Digital Co-Workers.
Delivered.
Purpose-built agents for DM, RBQM, and Stats. Here's a sampling of our most popular Agentic AI use cases.
Impact
Teams move from weeks of manual standardization to near-instant, audit-ready outputs.
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
Agentic Data Validation Plan Creation
Creating a robust DVP to Data Check 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, site-facing query messages, and supporting documentation that needs to be created.
Our Data Validation Plan Agent redefines this process. Watch as the Agent uses an uploaded protocol to build an entire Data Check Plan automatically. It applies logic from the protocol, pulls relevant checks from our OOTB library, and generates an executable plan in minutes.
And it doesn’t stop there — if metadata such as CRF specs and vendor transfer specs are available, the agent writes the code for checks in JavaScript, Python, or R and generates synthetic data to test them.
- ✓ Save hundreds of man-hours and several weeks in your timeline
- ✓ Generates edit checks, derivations, and quality rules
- ✓ Prioritizes checks by risk impact
- ✓ Outputs a structured, version-controlled DVP ready for review
Impact
Accelerates database build, streamlines quality workflows, and eliminates redundant manual reviews.
Impact
Enables real-time RBQM instead of retrospective firefighting and saves central monitors valuable time.
Agentic Risk Review
Risk review can be difficult to operationalize — disparate systems, delayed insights, and inconsistent review processes.
Our Agentic Risk Review capability continuously evaluates study data, operational metrics, and quality signals to detect emerging risks and recommend actions.
- ✓ Monitors KRIs/KPIs, metrics and operational data across sources
- ✓ Surfaces anomalies through explainable risk logic
- ✓ Recommends controls and follow-up actions
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 specifications
- ✓ Creates executable code and natural-language logic explanations
- ✓ Produces consistent, submission-ready outputs with full lineage
Impact
Statisticians spend less time coding and more time interpreting insights.
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.