About NeogeniQS
So much of a trial's time goes not to the science but to the grind around it. Building forms, mapping datasets, chasing queries, filing thousands of documents. We started NeogeniQS to take that off your plate with agentic AI teammates that read a protocol and produce the deliverables a modern trial runs on, grounded and governed, inspection-ready, and always with your experts in control.
Our mission
Clinical trials are how new medicines reach the people who need them, and they run slower and cost more than they should. A large share of every timeline and budget goes not to the science but to manual, repeatable work: building forms, mapping datasets, chasing queries, drafting narratives, and filing thousands of documents into a Trial Master File.
NeogeniQS exists to take that work off the critical path. We build specialized AI agents that turn a protocol into a ready-to-run study, and keep it clean, documented, and inspection-ready as it runs, so clinical teams can spend their time on judgment, safety, and patients instead of keystrokes.
We are not trying to replace the people who run trials. We are trying to give data managers, biostatisticians, medical writers, clinical operations, and regulatory teams a set of tireless, standards-fluent teammates that do the first 80% and hand the last 20% to an expert for review and sign-off.
One connected platform spanning study build, data management and oversight, biostatistics and reporting, and documents, operations and support, plus RAG document intelligence and a custom clinical LLM underneath.
The agentic approach
Generative AI can draft a paragraph. Running your clinical trial takes coordinated, multi-step work that has to be traceable and auditable, with your experts accountable for every output. That gap, between a clever demo and something you could actually submit, is what we built for.
A chatbot handles one prompt at a time. Our 37 specialized agents run multi-step clinical work from start to finish, reading a protocol, building the eCRF, mapping SDTM, drafting a CSR. They coordinate through an orchestration layer, so the output of one becomes the input of the next.
Retrieval-augmented generation ties every output back to your protocol, your source documents, and the standards. Because each answer traces to a source, a regulated team can actually submit it instead of treating AI as a novelty.
Nothing is final until a qualified person reviews and e-signs it. Agents draft, reconcile, and flag the gaps; your data managers, biostatisticians, and medical writers make the call. That review model is built into every workflow, not bolted on afterward.
The platform runs inside a computerized-system-validation (CSV / GAMP 5) framework, with 21 CFR Part 11 audit trails, ISO 27001 security, and ISO 42001 AI governance. The speed you gain never costs you an audit finding.
The platform
The 37 agents are organized into four value-chain suites that mirror how a study actually moves: from protocol to build, conduct, analysis, reporting, and archive.
Turn a protocol into a ready-to-run study.
Read the protocol and build everything a study needs before it launches. The agents produce CDASH-compliant eCRFs and edit checks, informed consent in 30+ languages, SDTM annotations, and smart data-capture components. This is the foundation the rest of the trial runs on.
Clean data and continuous oversight, in real time.
Capture source data, catch the gaps, and close out queries without the manual chase. Risk-based monitoring, adverse-event detection, and safety-signal management run alongside, keeping the study clean and inspection-ready while it's live.
Submission-ready datasets, outputs, and reports.
Generate CDISC SDTM and ADaM datasets, Define.xml, and Tables, Listings & Figures that pass Pinnacle 21 clean, then draft ICH E3 clinical study reports and patient narratives, with predictive analytics on top.
A compliant eTMF and an AI project team.
Keep an inspection-ready electronic Trial Master File that auto-files and classifies itself to the TMF Reference Model, run project management and physician communication end-to-end, and give every user a fast, AI-triaged support desk.
At a glance
What we stand for
Clinical research is unforgiving of shortcuts. These are the commitments we hold ourselves to.
In clinical research, an unvalidated shortcut is worthless. We design for the inspector first, so audit trails, traceability, and validation are foundational rather than features we add later.
AI should give clinical professionals their time back without taking their judgment away. Every agent has a human owner who stays accountable for what ships.
We label pre-launch targets as targets. We would rather earn trust slowly with real evidence than overstate results we cannot yet stand behind.
Point tools create handoff gaps where errors hide. We build one connected platform from protocol to archive so data and documents flow without re-keying.
Built for regulated trials
Every agent runs inside a validated, audit-ready platform aligned to the standards clinical teams and inspectors expect.
Electronic records and signatures with full audit trails, access controls, and validation.
Good Clinical Practice, including risk-based quality management and computerized-system expectations.
Standards-based data capture, tabulation, and analysis datasets that validate clean in Pinnacle 21.
PHI safeguards, de-identification, and role-based access across the platform, with a signed BAA for every healthcare entity we work with.
Breach-notification and enforced-security obligations that extend HIPAA to us as your business associate.
Lawful processing, data-subject rights, and EU data-residency support for global trials.
Security, availability, and confidentiality controls audited against Trust Services Criteria.
Certified information-security management system governing the whole platform.
AI management system for responsible, governed, and auditable use of AI.
We are building to ISO 42001, the international management-system standard for AI, so that governance, traceability, and accountability are engineered into how our agents are developed, validated, and monitored, not left to policy documents.
Book a walkthrough of the agentic platform, or talk to a clinical-trials expert about where it fits in your workflow.
