WSIRB Management System

This contract provides the Washington State Institutional Review Board (WSIRB) with a cloud‑based Electronic Protocol Management System (IRBManager) and associated support services. The state will receive a fixed‑price SaaS license, ongoing system maintenance, help‑desk support, annual data archiving, and regular software updates to ensure compliance with FDA 21 CFR Part 11, 45 CFR 46, and related regulations. • Fixed‑price, five‑year term (maximum $178,925.14) with one optional five‑year renewal. • Vendor supplies the IRBManager SaaS platform, 24×7 availability, help‑desk support (8 AM–8 PM ET business days), and yearly data‑archive deliveries. • Strict data‑security requirements (AES‑256 encryption, multi‑factor authentication, audit trails, incident reporting) as detailed in Exhibit A. • No competition – sole‑source award to Biomedical Research Alliance of New York, LLC (TechSoftware). • Annual budget escalates from ~$31 k in Year 1 to ~$40 k in Year 5.