Biostatistical Software

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.