all the study types currently in the ORA portfolios to meet statistical requirements for effective parameter simulation to meet FDA regulatory standards.
Submission Instructions: Responses are requested from any vendors who either sells East Software or who have a SW solution with the same (equal) characteristics. As such, all capable and qualified sources are encouraged to respond to this request.
Files
| File | Type | Posted |
|---|---|---|
| B01. RFI Biostatistical Software for MRDC ORA Program Office.docx | DOCX document |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Notice of Intent to Sole Source - Cytel for East Horizon Software Platform | Special Notice | |
| This notice | Pre-Solicitation |
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