Author: Jadon Sargeant, Senior Product Owner at Suvoda
Snapshot:
- Ask instead of search: Get trial information and take action through natural conversation rather than clicking through multiple screens.
- Get reliable answers: Sofia only responds to questions it knows how to answer correctly, avoiding the guesswork of typical AI tools.
- Available on the Suvoda Platform: Sofia is now available in Suvoda RTSM/IRT and eCOA, bringing conversational support into the systems teams use to manage studies.
An AI teammate for clinical trials
Study teams deal with time-sensitive questions all day long. Where's that delayed shipment? How much inventory does Site 15 have left? What are the five patients with the lowest questionnaire compliance rate? What does the patient enrollment curve look like for Cohort B?
The information exists. It is in the system. But surfacing the right data point at the right moment often means navigating multiple screens, pulling reports, or taking more time than it needs to. For sponsors, CROs, and sites operating across time zones and roles, that friction compounds.
Sofia changes the experience. Rather than searching for answers, teams can ask for them. Sofia is the AI assistant on the Suvoda Platform, designed to give sponsors, CROs, and sites faster, smarter access to trial data and the ability to act on it through a natural language interface built for the demands of regulated clinical research.
How Sofia works
Some AI tools in the market apply a large language model to a problem and hope the output is accurate. Sofia is built differently.
Suvoda's clinical trial subject matter experts author a curated knowledge space. This is a set of questions with corresponding expert instructions that define, step by step, how each question should be answered. Sofia does not improvise. It does not generate plausible-sounding answers and present them as fact. It follows verified, tested instructions.
When Sofia can answer a question, it does so. When it cannot, it says so clearly rather than filling the gap with something unreliable. Today, Sofia's knowledge space spans 40+ topics, developed with the same rigor Suvoda applies to every product it builds.
Built to give reliable answers
Every question in Sofia's knowledge space goes through Suvoda's full Software Development Lifecycle before release. This is the same development and validation process applied to Suvoda RTSM, Suvoda eCOA, and every other product on the platform.
Each question is tested multiple times with different trial data to verify consistent, reliable performance. Suvoda’s team validates that Sofia follows instructions correctly and pulls the right information from trial systems. Sofia also shows its work. When teams want to verify an answer or understand how Sofia found something, they can review the steps Sofia took.
Sofia is AI that reflects deep clinical trial expertise, not a general-purpose model adapted for a regulated environment. In a clinical trial, a wrong answer is not just unhelpful. It can carry human, operational, and compliance risk.
Taking action, not just answering questions
Sofia's role goes beyond information retrieval. For authorized users in RTSM/IRT, Sofia can execute system actions on their behalf, turning what previously required navigating multiple screens and working through multi-step processes into a single conversation.
Before executing any action, Sofia summarizes exactly what it is about to do and asks the user to confirm. Every action is attributed to the person who requested it and governed by the same roles and permissions framework that controls direct access in the Suvoda Platform. If a user is not authorized to perform an action directly in the system, Sofia cannot perform it on their behalf.
Once complete, every action is captured in a full audit trail, making it straightforward to identify who took action and when.
Security and privacy designed in from the start
Sofia is scoped precisely to what each user is already authorized to see. The AI layer introduces no elevated access. Data permissions carry over directly from the existing roles and permissions framework in the Suvoda Platform.
Sofia has a zero-day data retention policy. Data is used only to answer the active query and is not retained afterward. It is never used to train public models. Conversation history is stored within Suvoda's audit trail, not in an external AI database, providing full traceability consistent with the requirements of regulated research. There is no new data governance model to validate. Everything already in place carries over.
Global language support
Sofia supports global operations by responding in the language of the question. When someone asks a question in Spanish, Sofia responds in Spanish. When the query comes in German, the answer appears in German. For international sponsor, CRO, and site teams working across time zones and roles, this removes one more point of friction.
Expanding across the Suvoda Platform
Sofia is now generally available for new studies on Suvoda RTSM and Suvoda eCOA, giving drug supply managers, clinical teams, and site staff the same conversational access to trial data through a single, consistent interface.
Looking further ahead, Sofia is being built toward monitoring, alerting, and proactive decision support: not just answering questions, but surfacing what should be asked before it becomes a problem. As Sofia's knowledge space expands across the full Suvoda Platform, it becomes an assistant across every product, every user, and every mission-critical moment.
“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.”
Running smoother clinical trials starts with better access to information
Clinical trials are complex by nature. The data to manage them well exists, but the ability to reach it quickly and act on it with confidence has historically required more effort than it should. Sofia represents a different approach. Rather than adapting a general-purpose model for a regulated environment, Suvoda built an AI assistant from the ground up for the specific demands of clinical research, developed by people who understand that in clinical trials, there is no room for error.
Authors
Jadon Sargeant
Senior Product Owner, Suvoda
SOFIA
Sofia. Your AI assistant for clinical trials
- Gives sponsors, CROs, and site teams faster access to data
- Easy to use and purpose built for regulated research
- Capable- 70+ agentic capabilities where Sofia can take action
- Secure- 0-data data retention policy
- Knowledgeable- 40+ topics in Sofia's clinical trial knowledge space
