Clinical Informatics Research Unit

What Clinical Informatics Research Unit does

Clinical Informatics Research Unit (CIRU) is an applied research and enterprise unit embedded within the Faculty of Medicine at the University of Southampton, founded circa 1998 and operating for over 25 years in clinical research informatics. CIRU builds and operates a four-product platform — EDGE (web-based clinical trials and research portfolio management), CORE (eCRF/EDC design, database build, validation, and data management services), AXIS (clinical data extraction, integration, and genomic data hosting within the NIHR Southampton Biomedical Research Centre), and KITE (bespoke healthcare innovation applications such as STAG diabetes decision support, UHS Revalid, and FollowApp) — covering the full lifecycle from study setup through to data analysis. The technology stack is a SaaS-delivered, browser-based research informatics platform with cross-device support in EDGE 3 (launched November 2023), ISO 27001 and Cyber Essentials security posture, and integration into NHS and international trial networks. CIRU monetises primarily via annual subscription licences for EDGE to NHS trusts and international clinical research organisations, plus professional services revenue from CORE (eCRF/EDC delivery for trial sponsors and CROs) and AXIS (data science services). Its customer base is concentrated in NHS hospitals (~80% of UK trusts), Canadian paediatric oncology networks (C17 across 34 centres), Australasian research hospitals, and emerging deployments in South Africa, India, and Brazil; go-to-market is enterprise field sales supported by an annual user conference (~400 delegates) and a strong peer-referral community. CIRU is privately held within the University of Southampton with no external venture funding, is led by Director Professor James Batchelor alongside named Heads of Data Security, Operations & Delivery, Software Development, and Trading Services, and runs on roughly 39 staff (2022 baseline).

Name

Clinical Informatics Research Unit

Legal name

Clinical Informatics Research Unit

Website

https://the-ciru.com

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

11–50 employees

Short description

CIRU, an applied research unit within the University of Southampton, builds and operates the EDGE clinical trials management platform plus CORE, AXIS, and KITE data services for NHS trusts (covering ~80%) and international clinical research organisations across 36 countries.

Ownership category

akta.pro rank

Product category

Clinical Trials Management Software

NAICS

Other Scientific and Technical Consulting Services (54169), Custom Computer Programming Services (541511)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro industry

PRIMARYHLACAOAA

Electronic Data Capture (EDC) Platforms

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

SECONDARYHLAGAOAA

Clinical Operations & Monitoring FSP (CRA/CTM/Start-up)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Scientific Staffing & Functional Service Providers (FSP)

SECONDARYHLACAOAO

Biostatistics, Statistical Computing & Clinical Programming (SAS/R/Pipelines)

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

Keywords

• Clinical trials management software
• Clinical research informatics
• Electronic data capture
• Healthcare data integration
• Research portfolio management

Headquarters

HQ city

Southampton

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. EDGE Subscription: EDGE software is offered as a subscription service to NHS trusts, universities, and international clinical research organizations. The system supports research management and clinical trials coordination globally.
2. CORE Data Services: Clinical data management services including eCRF design, database build, validation, data management, and quality control for clinical trials. Handles studies from NATASHA trial to smaller investigator-led studies.
3. AXIS Data Science Services: Data extraction, analysis, validation, and integration services. Includes genomic data hosting and feasibility investigation support for cohort estimation.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

CIRU develops, licenses and supports the EDGE clinical trials management system used by NHS trusts and international clinical research organisations to manage research portfolios, track studies and coordinate multi-site trials. Alongside EDGE, CIRU delivers professional clinical data management services through CORE (eCRF/EDC design, validation and trial data management), data extraction and integration work through AXIS, and bespoke healthcare application development through KITE (including tools such as STAG for diabetes management and UHS Revalid for clinical staff appraisal).

Product overview

CIRU offers a suite of clinical informatics products and services. The core portfolio includes EDGE (clinical trials management software), CORE (electronic data capture/eCRF services), AXIS (clinical data extraction and data science), and KITE (bespoke healthcare innovation applications). These products work together to provide end-to-end clinical research solutions—from study management and data capture through to data analysis and healthcare innovation—supporting over 100,000 research projects across 36 countries globally.

Differentiator

Problem solved

Functional benefit

Brands

• EDGE: Clinical Trials Management Programme - research management software used by NHS and international research organisations
• CORE
• AXIS
• KITE

Products and services

• EDGE Clinical Trials Management Programme - a web-based research management system used by NHS trusts and international clinical research organisations for managing research portfolios, tracking studies, coordinating clinical trials, supporting remote monitoring, electronic delegation logs, e-TMF, e-ISF and study setup across 36 countries.
• CORE (Clinical On-demand Research) Electronic Case Report Form (eCRF) and Electronic Data Capture (EDC) service providing database design, validation, data management and quality control for clinical trials, supporting studies ranging from large multi-site trials (e.g. NATASHA) to smaller investigator-led studies.
• AXIS (Access Extract Integrate Safe Data) Data science and clinical data extraction, transformation and integration framework operating within the NIHR Southampton Biomedical Research Centre, providing advanced data analysis, cohort estimation and genomic data hosting services for research studies.
• KITE (Knowhow Ideas That Excite) Bespoke healthcare innovation application development service producing custom applications including the STAG diabetes management tool, UHS Revalid clinical staff appraisal system, FollowApp patient interaction app and Electronic Medical Record solutions for NHS trusts and healthcare organisations.

Quantifiable outcome

• 80% of NHS trusts utilize EDGE for clinical research management
• +3 more outcomes

Named customers10 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• Global Alliance on War, Conflict & Health (GAWCH)coreStrategic or Co-development Partner · 1 January 2022Global community aiming to strengthen action on war and conflict. Director Professor James Batchelor serves as Co-Chair and only UK University representative on the Executive Board.
• Commonwealth Centre for Digital HealthcoreStrategic or Co-development Partner · 1 January 2020CIRU Director Professor James Batchelor serves as Co-director with Prof Jo Nurse. The centre supports cross-commonwealth collaboration and coordination of digital/eHealth work, initially providing placements for 12 Commonwealth Digital Health Fellows from Sri Lanka.
• NIHR Southampton Biomedical Research CentrecoreStrategic or Co-development Partner · 1 January 2019AXIS is part of the NIHR Southampton Biomedical Research Centre 5-year funding programme, working within the Data Science cross-cutting theme. The partnership focuses on clinical data extraction, transformation, and integration with research data.
• University Hospital Southampton NHS Foundation TrustcoreStrategic or Co-development PartnerPrimary NHS trust partner for clinical research and healthcare innovation. Multiple joint projects including STAG diabetes tool, COVID-19 response, and clinical data integration initiatives.
• C17 Network (Canada)coreStrategic or Co-development PartnerCollaborative network of paediatric haematology, oncology, and stem cell transplant programs implementing EDGE across Canadian centres. Includes Hospital for Sick Kids Toronto, Montreal Children's Hospital, Stollery Children's Hospital, and Alberta Children's Hospital (34 total centres).
• Starship Children's Hospital, AucklandcoreStrategic or Co-development PartnerLeading New Zealand children's hospital implementing EDGE for blood and cancer research management, alongside colleagues at ADHB and University of Auckland.
• University of Cape Town (South Africa)coreStrategic or Co-development PartnerUCT Clinical Research division working with CIRU on EDGE implementation for clinical research management in South Africa.
• K.J. Somaiya Hospital and Research Centre, MumbaiminorStrategic or Co-development PartnerCTRU in Mumbai, India started EDGE training and implementation for clinical trials research management.
• International Blast Injury Research Network (IBRN)coreStrategic or Co-development PartnerNetwork bringing together engineers and clinicians to address real-world blast injury problems with humanitarian focus. Co-founded by CIRU researchers Dr Jack Denny and Dr Becky Brown.
• 3CTN (Canadian Cancer Clinical Trials Network)coreStrategic or Co-development PartnerCanadian network collaborating with C17 network on clinical trial management using EDGE platform.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• OpenClinica: OpenClinica offers open-source and enterprise EDC/CTMS solutions for clinical research. It competes with CIRU's CORE/EDGE products among academic medical centers and clinical trial units.
• Veeva Systems: Veeva Vault CTMS and Vault EDC are widely deployed cloud platforms for clinical trials management and electronic data capture. Like CIRU, Veeva sells subscription software to research sponsors, CROs, and academic sites globally, but at vastly larger scale.
• DF/Net Research: DF/Net Research provides EDC, clinical data management, and biostatistics services to academic and small-sponsor trials. Like CIRU's CORE offering, it specializes in supporting investigator-initiated and academic clinical research.
• Oracle Clinical One: Oracle Clinical One is a unified EDC, CTMS, and RTSM platform used by global pharma and CROs. It directly overlaps with CIRU's EDGE (CTMS) and CORE (EDC) products for clinical trials management.
• Medidata Solutions (Dassault Systèmes): Medidata Rave EDC and Rave CTMS are the market-leading unified clinical trial technology platforms. CIRU's EDGE/CORE offerings compete in the same EDC/CTMS category for clinical research sites and sponsors.

Emerging players

• Castor EDC: Castor provides a cloud-based EDC and ePRO platform targeted at academic researchers, hospitals, and CROs. Like CIRU, it focuses on serving research sites and investigator-initiated studies with a SaaS model.
• Florence Healthcare: Florence provides eRegulatory (eISF/eTMF) and CTMS solutions for clinical research sites and sponsors. It addresses adjacent parts of the clinical trial technology stack that CIRU's EDGE platform covers.
• Reify Health (StudyTeam): Reify Health's StudyTeam and Care Access platforms support clinical trial site activation, enrollment, and patient engagement. The site-management focus directly overlaps with parts of EDGE's research portfolio tracking.

Broad incumbents

• IQVIA (CTMS / Digital Health): IQVIA offers broad clinical development technology and CRO services including CTMS and EDC. Its scale and global reach make it a benchmark incumbent against which CIRU competes for NHS and international research institution contracts.
• IBM Clinical Development: IBM's eCRF/EDC and clinical trial management capabilities target large pharma sponsors. It overlaps with CIRU's EDC and CTMS offerings but operates at significantly greater enterprise scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/CIRUsoton

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Clinical Informatics Research Unit