Agentic AI for clinical trials & eTMF
Most trials are behind before the first participant enrolls. Yours doesn't have to be.
You know the pattern. Startup slips a week at a time. The work is spread across a dozen tools that don't talk to each other. Data managers are still closing queries at midnight, and the month before an inspection turns into a scramble. It doesn't have to run that way. NeogeniQS builds the study, keeps the data clean, and files the TMF as you go, with your team reviewing and signing off at every step.
No sales pitch. Straight answers, including the current limits and what's on the roadmap.
Built to 21 CFR Part 11 · ICH E6(R3) · CDISC (CDASH · SDTM · ADaM) · ISO 42001
- Phase II
- Phase III
- Phase IV
- Drugs
- Biologics
- Medical Devices
Designed for end-to-end clinical development, from emerging efficacy signals and pivotal trials through regulatory submission, approval, and post-market commitments, for drug, biologic, and device studies under US FDA and EU MDR.
Start where you are
Whatever your role in the trial, start here
Every function feels the strain differently. Tell us where you sit and we'll show you the specific work NeogeniQS takes off your plate, and the agents that do it.
Sound familiar?
You're asked to move faster every cycle, with the same team and no room for a single audit finding.
- Startup drags. Getting from an approved protocol to a built, ready-to-run database still eats months you don't have.
- The work is scattered across a dozen systems that don't talk, so your team re-keys the same data and reconciles it by hand.
- The query backlog never fully clears. Someone is always closing discrepancies at 11pm before a data cut.
- And every study ends the same way, with a six-week scramble to find missing TMF documents before the inspector arrives.
And the part no one says out loud:
- An inspector opens the one zone where a filing slipped, and your name is on it.
- The only fix anyone offers is headcount you'll never get signed off.
It doesn't have to be this way
Walk in already ready.
NeogeniQS takes on the repetitive build-and-file work so your experts spend their time on judgment instead of busywork. Every output is grounded in your own documents, aligned to the standards, and signed off by a person before it counts.
- Study startup in weeks instead of quarters, with the controls fully intact.
- A Trial Master File that stays inspection-ready as you work, not one you rebuild the night before.
- Your people review and approve every step. The AI never has the last word.
One platform, end to end
One platform, from protocol to submission
Most tools own a single slice of the trial and hand you back the seams to reconcile. NeogeniQS runs the entire chain as one coordinated set of agents, so nothing falls between systems and the file is ready at any moment.
- Protocol Creator
Interprets the approved protocol and generates the study build: eCRFs, informed-consent forms, edit checks, and SDTM-annotated design.
- Takes
- Approved protocol
- Produces
- eCRF, ICF, EDC build, SDTM map
- Hands to
- Data Entry & Design
- Data Entry
Captures data into the EDC/CRF, pulls values from source documents, and drives query generation and resolution toward a clean, locked database.
- Takes
- eCRF forms, source docs
- Produces
- Clean, query-resolved data
- Hands to
- Monitoring & Biostatistics
- Monitoring
Runs risk-based monitoring under ICH E6: key risk indicators, quality tolerance limits, centralized review, and reduced source-data verification.
- Takes
- Site data, queries, KRIs
- Produces
- Risk signals, monitoring reports
- Hands to
- Project Manager & eTMF
- Biostatistics
Transforms locked data into SDTM and ADaM datasets, then programs the tables, listings, and figures behind the statistical analysis plan.
- Takes
- Clean SDTM-ready data
- Produces
- ADaM datasets, TLFs
- Hands to
- Medical Writer
- Medical Writer
Turns TLFs and clinical interpretation into regulated documents: the clinical study report, participant narratives, and submission summaries (ICH E3).
- Takes
- TLFs, ADaM, interpretation
- Produces
- CSR, narratives, SAP
- Hands to
- Document Manager
- Document Manager
Files every artifact into the electronic Trial Master File, runs QC and version control, and keeps the study continuously inspection-ready.
- Takes
- Docs from all functions
- Produces
- QC'd, complete eTMF
- Hands to
- Regulatory submission
- Project Managerorchestrates all seven
Owns the operational plan in the CTMS: timelines, budget, vendors, and cross-functional coordination from protocol approval through database lock and close-out.
- Takes
- Status from every agent
- Produces
- Milestones, risk escalation
- Hands to
- All seven agents
What changes for your team
Get the months back without loosening a control
The work that swallows startup, data management, and reporting becomes agent-driven and grounded in your documents, reviewed by your people at every step. Speed stops costing you the audit trail.
- 0%
- less time from protocol to a built, ready-to-run database· target
- 0
- AI agents across the full trial lifecycle
- 0+
- languages for informed consent and site materials
- 0
- TMF artifacts filed across 11 reference-model zones
Start where it hurts most
Whatever is slowing the study, there's an agent for it
Building the study, wrangling the data, running the analysis and reporting, or operating and archiving: each stage has a dedicated suite of agents that takes the weight off, one job at a time.
Why NeogeniQS
End-to-end and agentic, not another point tool
Incumbents sell you a system of record or a single AI feature. NeogeniQS runs the whole trial with agents that do the work, keep people in control, and stay inspection-ready, including the statistics and submission back end that nobody else automates.
| Capability | NeogeniQS | eTMF / EDC incumbents | Point AI tools | DCT platforms |
|---|---|---|---|---|
| End to end, protocol → submission in one platform | ||||
| Agentic AI that does the work, not just recommends it | ||||
| Statistical + CSR submission back-end (SDTM/ADaM/TLF, CSR) | ||||
| Continuous, one-click inspection-readiness | ||||
| Humans in control of grounded, traceable, reviewed output | ||||
| Right-sized for emerging biotech & sites |
Comparison reflects common capabilities of each category as of 2026; individual vendors vary. See our market analysis for detail.
A few of the 37 agents
Hand off the jobs that eat your week
Each agent owns one job in the trial lifecycle. Start with the task that hurts most today, or bring on the whole platform when you're ready. You set the pace.
Protocol Intelligence Agent
Digitizes any protocol and extracts its structure: objectives, eligibility, and the schedule of assessments.
Learn moreCRF Designer Agent
Turns a protocol into CDASH-compliant eCRFs with edit checks and validation rules.
Learn moreQuery Automation Agent
Runs the full query lifecycle: auto-populating responses, tracking status, and escalating by age, type, and priority.
Learn moreSDTM/ADaM Dataset Agent
Transforms raw and collected clinical data into submission-ready SDTM and ADaM datasets across all standard domains with controlled terminology applied.
Learn moreClinical Study Report (CSR) Agent
Assembles ICH E3-structured Clinical Study Reports that pull results directly from your TLFs and datasets, with full track-changes review support.
Learn moreeTMF Workflow Agent
A BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
Learn moreBuilt for regulated trials
Compliance and security by design
Every agent runs inside a validated, audit-ready platform aligned to the standards clinical teams and inspectors expect.
US FDA: Drugs, Biologics & Devices
Supports trials run under FDA IND and IDE pathways, toward NDA, BLA, 510(k), De Novo, and PMA submissions.
EU MDR 2017/745
Supports EU medical-device clinical investigations to the MDR and the ISO 14155 GCP standard, with EUDAMED-ready reporting.
21 CFR Part 11
Electronic records and signatures with full audit trails, access controls, and validation.
ICH E6(R3)
Good Clinical Practice, including risk-based quality management and computerized-system expectations.
CDISC (CDASH · SDTM · ADaM)
Standards-based data capture, tabulation, and analysis datasets that validate clean in Pinnacle 21.
HIPAA
PHI safeguards, de-identification, and role-based access across the platform, with a signed BAA for every healthcare entity we work with.
HITECH
Breach-notification and enforced-security obligations that extend HIPAA to us as your business associate.
GDPR
Lawful processing, data-subject rights, and EU data-residency support for global trials.
SOC 2
Security, availability, and confidentiality controls audited against Trust Services Criteria.
ISO 27001
Certified information-security management system governing the whole platform.
ISO 42001
AI management system for responsible, governed, and auditable use of AI.
Responsible AI · ISO 42001
You stay in control of every output, model, and sign-off
Every agent works from your source documents using retrieval-augmented generation, produces output you can trace and cite, and waits for human review and e-signature before anything is final. Our ISO 42001 AI management system governs how models are chosen, monitored, and controlled across the platform.
Fits your stack
Works with the systems you already run
Bidirectional sync keeps your EDC, IWRS/RTSM, validation tools, and document systems as the single source of truth. See all integrations →
What relief sounds like
The week you stop dreading the file
We're validating outcomes with early partners, so these reflect the workflows we build toward. Verified customer stories and quantified case studies will land here as pilots complete.
“By the time the inspection notice landed, there was nothing to scramble for: the TMF had been complete the whole way through. My nights and weekends were my own again.”
Featured resource · Whitepaper
The State of AI in Clinical Trials
Where agentic AI is delivering measurable gains across study startup, data management, biostatistics, and TMF operations and how to adopt it inside a validated, inspection-ready framework.
Whitepaper
The State of AI in Clinical Trials
Read nowFAQ
The questions decision-makers ask first
Product, compliance, security, and data, answered plainly, including the current limits and what's on the roadmap.
Bring us the study that's keeping you up
No pitch. Bring a real protocol and we'll walk through it against your timeline and compliance needs, limitations included. You'll leave knowing whether it fits, either way.