BioResearch Group Sp. z o. o.

What BioResearch Group Sp. z o. o. does

BioResearch Group Sp. z o. o. is a privately held Polish limited liability company founded in 2016 and headquartered in Warsaw, operating a dedicated early-phase clinical research site in Kajetany (within hospital premises near Nadarzyn) for biotech, pharmaceutical, and CRO clients. The site delivers Phase I clinical trial services — including First-in-Human (FIH), Single Ascending Dose (SAD), and Multiple Ascending Dose (MAD) studies — together with bioequivalence and bioavailability studies, vaccine trials, and specialized work in tobacco/nicotine harm reduction and metabolic, inflammatory, and respiratory therapeutics. Infrastructure consists of a clinic, sample collection rooms, an internal pharmacy, an on-site GCLP-accredited laboratory, and a coordination room embedded in hospital premises, enabling integrated execution under a hospital safety envelope.

The company operates a project-based professional services model, generating revenue through tailored clinical trial contracts that span protocol design, study start-up, conduct, and final study report. Pricing is quote-based and not publicly disclosed. The go-to-market motion is enterprise field sales: direct engagement with pharmaceutical and biotech sponsors, participation in industry conferences (notably BIO-Europe), and long-term co-development partnerships with Polish pharmaceutical companies including Celon Pharma S.A. Supporting capabilities include regulatory credentials (GCLP accreditation No 06019 from Qualogy Ltd, 2019; TransCelerate GCP accreditation, 2019; GcLP quality certificate, 2022; successful FDA inspection, 2025) and ongoing GMP certification work for pharmaceutical procedures.

Leadership comprises Dr Katarzyna Jarus-Dziedzic (CEO and Principal Investigator; 25+ years, 300+ studies) and Dr Jarosław Długołęcki (Medical Expert; 16 years, ex-PAREXEL Berlin). The organization has approximately 15 employees and has completed 44 studies enrolling roughly 5,000 patients cumulatively, with additional pandemic-era COVID-19 testing of approximately 2,500 patients. The firm holds no disclosed venture capital or private equity ownership and operates as an independent site serving global and Polish pharma clients from a single integrated facility.

Name

BioResearch Group Sp. z o. o.

Legal name

BioResearch Group Sp. z o. o.

Website

https://bioresearch.pl

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

BioResearch Group is a privately held Polish Phase I clinical research site conducting First-in-Human, bioequivalence, bioavailability, and specialized trials for biotech, pharmaceutical, and CRO clients from a GCLP-accredited, FDA-inspected facility within hospital premises near Warsaw.

Ownership category

akta.pro rank

Product category

Early Phase Clinical Research Services

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Trial Sample Collection & Site Phlebotomy Services (HLAGACAJ)

akta.pro secondary industries

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Sample Logistics, Biorepository & IVD Kit Management (Trial Support) (HLAGAEAI), Clinical Site Start-Up & Activation (Regulatory/Ethics/Contracts) (HLAGACAC)

Keywords

• Early phase clinical trials
• Bioequivalence studies
• Bioavailability studies
• Phase I clinical trials
• Clinical trial management

Headquarters

HQ city

Warsaw

HQ country

Poland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Trial Services: Full-service clinical trial execution including protocol design, study start-up, conduct, and final study report. Services cover medical, laboratory, pharmaceutical procedures, and study administration. Revenue generated through project-based contracts with pharma, biotech, and CRO clients.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

BioResearch Group is a dedicated clinical site conducting early phase (Phase I) clinical trials — including First-in-Human (FIH), Single Ascending Dose (SAD), and Multiple Ascending Dose (MAD) studies — as well as bioequivalence and bioavailability studies for biotech, pharma, and CRO companies. The company provides full tailor-made clinical trial services from protocol design, study start-up, conduct, and final study report, supported by a dedicated space within hospital premises that includes a clinic, sample collection rooms, internal pharmacy, laboratory, and coordination room. Services are delivered under GCLP, GCP, and FDA-compliant quality standards.

Product overview

BioResearch Group Sp. z o. o. is a dedicated clinical research site offering integrated early phase clinical trial services. The company operates as a single unified service offering encompassing Phase I clinical trials (FIH, SAD, MAD), bioequivalence and bioavailability studies, and full clinical trial management from protocol design through final study report. The portfolio includes specialized services for vaccine trials, tobacco/nicotine product studies, and therapeutic areas such as diabetes, oncology, immunology, and respiratory diseases. All services are delivered from a GCLP-accredited facility within hospital premises, featuring dedicated clinical, laboratory, pharmacy, and coordination infrastructure.

Differentiator

Problem solved

Functional benefit

Products and services

• Early Phase Clinical Trials (Phase I – FIH, SAD, MAD) Comprehensive Phase I clinical trial services including First-in-Human (FIH), Single Ascending Dose (SAD), and Multiple Ascending Dose (MAD) studies delivered from a dedicated hospital-based facility for biotech, pharma, and CRO sponsors.
• Bioequivalence and Bioavailability Studies Bioequivalence and bioavailability studies for biotech, pharma, and CRO companies to demonstrate therapeutic equivalence of pharmaceutical formulations, including generic and innovative drug development programs.
• Clinical Trial Management Services Full clinical trial services from protocol design, study start-up, conduct, and final study report, covering medical, laboratory, pharmaceutical procedures, administration, and study management for sponsor clients.
• GCLP Laboratory Services Good Clinical Laboratory Practice accredited laboratory services including sample processing, handling, and analysis with certified quality management systems, delivered from BRG's internal laboratory facility.
• Vaccine Clinical Trials Early phase vaccine clinical trials including First-in-Human vaccine studies with specialized requirements for immunogenicity assessment and GMP-compliant product preparation.
• Tobacco and Nicotine Product Studies Comprehensive tobacco-related studies including safety, exposure, pharmacokinetic, and user-behaviour assessments for e-cigarettes, nicotine pouches, and heat-not-burn (HnB) devices.
• COPD and Smoking Risk Studies Clinical studies assessing health outcomes in patients with chronic obstructive pulmonary disease (COPD) and research on harm reduction from alternative nicotine delivery systems.

Quantifiable outcome

• 44 studies completed and 5000 patients enrolled

Named customers2 records

Segments3 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature3 records

Partnerships

Seven partnerships are on record, tiered minor and core.

• Medical Research Agency (Poland)minorStrategic or Co-development Partner · 10 January 2024Celon Pharma study conducted at BRG was co-financed by the Medical Research Agency, supporting innovative therapy development.
• Celon Pharma S.A.coreStrategic or Co-development Partner · 28 September 2020BioResearch Group collaborates with Celon Pharma on testing new, innovative therapies. Over 4 years, BRG conducted early-phase studies for drugs in areas including neuropsychiatry, oncology, metabolic diseases, and inflammatory diseases. BRG participated in the official opening of Celon Pharma's 30,000+ m2 R&D Center.
• Qualogy LtdminorOthers · 1 February 2019Qualogy Ltd issued GCLP accreditation to BRG following assessment on February 26-27, 2019.
• Polish Society of Clinical Trials (GCPpl)minorOthers · 24 May 2018BRG team actively participates in conferences organized by the Polish Society of Clinical Trials, including International Clinical Trials Day events.
• Polish Pharmaceutical CompaniescoreStrategic or Co-development Partner · 28 February 2018BRG conducts studies for Polish pharmaceutical companies, including bioequivalence studies for inhalation drugs and First-in-Human studies for innovative antidiabetic therapies.
• Society for Clinical Research Sites (SCRS)minorOthers · 24 January 2018BRG is registered as a member of SCRS since January 2018, the world's foremost advocacy organization supporting the clinical research community.
• NCBiR (National Centre for Research and Development, Poland)coreStrategic or Co-development Partner · 15 November 2017BRG won a tender for an innovative Phase 1 project co-funded by NCBiR, including First-in-Man studies for psychiatric drugs as part of the NCBiR programme.

Scale indicators4 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Quotient Sciences: UK-based early-phase CRO focused on FIH clinical pharmacology and integrated drug development services including 14C-labeled and formulation work — overlapping Phase I mandate with BRG.
• Celerion: Specialized early-phase (Phase I) clinical research organization offering FIH, SAD/MAD, and bioequivalence studies from dedicated clinical pharmacology units — the closest direct analogue to BRG's positioning.
• Altasciences: Early-phase CRO with multiple dedicated clinical pharmacology units in North America running FIH/SAD/MAD and bioequivalence studies — directly comparable Phase I service mix to BRG.
• Nuvisan: European CRO with Phase I clinical pharmacology capabilities and integrated bioanalytical labs — comparable in early-phase and laboratory service scope to BRG.
• Biotrial: European Phase I specialist with dedicated clinical pharmacology units conducting FIH, SAD/MAD, and bioequivalence studies for pharma and biotech — comparable in scope and customer base to BRG.
• CRS Clinical Research Services: Germany-based early-phase CRO operating dedicated Phase I and bioequivalence units with hospital-integrated infrastructure — closely mirrors BRG's hospital-embedded, Phase I-focused model in continental Europe.

Broad incumbents

• Eurofins Scientific: Global testing group with central laboratory and clinical trial bioanalytical services — adjacent peer that competes for the bioanalytical/sample-analysis portion of Phase I programs and serves similar sponsors.
• Parexel International: Large global CRO with dedicated Phase I units alongside later-phase services — competes with BRG for Phase I studies but offers a much broader full-development portfolio.
• IQVIA: World's largest CRO with extensive early-phase clinical pharmacology capacity — overlaps with BRG in Phase I but serves sponsors globally with end-to-end development capabilities.

Regional players

• SciencePharma: Poland-based CRO offering clinical trial, bioequivalence, and regulatory services — regional peer serving the same Polish pharma and biotech customer base as BRG.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/bioresearch-group-sp-z-o-o

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 BioResearch Group Sp. z o. o.