FGK Clinical Research GmbH

What FGK Clinical Research GmbH does

FGK Clinical Research GmbH is a Munich-headquartered, owner-operated contract research organization (CRO) founded in 2002 that delivers full-service clinical development and consulting to pharmaceutical, biotechnology, and medical device sponsors. The firm operates within the FGK Group, which also includes FGK Representative Services (EU regulatory representation) and FGK Pharmacovigilance as affiliated entities, enabling cross-sell of regulatory and PV capabilities to the same sponsor base. With 101-250 employees and German private-company domicile, FGK positions itself as a mid-size alternative to large CROs, combining end-to-end coverage with the flexibility of dedicated small project teams.

The company's service offering is structured as twelve interconnected modules that span the clinical trial lifecycle: Consulting, Representative Services, Regulatory Affairs, Medical Writing, Project Management/Monitoring, Quality Assurance, Clinical Data Management, Clinical Trial Biostatistics, Medical Safety, Pharmacovigilance, eSolutions (electronic data capture and trial technology), and Biotech Contract Research. FGK applies this platform across 14 therapeutic areas including Medical Devices, Advanced Therapy Medicinal Products (ATMP), Oncology, Neurology/Psychiatry, Dentistry, Cardiovascular, Infections, Ophthalmology, Pneumology, Gastroenterology, Gynecology/Urology, Endocrine/Metabolic Disorders, Dermatology, and Rare Diseases. The "eSolutions" line represents the firm's primary technology layer, offering electronic data capture and clinical trial data management; no proprietary AI/ML capability, API, or SDK is disclosed.

FGK generates revenue through project-based professional services contracts with sponsors across its three primary customer segments (pharmaceutical, biotechnology, and medical device companies), with pricing handled on a per-project quote basis and not publicly disclosed. The go-to-market is sales-led and direct, leveraging LinkedIn and the firm's website (with News & Events and a Knowledge Hub) for top-of-funnel visibility. No external funding, parent company, public listing, or acquisition history is indicated in the source data, and the firm describes itself as flexible, efficient, and owner-driven — a positioning aimed at mid-cap sponsors that need full-service coverage without the overhead of a large CRO engagement.

Name

FGK Clinical Research GmbH

Legal name

FGK Clinical Research GmbH

Website

https://fgk-cro.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

101–250 employees

Short description

FGK Clinical Research GmbH (FGK CRO) is a Munich-based, owner-operated contract research organization founded in 2002, delivering full-service clinical development and consulting to pharmaceutical, biotechnology, and medical device sponsors across 14 therapeutic areas.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA)

Keywords

• Contract research organization
• Clinical development services
• Regulatory affairs services
• Pharmacovigilance services
• Clinical trial monitoring

Headquarters

HQ city

Munich

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: Project-based contract research services for pharmaceutical, biotechnology, and medical device companies spanning consulting, regulatory affairs, medical writing, project management, monitoring, quality assurance, clinical data management, biostatistics, medical safety, pharmacovigilance, and eSolutions.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

FGK Clinical Research GmbH operates as a full-service contract research organization (CRO), providing clinical development and consulting services to pharmaceutical, biotechnology, and medical device sponsors. Its portfolio spans the entire clinical trial lifecycle — consulting, regulatory affairs, medical writing, project management and monitoring, quality assurance, clinical data management, biostatistics, medical safety, pharmacovigilance, electronic solutions (eSolutions), and biotech-specific contract research — delivered through small, dedicated, owner-driven teams.

Product overview

FGK Clinical Research GmbH operates as a full service contract research organization (CRO) offering a unified platform of clinical development and consulting services to pharmaceutical, biotechnology, and medical device companies. The service portfolio includes twelve interconnected modules spanning the entire clinical trial lifecycle: Consulting, Representative Services, Regulatory Affairs, Medical Writing, Project Management/Monitoring, Quality Assurance, Clinical Data Management, Clinical Trial Biostatistics, Medical Safety, Pharmacovigilance, eSolutions, and Biotech Contract Research. These services are designed to be flexibly tailored to client needs, supporting studies from early-phase research through post-market surveillance across multiple therapeutic areas.

Differentiator

Problem solved

Functional benefit

Products and services

• Consulting Expert consulting services for clinical development and regulatory strategy, supporting pharmaceutical, biotechnology, and medical device sponsors in designing and executing clinical programs.
• Representative Services Representation services for sponsors in regulatory and clinical matters, acting on behalf of the sponsor with health authorities and within EU regulatory frameworks.
• Regulatory Affairs Regulatory affairs support including submissions and compliance with health authorities for drugs, biologics, ATMPs, and medical devices.
• Medical Writing Professional medical writing services for clinical study reports, protocols, investigator brochures, and regulatory submission documents.
• Project Management / Monitoring Comprehensive clinical project management and on-site clinical trial monitoring (CRA) services across multi-phase studies for sponsors.
• Quality Assurance Quality assurance services ensuring compliance with GCP, GMP, and regulatory standards across clinical trial operations.
• Clinical Data Management Management of clinical trial data including collection, validation, database build, and data cleaning services.
• Clinical Trial Biostatistics Biostatistical analysis, statistical programming, and study design support for clinical trials across therapeutic areas.
• Medical Safety Medical safety monitoring and pharmacovigilance services for clinical studies, including adverse event review and reporting.
• Pharmacovigilance Post-marketing and clinical trial pharmacovigilance services, including case processing, aggregate reporting, and safety database management.
• eSolutions Electronic solutions and technology services for clinical trial data capture, management, and reporting as part of FGK's clinical trial technology stack.
• Biotech Contract Research Specialized contract research services tailored for biotechnology companies developing biologics, cell therapies, and ATMPs.

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Recent moves4 records

Expansion highlights4 records

Direct peers

• Celerion: Mid-size CRO with strong early-phase clinical pharmacology and biopharmaceutics services serving pharma and biotech. Comparable scale and biotech/biopharma client mix to FGK.
• Medpace Holdings: Mid-size, US-headquartered full-service CRO focused on small/mid-cap biotech sponsors. Highly comparable business model (full-service clinical development, project-based pricing, therapeutic specialization) and similar positioning around agile, high-touch delivery versus mega-CROs.
• Worldwide Clinical Trials: Mid-tier global CRO offering Phase I-IV clinical development, biostatistics, and pharmacovigilance services to pharma and biotech. Comparable scale and service breadth to FGK with a similar specialty/biotech focus.
• PSI CRO: Privately-held European-headquartered full-service CRO with similar mid-size footprint and full clinical development service offering. Closest head-to-head European comparable for FGK's positioning.
• Premier Research: Mid-size global CRO with strong specialty in biotech, rare disease, oncology, and medical device trials — directly overlapping with FGK's stated therapeutic expertise and mid-tier service profile.

Broad incumbents

• ICON plc: One of the world's largest CROs offering full clinical development, lab, and consulting services globally. A broad incumbent that overlaps with FGK across most service lines but operates at far greater scale and global footprint.
• IQVIA: Largest global CRO and life sciences services provider with deep clinical, data, and technology capabilities. Overlaps with FGK's clinical development and consulting services but with vastly greater scale, tech, and geographic reach.
• Parexel International: Large global CRO offering full-service clinical development with particular strength in biotech and rare disease — directly overlapping with several of FGK's stated therapeutic areas.
• Charles River Laboratories: Major life-sciences research organization with clinical CRO, preclinical, and manufacturing services. Comparable to FGK in clinical/biotech support, but operates at significantly larger scale and across additional life-science adjacencies.

Emerging players

• Lindus Health: Tech-enabled CRO specializing in decentralized and digitally-run clinical trials for biotech sponsors. Comparable target customer (biotech sponsors seeking agile CROs) but differentiated by technology-first delivery model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/fgk-clinical-research-gmbh

Revenue estimate

Valuation estimate

Number of profiles

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 FGK Clinical Research GmbH