Sitero, a clinical research and technology company, has released three agentic workflows for Ash, its clinical AI agent: Ash for Study Configuration, Ash for Data Management and Ash for Insights. The release spans the full clinical data lifecycle, from the earliest stage of study configuration through ongoing data review and portfolio-level risk visibility.
“Clinical teams don’t need another AI tool layered on top of their systems. They need AI that works from a single, trusted view of their study data and leaves a traceable record at every step. That’s what Ash delivers,” said Sitero CEO Sankesh Abbhi.
Sitero’s clinical intelligence engine SiteroAI underlies all three workflows. SiteroAI continuously ingests and harmonises data from across the clinical ecosystem, including EDC, IRT/RTSM, central and local labs, ePRO, safety databases and third-party vendor feeds, into a single, governed data layer.
Ash operates directly on SiteroAI. Rather than connecting AI to siloed systems one at a time, SiteroAI provides a consistent data foundation that makes Ash more accurate, more contextual and easier to govern.
Ash for study configuration
Ash for study configuration enables clinical teams to take protocol from upload to a fully configured, live study in two weeks, compared to the months-long specification cycles of traditional approaches.
Teams upload a protocol and receive a structured study draft, including the study tree, visits, forms, fields, code lists, and edit checks, all drawn from SiteroAI’s protocol and standards libraries.
Ash for study configuration also manages the full study setup and change lifecycle. Specification documents are house in integrated eBinders, keeping all configuration artifacts, including annotated CRFs, edit check specs, data management plans, and amendment histories, organised, versioned, and audit-ready in a single location. eSignature workflows allow qualified team members to review and sign off on specifications electronically.
When a protocol amendment or study change is initiated, Ash identifies the downstream impact across the study build, routes updated specs for review and signature, and updates the eBinder, compressing what has historically been a weeks-long change management process into days.
Ash for data management
Ash for data management provides continuous data review, query management, and vendor reconciliation through two integrated capabilities. The DM Workbench gives data managers a single, role-based workspace where reviews are auto-assigned based on data type, therapeutic area, and team structure. Ash surfaces only relevant data issues to each team member
Ash for insights
Ash for Insights provides study and portfolio-level dashboards with database lock forecasting. Teams can track clean patient status, query trends, and lock readiness continuously throughout the study rather than at the point of lock.
