• Clinical trials require guard railed AI that's purpose built for the regulated industry that has high human stakes and required audit trails.
• Sofia helps make complex, fast-moving trial data more accessible to study teams who manage large volumes of time-sensitive work.
• Study teams can get faster answers and take confident action. Sofia goes beyond information retrieval and can execute authorized system actions on behalf of busy users while maintaining the permissions and audit trails required in clinical trials.

Suvoda, a global clinical trial technology company, announced that Sofia, its AI assistant on the Suvoda Platform, is ready for all new clinical trials using Suvoda RTSM/IRT or Suvoda eCOA. Sofia gives sponsors, CROs, and sites faster access to trial data and the ability to act on it—through AI built for regulated clinical research.

Clinical trial teams manage high volumes of time-sensitive work. They track drug inventory, review shipment details, monitor patient visit schedules, and manage questionnaire compliance across global sites. Checking those data streams can pull attention away from patients and judgment-intensive decisions. Sofia is designed to change that equation. The goal is to make complex, fast-moving trial data more accessible so teams can focus their attention where human expertise matters most.

Sofia launched first with early adopter companies that helped shape it before today's expansion to all new Suvoda RTSM/IRT and eCOA trials.

"As an early adopter, we were impressed by how quickly our teams incorporated Sofia into their daily workflow," said Dawn Sorenson, Director, IRT Center of Excellence, Daiichi Sankyo. "The platform's ability to summarize documentation and answer operational questions makes information more accessible and reduces the time spent navigating systems or pulling reports. Tasks that once required multiple steps can now be addressed through a simple conversation, creating meaningful efficiency gains across study operations."

Built differently than general-purpose AI

Some AI tools apply a large language model to a problem and hope the output is accurate. Sofia is built differently. Conversational AI maps each question's intent to Suvoda's validated knowledge space, where subject matter experts have translated expert guidance into validated skills. Those skills execute against live study data within a governed framework that protects the study blind and creates the audit trail clinical trials require. Today, Sofia supports more than 40 topics and is expanding continuously.

From information to action

Sofia does not stop with just answering questions. For authorized users, Sofia can execute system actions on their behalf in a single conversation. Before acting, Sofia summarizes what it will do and asks for confirmation. Every action is attributed to the requesting user, governed by existing roles and permissions, and captured in a full audit trail.

Sofia recently received the PM360 Innovation Award in the Artificial Intelligence category, reflecting the pragmatic yet innovative approach Suvoda took to create Sofia. Early adopters were instrumental to creating a system that really works for what study teams need.