Digital Co-Workers.
Delivered.
Purpose-built agents for DM, RBQM, and Stats. Here's a sampling of our most popular Agentic AI use cases.
Agentic Data Standardization
Today's studies pull data from everywhere — EDC, labs, eCOA, imaging, wearables, vendors, and third-party systems.
Our Agentic Data Standardization capability automatically maps, transforms, and harmonizes raw source data into CDISC-aligned, analytics-ready structures.
-
Auto-mapping to SDTM & ADaM domains
-
Intelligent detection of data changes and unmapped fields
-
Recommendations for controlled terminology alignment
-
Continuous synchronization as new data arrives
Impact
Teams move from weeks of manual standardization to fully mapped data in as little as a day.
Agentic Data Validation Plan Creation
Creating a Data Validation Plan is typically slow, inconsistent, and heavily manual. It starts with a deep dive into your protocol and study design specs, and ends with 200–400 conditional rules — each with custom logic, and site-facing query messages.
Our Data Validation Plan Agent redefines this process. Watch as the Agent uses an uploaded protocol & CRF metadata to build an entire Data Check Plan automatically. It applies logic from the protocol, and pulls relevant checks from our OOTB library to generate an executable plan in minutes.
And it doesn’t stop there — the agent even writes the code for checks in JavaScript, Python, or R.
-
Save hundreds of man-hours and several weeks in your timeline
-
Generates edit checks, and quality checks across forms
-
Remain in control with HITL quality checks
-
Outputs a structured, version-controlled DVP ready for review & approval
Impact
Slash data check creation by 75% and accelerate database build timelines.
Agentic Risk Review
Risk review can be difficult to operationalize — disparate systems, delayed insights, and inconsistent review processes.
Our Agentic Risk Review monitors triggered KRIs and Risk alerts and provides a detailed analysis of the data contributing to the breach along with recommended actions, saving Central Monitors valuable time.
-
Monitors KRIs/KPIs, metrics and operational data across sources
-
Surfaces anomalies and performs root-cause-analysis for threshold breaches
-
Recommends controls and follow-up actions for expedited resolution
Impact
Cut KRI review time by 45% or more.
Agentic TFL Generation
Statistical programming is one of the most time-consuming steps in clinical development.
Our TFL Generation Agent interprets the SAP, maps it to ADaM structures, and autonomously produces analysis-ready tables, figures, and listings.
-
Parses SAP text, shells, and mock outputs
-
Generates ADaM derivations and TFL shells
-
Creates executable code and natural-language logic explanations
-
Produces consistent, submission-ready outputs with full lineage
Impact
Produce high-quality delivery outputs in a fraction of the time.
Klini™ - Conversational Agent
Klini™, ThoughtSphere’s always-on conversational agent, enables users to interact with clinical and operational data using natural language — turning complex data exploration into simple, on-demand insight.
With Klini™, teams can:
-
Ask natural-language questions across harmonized study data
-
Instantly retrieve metrics, trends, and patient-level insights
-
Ask questions on platform navigation, medical terminology, and operational trends
-
Understand results with transparent, explainable responses
-
Access and share prior conversations for collaboration
Impact
Klini™ delivers insights on-the-fly giving end-users the answers they need — without waiting for reports or manual analysis.
CRA Companion
CRAs access 10+ systems to assess site health and execute follow-up actions, creating complexity and high administrative burden.
The CRA Companion acts as a digital co-worker — streamlining data and tasks across systems to support site oversight, query resolution, and follow-up activities so CRAs can focus on site engagement and patient safety.
-
Auto-generates holistic analysis of site health
-
Analyzes answered CRA queries and queues for closure or re-query
-
Draft trip reports and including the current status of f/u actions from the last visit
-
Tracks upcoming SMVs, travel plans and expense reports
-
Identifies, triages, and provides recommendations for site risks
Impact
Increase Overall CRA Efficiency by >35%
Agentic Text to Code
Programming know-how has been a long-standing bottleneck in clinical development, but not anymore.
Agentic Text-to-Code enables any user to generate programming logic using natural language — accelerating derivations, mappings, and data check creation.
-
Generate transformation logic & custom derivations for mappings
-
Create data check logic using plain English instructions
-
Produce executable code in R, Python, or JavaScript
-
Reduce manual programming effort and turnaround time
-
Review and refine code with built-in workflows
Impact
Transform programming from a specialized task to multi-user functionality and eliminate process bottlenecks
Agentic Test Data Generation
Agentic Test Data Generation automatically creates realistic synthetic datasets to support testing, validation, and workflow review.
-
Generate synthetic datasets aligned to study design and metadata
-
Validate data checks, mappings, and derivations before deployment
-
Simulate edge cases and rare scenarios
-
Accelerate testing cycles without waiting for live data
-
Support audit-ready validation processes
Impact
Don’t spend hours entering test data; deliver quality checks quickly with agentic test data generation.
Enterprise-Grade AI, Built for Clinical Trials
Agentic AI is only as powerful as the ecosystem it operates in. ThoughtSphere delivers a unified, governed platform where every agent is anchored by:
Shared Metadata
Across all studies and functions
Full Data Lineage
From raw source to submission artifacts
Human-in-the-Loop
HITL oversight embedded into workflows
Role-Based Security
Permissioning and audit control
Standards-Driven
CDISC, ICH-E6(R3), ICH-M11, TransCelerate DDF
Clinical Ontology
End-to-end data lifecycle connection
This is not "AI sprinkled on top" — it's a coordinated intelligence layer powering your entire data lifecycle.
Responsible AI. Built In. Not Bolted On.
Transparency & Explainability
Data Privacy & Security
Data Integrity & Fairness
Aligned with Global AI Regulations
Committed to responsible AI governance and compliance
Ready to Deploy Your Digital Co-Workers?
See how our agentic AI can transform your clinical operations with intelligent automation and real-time insights.