CTIS

Health IT Servicesctisinc.com

CTIS is a Rockville, Maryland-based Women-Owned Small Business providing health IT services to federal healthcare agencies and academic medical centers, and in April 2026 launched Trial SafetyXchange, a SaaS platform that automates FDA E2B(R3) adverse event reporting compliance for pharma, biotech, and CRO customers.

Company typePrivate
Founded1993
HeadquartersRockville, United States
Headcount101–250
GTM typeB2B
OfferingServices

What CTIS does

CTIS, Inc. is a privately held, Women-Owned Small Business headquartered in Rockville, Maryland, with over 30 years of experience in health IT and clinical research informatics. The company provides end-to-end Health IT services including Data Services, Health Information Solutions, IT Modernization, AI/ML Enablement, IT Infrastructure and Security, and DevSecOps, primarily to federal healthcare and research agencies (NIH, FDA, VA, CMS, FDIC) and academic medical institutions (Georgetown University, Johns Hopkins, Moffitt Cancer Center). CTIS holds ISO 9001, ISO 27001, ISO 20000-1, and CMMI Level 3 certifications, AWS Partner status, and access to multiple federal contract vehicles (GSA MAS, CIO-SP3 SB, NCI CBBIIT PITS BPA, SPARC-SB, FDIC ITAS NG BOA) that anchor its government services revenue.

In April 2026, CTIS launched Trial SafetyXchange, a cloud-based SaaS platform that automates the conversion of Individual Case Safety Report files from the legacy E2B(R2) format to the FDA-mandated E2B(R3) standard for adverse event reporting. The product is targeted at small and mid-size pharmaceutical companies, biotech firms, and contract research organizations facing the FDA's April 1, 2026 compliance deadline and positioned as a low-cost, immediately deployable alternative to enterprise pharmacovigilance platforms. CTIS combines subscription SaaS revenue from Trial SafetyXchange with managed and professional services revenue from its federal health IT practice, distributed through a sales-led enterprise motion with quote-based engagement and no public pricing.

CTIS firmographics

Firmographics

Name: CTIS
Legal name: CTIS, Inc.
Website: https://ctisinc.com
Company type: Private
Founded year: 1993
Operating status: Operating
Headcount range: 101–250 employees
Short description: CTIS is a Rockville, Maryland-based Women-Owned Small Business providing health IT services to federal healthcare agencies and academic medical centers, and in April 2026 launched Trial SafetyXchange, a SaaS platform that automates FDA E2B(R3) adverse event reporting compliance for pharma, biotech, and CRO customers.
Ownership category
akta.pro rank

CTIS industry classification

Industry

Product category: Health IT Services
NAICS: Computer Systems Design and Related Services (54151)
SIC: Services-Prepackaged Software (7372)
akta.pro primary industry: Safety/Pharmacovigilance (PV) & Clinical Safety Systems (HLACAOAH)
akta.pro secondary industries: Clinical Trial Management Systems (CTMS) (HLACAOAD), Safety Database Operations & Hosting (Argus/ARISg/Oracle) (HLAGALAB)

Keywords

Health IT services
Clinical trial compliance
FDA regulatory solutions
Health informatics
IT modernization

Where CTIS is headquartered

Location

Headquarters

HQ city: Rockville
HQ country: United States
HQ region: North America

Offices1 record

Markets served

CTIS business model

Business model

GTM type: B2B
Offering type: Services
Cost components: Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

SaaS Subscription (Trial SafetyXchange): Cloud-based SaaS subscription model for the Trial SafetyXchange platform. Offers immediate deployment as an affordable alternative to traditional enterprise compliance platforms for FDA E2B(R3) compliance.
Health IT Services: End-to-end solutions including Data Services, Health Information Solutions, IT Modernization, AI/ML Enablement, IT Infrastructure & Security, and DevSecOps delivered as professional services and managed services.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels3 records

CTIS product offering

Product offering

Core offering

CTIS is a Health IT and clinical research informatics company that delivers end-to-end solutions spanning Data Services, Health Information Solutions, IT Modernization, AI/ML Enablement, IT Infrastructure & Security, and DevSecOps. Its flagship product, Trial SafetyXchange, is a cloud-based SaaS platform that automates the conversion of Individual Case Safety Report (ICSR) files from the legacy E2B(R2) format to the FDA-mandated E2B(R3) standard for adverse event reporting compliance ahead of the April 1, 2026 deadline.

Product overview

CTIS offers a portfolio of Health IT and clinical research informatics solutions. The primary product is Trial SafetyXchange, a cloud-based SaaS platform designed for FDA compliance in clinical trials. The company also provides end-to-end solutions including Data Services, Health Information Solutions, IT Modernization, and AI/ML Enablement capabilities.

Differentiator

Problem solved

Functional benefit

Brands

Trial SafetyXchange: Cloud-based SaaS solution that automates the conversion of Individual Case Safety Report files from the legacy E2B(R2) format to the FDA-mandated E2B(R3) standard for adverse event reporting compliance.

Products and services

Trial SafetyXchange A cloud-based SaaS solution that automates the conversion of Individual Case Safety Report (ICSR) files from the legacy E2B(R2) format to the FDA-mandated E2B(R3) standard, helping pharmaceutical companies, biotech firms, and CROs meet the April 1, 2026 compliance deadline for adverse event reporting in clinical trials.
Health IT End-to-End Solutions

Quantifiable outcome

Addresses FDA April 1, 2026 compliance deadline for adverse event reporting

Companies that use CTIS

Customer profile

Named customers6 records

Segments4 records

Ideal customer profiles4 records

CTIS technology and API

Technology

Technology focussed Yes

API detail

Has API: No
API docs
API detail

Core technology

AI maturity

App detail

Feature1 record

CTIS partnerships and signals

Strategic signal

Partnerships

Two partnerships are on record, tiered core and flagship.

AWS (Amazon Web Services)coreTechnology or IntegrationCTIS holds AWS Partner status, indicating cloud infrastructure and technology integration partnership for delivering SaaS solutions.
U.S. Federal GovernmentflagshipStrategic or Co-development PartnerCTIS holds multiple government contract vehicles including GSA Multiple Award Schedule, CIO-SP3 SB, NCI CBBIIT PITS BPA, SPARC-SB, and FDIC ITAS NG BOA, enabling direct procurement by federal agencies including NIH, FDA, VA, and CMS.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

CTIS competitors and assessment

Company assessment

Broad incumbents

Leidos: Leidos is a large federal health IT contractor serving NIH, FDA, VA, and CMS — directly overlapping CTIS's federal healthcare agency customer base and contract vehicle footprint.
IQVIA: IQVIA is a global CRO and health IT provider with safety/pharmacovigilance services and technology; it operates across the full clinical trial lifecycle that CTIS targets via its narrower SMB-focused SaaS offering.
Booz Allen Hamilton: Booz Allen is a major federal health IT and digital modernization contractor, comparable to CTIS's federal health IT services arm across NIH, FDA, VA, and CMS engagements.

Direct peers

Sparta Systems (TrackWise): TrackWise provides quality and safety management for pharma, including adverse event and case management workflows overlapping with CTIS's Trial SafetyXchange use case.
Veeva Systems: Veeva's Vault Safety is a leading cloud-based pharmacovigilance platform for adverse event reporting and ICSR management, directly competing with CTIS's Trial SafetyXchange for the same pharma/biotech/CRO buyer.
ArisGlobal: ArisGlobal's LifeSphere Safety platform provides pharmacovigilance, case management, and E2B submission software, competing head-on with Trial SafetyXchange for pharma safety teams.
Dassault Systèmes (Medidata): Medidata's clinical trial technology suite includes safety reporting and E2B submission capabilities serving pharma and CROs, an adjacent but comparable offering to CTIS's Trial SafetyXchange.
Oracle Health Sciences (Argus Safety): Oracle's Argus Safety is the dominant enterprise safety database for ICSR/E2B submissions and adverse event reporting, the primary incumbent CTIS positions Trial SafetyXchange against for SMB and mid-market pharma.

Others

Parexel International: Parexel is a global CRO that relies on pharmacovigilance and safety reporting technology for its sponsor clients, making it a potential channel partner and indirect buyer profile for Trial SafetyXchange.

Emerging players

Saama Technologies: Saama provides AI-enabled clinical trial and pharmacovigilance analytics, competing with CTIS in clinical research informatics SaaS for pharma and biotech with overlapping buyer personas.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key highlights7 records

Customer concentration

CTIS compliance and trust

Trust signal

Compliance4 records

CTIS financial estimates

Financial estimate

Revenue estimate

Valuation estimate

CTIS leadership team

Management profile

Number of profiles

CTIS funding detail

Funding detail

Funding overview

Funding rounds

Investors

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

CTIS M&A and investment

M&A and investment

M&A

Investments

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

Frequently asked questions about CTIS

What does CTIS do?

Is CTIS a public or private company?

CTIS is a private company. It is classified as founder individual operated bootstrapped and is currently operating.

When was CTIS founded?

CTIS was founded in 1993. It employs 101 to 250 people.

Where is CTIS based?

CTIS is headquartered in Rockville, United States, in the North America region.

How does CTIS make money?

Two revenue lines are on record. SaaS Subscription (Trial SafetyXchange) is the primary driver. The others are health IT Services.

Who are CTIS's main competitors?

Broad incumbents on record are Leidos, IQVIA and Booz Allen Hamilton. Direct peers are Sparta Systems (TrackWise), Veeva Systems, ArisGlobal, Dassault Systèmes (Medidata) and Oracle Health Sciences (Argus Safety). Parexel International is listed as an others. Saama Technologies is listed as an emerging player.

Does CTIS have an API?

No public API is recorded for CTIS.

What industry is CTIS in?

CTIS's product category is Health IT Services. Its primary akta.pro industry code is HLACAOAH, Safety/Pharmacovigilance (PV) & Clinical Safety Systems, with a secondary code of HLACAOAD, Clinical Trial Management Systems (CTMS). Its NAICS code is 54151 and its SIC code is 7372.