BioStat

What BioStat does

BioStat sp. z o.o. is a Poland-based Contract Research Organization and certified Research and Development Center (Centrum Badawczo-Rozwojowe), founded in 2005 and headquartered in Rybnik with a second office in Warsaw. The company delivers full-service clinical development to pharmaceutical, medical device, and research institution clients, covering study design and monitoring through Phase IV and post-marketing studies, alongside statistical analysis, data management, and biostatistics consulting. Named sponsors include Roche, Pfizer, AstraZeneca, Novartis, Takeda, Chiesi, Leo Pharma, Polpharma, Adamed, and Biomed Lublin, plus academic and government partners such as DKMS, Sieć Badawcza Łukasiewicz, Jagiellonian University, and the Institute of Psychiatry and Neurology Warsaw. The firm holds R&D Center status from Poland's Minister of Development and Technology and is recognized in Forbes Diamonds 2023 as one of Poland's Top 100 fastest-growing companies.

The core technology stack is built around eight proprietary software products. eCRF.biz is an FDA-compliant electronic Case Report Form system with MedDRA dictionary integration, audit trail, randomization, and drug management modules, serving as the operational backbone of clinical trial data management. Medfile is an electronic medical documentation system for clinical workflows; HaloDoctor is a 24/7 telemedicine platform offering e-Prescriptions, L4 sick leave certificates, and online psychological support; SurvGo and the CATI/CAWI/CAPI research systems deliver market and opinion research via a proprietary internet panel of over 200,000 respondents; and Labsites, MedSign, and VetFile round out care coordination, GDPR-compliant consent collection, and veterinary clinic software respectively. The eCRF system supports 21 CFR Part 11 features and the firm processes personal data under GDPR (RODO).

BioStat generates revenue from four streams: CRO professional services (clinical trial management, monitoring, biostatistics, data management), statistical analysis engagements for research and publication projects, SaaS subscriptions across the eight software products, and market research services using the consumer panel. Go-to-market is primarily direct enterprise sales to pharmaceutical and medical device buyers through the Warsaw and Rybnik offices, supplemented by inside sales to mid-market healthcare providers and self-serve SaaS onboarding for smaller clinics using SurvGo, MedSign, and Medfile. Pricing is quote-based for enterprise CRO work with unit-based pricing available for survey responses starting at 2 PLN.

Name

BioStat

Legal name

Biostat spółka z ograniczoną odpowiedzialnością

Website

https://biostat.com.pl

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) and Clinical Research Services

NAICS

Scientific Research and Development Services (5417), Custom Computer Programming Services (541511), Computer Systems Design and Related Services (54151)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Prepackaged Software (7372)

akta.pro primary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

akta.pro secondary industries

Clinical CROs (Phase I–IV) (HLAGAAAA), Biostatistics, Statistical Computing & Clinical Programming (SAS/R/Pipelines) (HLACAOAO), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF)

Keywords

• Clinical research services
• Statistical analysis
• Electronic data capture
• Telemedicine platform
• Market research services

Headquarters

HQ city

Rybnik

HQ country

Poland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. CRO Services: Full-service Contract Research Organization providing clinical trial management, monitoring, biostatistics, and data management for pharmaceutical and medical device companies.
2. Statistical Analysis: Professional statistical analysis services for research projects and scientific publications.
3. Software Subscriptions: SaaS platforms including eCRF.biz, Medfile, HaloDoctor, SurvGo, Labsites with subscription-based pricing.
4. Market Research: Market and opinion research services including CATI, CAWI, CAPI surveys, mystery shopping, focus groups.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

BioStat is a full-service Contract Research Organization (CRO) and research-and-development center delivering end-to-end clinical trial services from First-in-Human through Phase IV and post-marketing studies, including trial design, monitoring, biostatistics, and data management for pharmaceutical, biotech, and medical device sponsors. The company also provides professional statistical analysis for scientific publications and grant research, market and opinion research (CATI/CAWI/CAPI surveys, focus groups, mystery shopping) supported by a 200,000+ respondent internet panel, and develops proprietary software platforms (eCRF.biz, Medfile, haloDoctor, SurvGo, Labsites, VetFile, MedSign, CATI System) for clinical data capture, electronic medical documentation, telemedicine, and survey execution, sold via SaaS subscriptions and direct enterprise contracts.

Product overview

BioStat operates as a comprehensive CRO (Contract Research Organization) with a multi-product ecosystem spanning clinical research, market research, and healthcare technology. The portfolio consists of a unified platform with interconnected modules: the core clinical trial management suite includes eCRF.biz for electronic data capture, supplemented by MedDRA dictionary integration and FDA-compliant audit trail capabilities; the healthcare applications layer features haloDoctor (telemedicine), Medfile (EMR), Labsites (care coordination), and MedSign (consent management); the research and analytics layer encompasses SurvGo, the Internet Research Panel (200k+ respondents), and the CATI multi-mode research system; and specialized verticals include VetFile for veterinary practices and Medsupply for pharmaceutical distribution. These products share infrastructure and data capabilities, with the BioStat Research Panel providing respondent access across survey products.

Differentiator

Problem solved

Functional benefit

Brands

• HaloDoctor: Telemedicine platform for online medical consultations 24/7, featuring e-Prescription, L4 online, and psychological support services.
• Medfile
• eCRF.biz
• SurvGo
• CATI
• VetFile
• MedSign
• Labsites

Products and services

• CRO Clinical Trial Services Full-service Contract Research Organization (CRO) engagements covering clinical trial design, monitoring, biostatistics, data management, and regulatory submission support (including CTIS) for pharmaceutical, biotech, and medical device manufacturers across First-in-Human to Phase IV and post-marketing studies.
• Statistical Analysis Services Professional statistical analysis and biostatistics services for research projects, grant-funded studies, academic dissertations, and scientific publications.
• Market and Opinion Research Services Market and opinion research services delivered through CATI (telephone), CAWI (online), and CAPI (mobile) methodologies, focus groups, and mystery shopping, supported by BioStat's proprietary 200,000+ respondent internet panel.
• eCRF.biz Electronic Case Report Form (eCRF) and clinical trial data capture platform that replaces paper questionnaires with electronic data collection, supporting audit trails, data queries, MedDRA dictionary integration, and 21 CFR Part 11 controls, sold as a SaaS subscription to clinical research sponsors and CROs.
• Medfile Electronic medical documentation (EMR) system for clinics, medical practices, and healthcare facilities, supporting all medical specialists in managing patient records, documentation, and payments, sold as a SaaS subscription.
• haloDoctor Telemedicine platform providing 24/7 online medical consultations, e-Prescriptions, sick leave certificates (L4), and online psychological support services for patients and clinics, sold as a SaaS subscription.
• SurvGo Customer satisfaction, opinion, and loyalty survey application enabling users to create questionnaires and reach respondents for NPS measurement and customer experience tracking, sold as a SaaS subscription.
• Internet Research Panel (Badanie opinii) Internet survey panel with over 200,000 respondents enabling rapid online survey execution within 24 hours using consumer panel methodology, offered as a paid research service.
• Labsites E-communication platform facilitating interdisciplinary communication between laboratory, doctor, patient, and specialist, enabling clinic management workflows, sold as a SaaS subscription.
• CATI System Research software platform supporting CATI (telephone surveys), CAWI (online surveys), and CAPI (mobile-device surveys) within a single system, sold as a SaaS subscription.
• VetFile Comprehensive software for veterinary offices including medical documentation, patient records, and payment processing in one unified solution, sold as a SaaS subscription.
• MedSign Authorized consent collection service compliant with GDPR guidelines, used for signing documents and collecting patient personal data, sold as a SaaS subscription.
• Research and Academic Project Support Services Research support services for grant projects, academic research, dissertations, and scientific publications, provided under BioStat's R&D Center status, covering study design and statistical analysis.

Quantifiable outcome

• 20+ years of business and scientific experience
• +2 more outcomes

Named customers16 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature8 records

Partnerships

Two partnerships are on record, tiered core.

• Croma PharmacoreStrategic or Co-development Partner · 1 April 2026Medfile, developed by BioStat, partnered with Croma Pharma for the aesthetic medicine market. The collaboration led to the creation of Clinicore, a joint platform developed for the future of aesthetic medicine. Croma is an international pharmaceutical and aesthetic medicine company.
• Croma PharmacoreOEM/ Whitelabel/ Licensing PartnerMedfile system began collaboration with Croma for the aesthetic medicine market, providing dedicated software solutions.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Clinipace Worldwide: Mid-sized CRO offering full-service clinical development, biometrics, and regulatory affairs. Similar profile to BioStat in scale, therapeutic breadth, and reliance on biotech/mid-pharma sponsors.
• Worldwide Clinical Trials: Mid-tier CRO focused on Phase II-IV, real-world evidence, and biostatistics across multiple therapeutic areas. Comparable in size and service mix to BioStat's CRO offering and competes for similar mid-sized sponsor contracts.
• KCR: Polish-headquartered CRO providing Phase I-IV clinical trial services, biostatistics, and data management across Europe and the US. Most directly comparable peer due to shared CEE origin, full-service CRO scope, and overlapping sponsor base.
• Medpace: Mid-size, technology-forward CRO offering full-service clinical development with proprietary informatics and biostatistics platforms. Closest analog to BioStat's software-enabled CRO model, though at materially larger scale and global scope.

Broad incumbents

• Veeva Systems: Provider of Veeva Vault CDB (clinical data management) and broader life sciences cloud suite. Competes with BioStat's clinical trial software offerings and is increasingly mandated by large pharma sponsors.
• ICON plc: Global CRO providing clinical research, biometrics, and laboratory services after PRA Health Sciences merger. Overlaps with BioStat's CRO, biostatistics, and data management capabilities at significantly larger scale.
• IQVIA: Largest global CRO with broad therapeutic and geographic coverage plus technology platforms. Competes for the same tier-1 pharma clients (Pfizer, Novartis, AstraZeneca) that BioStat serves, but at global scale.
• Parexel International: Major global CRO covering Phase I-IV, real-world evidence, and regulatory consulting. Competes with BioStat for multinational pharma CRO mandates and operates its own technology stack.
• Medidata Solutions (Dassault Systèmes): Industry-standard EDC (Rave) and clinical trial platform provider. Directly competes with BioStat's eCRF.biz product in clinical data capture and is embedded within most tier-1 pharma sponsor workflows.
• SGS Health Sciences: Diversified life sciences services arm of SGS, providing clinical research, bioanalytical, and laboratory services across Europe. Overlaps with BioStat's clinical operations and lab-adjacent testing footprint in the European market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks1 record

Key highlights7 records

Customer concentration

• Xx.com/biostatteam
• Facebookfacebook.com/BioStat.Statystyka
• LinkedInlinkedin.com/company/biostat-sp--z-o-o-

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries5 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 BioStat