Agilis
Agilis is a privately held Athens-based clinical trial technology and services company providing proprietary cloud EDC/CTMS software alongside clinical data management, biostatistics, and CDISC programming services to pharmaceutical, biotech, and CRO clients globally.
- Company typePrivate
- Founded1998
- HeadquartersAthens, Greece
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Agilis does
Agilis S.A. Statistics & Informatics is a privately held Société Anonyme headquartered in Athens, Greece, founded in 1998 with registered capital of €578,048. The company develops and operates a proprietary cloud-based clinical trial technology stack and provides integrated clinical data management, biostatistics, and CDISC programming services. Its primary customers are major multinational pharmaceutical companies, innovative biotech firms, and specialized contract research organizations, with secondary engagement from academic institutions and government/international organizations conducting multi-country patient registries and post-marketing studies.
The core platform is a 21 CFR Part 11 compliant cloud EDC/CTMS built on Oracle Database with Java, JavaScript, and React, using a metadata-driven architecture that enables dynamic eCRF generation, validation rules, and information flows. Adjacent proprietary modules include an Interactive Web Response System (IWRS) for randomization, a Patient Reported Outcome/Clinical Outcome Assessment (PRO/COA) module supporting multi-country multilingual deployments, a medical image assessment and adjudication tool, and — launched in July 2024 — a cloud lab sample tracking tool with barcode-based requisition, discrepancy detection, and API integration to third-party EDC systems. A proprietary SDTM Generator, also launched in July 2024, automates transformation of clinical database data into CDISC SDTM and ADaM datasets using metadata, reducing traditional SAS/R programming effort and human error risk. The complete offering is governed by an integrated ISO 9001 and ISO 27001 certified Quality and Information Security Management System, with documented GCP, EU-GDPR, CDASH, SDTM, ADaM, and ICH E3 compliance.
Agilis generates revenue through quote-based enterprise contracts combining SaaS subscription fees for its cloud platform with project-priced professional services across data management, biostatistics, and CDISC programming. Customer engagement is direct and field-led, with the company's engineers and statisticians embedded into sponsor trial teams rather than positioned as licensed software vendors. The company reports 62+ clinical studies, 40+ sponsors and CROs, 43,815 enrolled study participants, and 3,826 EDC users across 12 countries on four continents. Agilis is led by Gregory Farmakis as President and Managing Director, holds Greek CRO registration (155-C-23), and obtained French Private Research Organisation status in February 2024 to support French customer tax-credit eligibility.
Agilis firmographics
Firmographics- Name
- Agilis
- Legal name
- Agilis S.A. Statistics & Informatics
- Website
- https://agilis.gr
- Company type
- Private
- Founded year
- 1998
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Agilis is a privately held Athens-based clinical trial technology and services company providing proprietary cloud EDC/CTMS software alongside clinical data management, biostatistics, and CDISC programming services to pharmaceutical, biotech, and CRO clients globally.
- Ownership category
- akta.pro rank
Agilis industry classification
Industry- Product category
- Clinical Trial Management Software
- NAICS
- Custom Computer Programming Services (541511), Scientific Research and Development Services (5417), Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services (51821)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)
- akta.pro secondary industries
- Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Biostatistics, Statistical Computing & Clinical Programming (SAS/R/Pipelines) (HLACAOAO), Clinical Trial Management Systems (CTMS) (HLACAOAD), Electronic Data Capture (EDC) Platforms (HLACAOAA)
Keywords
Where Agilis is headquartered
LocationHeadquarters
- HQ city
- Athens
- HQ country
- Greece
- HQ region
- Europe
Offices1 record
Markets served
Agilis business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D
Revenue model
- Cloud Software as a Service (SaaS): Agilis offers their EDC/CTMS, lab sample tracking, and other clinical trial software as cloud-based SaaS services. This provides recurring revenue from software licensing and hosting fees.
- Clinical Data Management Services: Professional services including data management planning, database setup, continuous data monitoring, data cleaning, audit, database lock, export and TMF archiving. Team of experienced data managers provide end-to-end data management.
- Biostatistics and Statistical Programming: Statistical analysis services including study design, sample size estimation, SAP preparation, statistical programming in SAS or R, TLF generation, CDISC/ADAM datasets, and clinical study reports following ICH E3 guidelines.
- CDISC Programming Services: CDISC compliance services including CDASH and SDTM annotated CRFs, SDTM, ADaM and analysis scripts. Uses proprietary CDISC Generator software for automated transformations.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Multi-year contract | Enterprise Custom Pricing |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels4 records
Agilis product offering
Product offeringCore offering
Agilis develops and operates a proprietary cloud-based EDC/CTMS platform offered as SaaS to pharmaceutical, biotech, and CRO clients for collecting and managing clinical trial data, including integrated modules for lab sample tracking, IWRS randomization, PRO/COA capture, and medical image assessment. Alongside the software, the company sells clinical data management, biostatistics, and CDISC programming professional services that together cover the clinical trial data lifecycle from protocol design through regulatory submission.
Product overview
Agilis offers a unified cloud-based clinical trial technology platform centered around its Cloud EDC/CTMS system, complemented by specialized add-on modules including IWRS (Interactive Web Randomization), PRO/COA (Patient Reported Outcomes/Clinical Outcome Assessment), Medical Image Assessment Adjudication, and a CDISC SDTM Generator. The company provides a comprehensive portfolio of complementary services including Biostatistics, Clinical Data Management, and CDISC Programming services. The Lab Sample Tracking Tool functions as an integral part of the eCRF/CTMS system. The entire portfolio is built around their proprietary software systems, enabling end-to-end clinical trial data management from collection through regulatory submission.
Differentiator
Problem solved
Functional benefit
Products and services
- Cloud EDC/CTMS (eCRF)
Quantifiable outcome
- SDTM datasets created in less time and at lower cost than typical programming approaches
- +2 more outcomes
Companies that use Agilis
Customer profileNamed customers5 records
Segments5 records
Ideal customer profiles4 records
Agilis technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
Feature6 records
Agilis partnerships and signals
Strategic signalScale indicators9 records
Recent moves6 records
Expansion highlights5 records
Agilis competitors and assessment
Company assessmentBroad incumbents
- Medidata (Dassault Systèmes): Industry-leading EDC/CTMS and clinical trial platform (Rave EDC) used by most major pharmaceutical sponsors. Comparable to Agilis as a cloud-based EDC/CTMS provider, but operates at much greater scale with a broader portfolio covering randomization, eCOA, imaging, and trial management.
- Veeva Systems: Enterprise cloud software provider for life sciences with the Vault CTMS and Vault EDC suite. Comparable to Agilis as a SaaS clinical trial technology vendor, but serves a much broader life sciences R&D and commercial portfolio.
- Oracle Clinical One: Oracle's unified clinical trial platform (EDC, RTSM, CTMS) targeted at large pharma. Comparable to Agilis on EDC/CTMS functionality, but backed by Oracle's infrastructure and global enterprise reach.
Direct peers
- Cytel: Specialized biostatistics and CDISC programming services provider with proprietary tools (e.g., Solara). Comparable to Agilis on biostatistics, CDISC programming, and clinical data management services for pharma/biotech/CRO customers.
- Clario: Scientifically-focused clinical trial technology company delivering EDC, eCOA, medical imaging, and respiratory endpoints. Comparable to Agilis on EDC and clinical outcome assessment functionality, with deeper imaging specialization.
- Signant Health: Clinical trial technology provider offering eCOA, EDC, IRT, and patient-centric solutions (formed from merger of CRF Health and Bracket). Directly comparable to Agilis as a focused eClinical technology vendor serving pharma and CRO customers with both software and supporting services.
- ArisGlobal: Life sciences technology platform offering EDC, CTMS, safety, and regulatory information management. Comparable to Agilis as a clinical trial software vendor serving mid-to-large pharma, with broader safety/pharmacovigilance capabilities.
Emerging players
- Castor: Cloud-based EDC platform targeting academic and commercial clinical trials with a self-service model. Comparable to Agilis on cloud EDC functionality, but focuses more on decentralized and academic studies with plug-and-play deployment.
- OpenClinica: Open-source and enterprise EDC/CTMS platform for clinical trials. Comparable to Agilis on cloud-based EDC/CTMS for clinical research, typically serving academic and small-to-mid biotech customers.
- Formedix: Clinical trial metadata repository and CDISC automation platform. Comparable to Agilis on the CDISC automation and metadata-driven approach, with deeper focus on standards-based study design tooling.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Agilis social profiles
Digital presenceAgilis compliance and trust
Trust signalCompliance8 records
Agilis financial estimates
Financial estimateRevenue estimate
Valuation estimate
Agilis leadership team
Management profileNumber of profiles
Profiles4 records
Agilis funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Agilis M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Agilis
What does Agilis do?
Agilis develops and operates a proprietary cloud-based EDC/CTMS platform offered as SaaS to pharmaceutical, biotech, and CRO clients for collecting and managing clinical trial data, including integrated modules for lab sample tracking, IWRS randomization, PRO/COA capture, and medical image assessment. Alongside the software, the company sells clinical data management, biostatistics, and CDISC programming professional services that together cover the clinical trial data lifecycle from protocol design through regulatory submission.
Is Agilis a public or private company?
Agilis is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Agilis founded?
Agilis was founded in 1998. It employs 11 to 50 people.
Where is Agilis based?
Agilis is headquartered in Athens, Greece, in the Europe region.
How does Agilis make money?
Four revenue lines are on record. Cloud Software as a Service (SaaS) is the primary driver. The others are clinical Data Management Services, biostatistics and Statistical Programming and CDISC Programming Services.
Who are Agilis's main competitors?
Broad incumbents on record are Medidata (Dassault Systèmes), Veeva Systems and Oracle Clinical One. Direct peers are Cytel, Clario, Signant Health and ArisGlobal. Emerging players are Castor, OpenClinica and Formedix.
Does Agilis have an API?
Yes. The Sample Tracking Tool is designed to be easily integrated with any third-party EDC software possessing an API for subject data retrieval. The lab sample tracking software supports data exchange via API integration.
What industry is Agilis in?
Agilis's product category is Clinical Trial Management Software. Its primary akta.pro industry code is HLAGAJAM, Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF), with a secondary code of HLAGAAAF, Clinical Data Management, Biostatistics & Statistical Programming CROs. Its NAICS code is 541511 and its SIC code is 7372.