About NeogeniQS

Your trial's real bottleneck isn't the science. It's everything around it.

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.

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Our mission

Make clinical trials faster to run and easier to trust.

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 participants 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.

What we build

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.

  • CDASH-compliant eCRFs, edit checks & SDTM annotations
  • Informed consent in 30+ languages
  • SDTM/ADaM datasets, Define.xml & Pinnacle 21-clean TLFs
  • ICH E3 clinical study reports & participant narratives
  • A TMF Reference Model-aligned electronic Trial Master File

Our founders

Meet the people behind NeogeniQS.

The founding team building our vision for clinical research.

Portrait of Vaibhav Singh

Vaibhav Singh

Co-founder

Vaibhav is Co-Founder and technology leader at NeogeniQS, driving the development of an agentic AI platform that streamlines clinical trial execution by automating complex, repetitive workflows while keeping clinical experts in control. A technology leader with more than 17 years of experience, Vaibhav has built his career at the intersection of artificial intelligence, machine learning, and large-scale technology transformation. At ADP, he leads AI-driven modernization initiatives, applying large language models and agentic AI to automate complex processes, accelerate engineering, and turn enterprise data into a foundation for intelligent systems. That work has shaped his belief that AI delivers lasting value only when it's paired with strong governance, security, and reliability, a principle that matters even more in regulated industries like clinical research. At NeogeniQS, he brings that perspective to helping pharma, biotech, and CRO teams adopt AI and intelligent automation with confidence, working alongside the systems they already use rather than replacing them.

Portrait of Dhaval Desai

Dhaval Desai

Co-founder

Dhaval Desai is Co-Founder and Chief Technology Officer at NeogeniQS, where he leads technology strategy, platform architecture, and AI engineering. With over 18 years of experience in healthcare technology and enterprise systems, he specializes in clinical research platforms, intelligent automation, healthcare interoperability, and regulatory compliance. At NeogeniQS, Dhaval leads the development of an agentic AI platform designed to streamline clinical trial operations, from protocol development through regulatory submission. His approach emphasizes responsible AI implementation, combining intelligent workflow automation with human oversight, traceable outputs, and rigorous validation to support accuracy, transparency, and regulatory readiness. His expertise includes designing and implementing secure, scalable healthcare systems aligned with standards and frameworks such as FDA 21 CFR Part 11, ICH E6, HIPAA, and SOC 2. He is committed to advancing clinical research through reliable, compliant, and scalable AI solutions that improve operational efficiency while keeping clinical experts at the center of critical decisions.

Portrait of Abhinav Sharma

Abhinav Sharma

Co-founder

Abhinav Sharma is Co-Founder of neogeniqs, working across strategy, operations, program management, technology, marketing, and customer engagement. With a background in enterprise data, database architecture, cloud platforms, and large-scale technology delivery, he brings a strong execution and delivery perspective to the company. He focuses on connecting company priorities with cross-functional execution, helping team move initiatives from planning through delivery while supporting product development, go-to-market activities, operational readiness, and other key business functions as neogeniqs grows its clinical research platform and expands its market presence.

Portrait of Dr. Meegha Agrawaal

Meegha Agrawaal, Ph.D.

Co-founder & Chief Scientific Officer

Dr. Meegha Agrawaal is Co-founder and Chief Scientific Officer of NeogeniQS and a senior scientific executive with over 15 years of experience leading clinical research operations, translational science, and biotechnology innovation. With a career spanning academic leadership and corporate clinical development, Dr. Agrawaal brings a rare perspective to the intersection of GxP-regulated environments, laboratory infrastructure, and advanced technology integration. Her scientific foundation, rooted in a Ph.D. in Biotechnology with a focus on Neuroscience from the Indian Institute of Technology (IIT), informs her approach to clinical rigor. She subsequently held research and academic leadership roles at the University of Florida, Children’s National Medical Center, Washington DC, and the University of Illinois Chicago. Her scientific work has encompassed neuroscience, neuroprotection, cerebral stroke, healthy-ageing, diagnostics, biomarkers, and translational research. As Director of Scientific & Clinical Operations at Betterhumans, Dr. Agrawaal has directed complex scientific and clinical operations, including the oversight of multi-site clinical sample collections, the establishment of cGMP manufacturing facilities, and the design of state-of-the-art tissue culture laboratories. Her operational leadership has been instrumental in securing significant private investment and corporate grants, where she managed portfolios of simultaneous high-stakes projects while maintaining strict adherence to SOP, CAPA, and regulatory inspection readiness. A prolific scientific communicator, Dr. Agrawaal has authored over 100 publications and three books and has served as the Chief Editor of a scientific magazine. At NeogeniQS, she leverages this deep domain expertise to guide the development of agentic AI solutions. Her mission is to ensure that AI serves as a precision tool that augments clinical experts, reducing the operational burden of eTMF and trial management while reinforcing the scientific integrity and human accountability required in regulated research.

Portrait of Adaline S. Kumar

Adaline S. Kumar

Co-founder

Adaline S. Kumar is a clinical operations, procurement, and vendor management leader with over 20 years of experience across the pharmaceutical and clinical research industries. Her career spans strategic sourcing, clinical outsourcing, contract lifecycle management, and vendor governance, with a strong record of connecting scientific innovation, clinical execution, and commercial strategy. Adaline has supported clinical research and outsourcing initiatives for leading global pharmaceutical and biotechnology organizations, including Merck, Takeda, Otsuka, Ipsen, ICON, and BeiGene. She has managed complex CRO and vendor relationships, negotiated high-value agreements, and optimized clinical budgets, partnering closely with Clinical Operations, Legal, Finance, Procurement, and R&D functions. Her expertise covers the full clinical development lifecycle, from Phase I through Phase IV, in environments governed by ICH-GCP and GLP. A background in Neurobiology and Research Methodology/Statistics, together with published research and professional training in drug development and health policy, gives her a distinctive ability to bridge scientific, operational, and business priorities. She is also experienced with enterprise procurement and clinical technology platforms, including COUPA, SAP, Ariba, CTMS, and EDC systems. At NeogeniQS, Adaline focuses on the intersection of clinical operations, compliance, and AI-enabled clinical research. Known for her collaborative leadership, she applies emerging technology to improve trial efficiency, data integrity, operational oversight, and inspection readiness, helping sponsors build stronger vendor ecosystems, streamline contracting, and accelerate clinical development.

The agentic approach

Why this is safe to put anywhere near your regulated trial.

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.

Agents that do the work, not a chatbot that answers

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.

Grounded in your documents

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.

Human-in-the-loop by design

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.

Validated and inspection-ready

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.

Pilot Availability: NeogeniQS is live and onboarding a limited number of pilot customers. Features and capabilities described here reflect the current platform and roadmap and may evolve as we ship. Contact us about pilot participation and early-partner pricing.

The platform

One platform across the whole trial lifecycle.

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.

Study Build & Design

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.

Data Management & Oversight

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.

Biostatistics & Reporting

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 participant narratives, with predictive analytics on top.

A compliant eTMF and an AI project team.

Documents, Operations & Support

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.

Explore the platformBrowse all 37 agents

At a glance

The platform, by the numbers.

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specialized AI agents across the trial lifecycle
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agent families spanning 4 value-chain suites
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less study-specification time· target
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languages for informed consent and site materials

What we stand for

Principles that shape every agent we ship.

Clinical research is unforgiving of shortcuts. These are the commitments we hold ourselves to.

Compliance is the product

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.

Augment the expert

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.

Honest about proof

We label modeled targets as targets. We would rather earn trust with real evidence than overstate results we cannot yet stand behind.

Built for the whole lifecycle

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

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

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.

Frequently asked questions

See the platform on your study

Book a walkthrough of the agentic platform, or talk to a clinical-trials expert about where it fits in your workflow.

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