CONSHOHOCKEN, PA — Suvoda is extending its artificial intelligence assistant to all new clinical trials using its RTSM/IRT or eCOA systems, allowing pharmaceutical sponsors, contract research organizations and research sites to automate authorized operational tasks while maintaining the access controls and audit records required in regulated clinical research.
The Conshohocken-based clinical trial technology company said its Sofia assistant is now available for new studies using those systems following an initial rollout to early adopters.
The expansion moves Sofia beyond a limited deployment and integrates AI-assisted operations into Suvoda’s broader clinical trial technology platform.
Sofia allows research teams to retrieve information from live study data, review operational records and execute certain system actions through a conversational interface.
The system addresses administrative demands associated with clinical trials, including tracking investigational drug inventory, reviewing shipments, monitoring patient visits and managing questionnaire compliance across research sites.
Unlike AI tools limited to answering questions or summarizing documents, Sofia can perform actions within the Suvoda Platform on behalf of authorized users.
Before executing an action, the assistant presents a summary of the proposed operation and requests user confirmation. Completed actions are attributed to the requesting user and recorded in an audit trail.
The system operates under existing user permissions, limiting access and actions according to each individual’s authorized role.
Those controls are particularly significant in clinical trials, where changes to operational data must be traceable and access to certain study information must remain restricted to protect trial blinding.
Suvoda said Sofia uses conversational AI to interpret user requests and connect them to validated functions developed by subject matter experts.
Those functions operate against live clinical trial data within a controlled framework rather than relying solely on unrestricted language-model responses.
The assistant currently supports more than 40 operational topics, with additional capabilities under development.
“Sofia handles the routine operational work so that sponsors, CROs, and sites can focus on the decisions that require their judgment,” said E.K. Koh, Suvoda’s chief product officer.
The company developed the assistant with input from early adopters, including pharmaceutical company Daiichi Sankyo.
Dawn Sorenson, director of Daiichi Sankyo’s IRT Center of Excellence, said the system reduced the effort required to retrieve operational information and navigate multiple workflows.
“Tasks that once required multiple steps can now be addressed through a simple conversation, creating meaningful efficiency gains across study operations,” Sorenson said.
Suvoda’s RTSM/IRT technology supports randomization and trial supply management, while its eCOA systems collect electronic clinical outcome assessments.
The addition of Sofia gives users of those systems a common interface for accessing study information and completing supported operational tasks.
Suvoda said the assistant follows a zero-data-retention policy and does not use customer information to train public AI models.
It also restricts users to information they are already permitted to access within the platform, while responding in the language used to submit a question.
The broader deployment follows Sofia’s recognition in the artificial intelligence category of the PM360 Innovation Awards.
By embedding AI-assisted actions into its clinical trial systems, Suvoda is expanding the operational role of its software beyond data management and reporting while retaining human confirmation for system changes.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.