GKM GmbH

What GKM GmbH does

GKM Gesellschaft für Therapieforschung mbH (trading as GKM GmbH) is an independent, family-owned Contract Research Organization (CRO) headquartered at Lessingstraße 14, Munich, Germany, founded in 1981 by Siegfried K. Hippe and Renate E. Hippe. The company provides full-service clinical research services to pharmaceutical companies, medical device manufacturers, and academic institutions, operating across the full clinical development lifecycle through twelve interconnected service modules: study conception and design, medical advising and medical writing, project management, regulatory affairs, quality assurance, monitoring, data management, biostatistics, pharmacovigilance (vigilance), medical device studies, German AMNOG benefit assessments under §35a SGB V, and online GCP training for investigators.

The company's technology stack centers on conventional clinical research infrastructure — Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), electronic case report form (eCRF) solutions, and database platforms — delivered primarily through third-party vendor partnerships with Clincase and interActive Systems (secuTrial). GKM holds ISO 14155:2021-05 certification for medical device GCP, is compliant with the EU Medical Device Regulation (MDR) for medical device clinical investigations, and operates under EU Clinical Trial Regulation 536/2014 with full GDPR (DSGVO) compliance. Domain expertise spans respiratory, rheumatology, cardiology, neurology, dermatology, and gastroenterology, evidenced by a publication record of 100+ scientific outputs since 1984 and ongoing contribution to the CliNFo.EU specialist knowledge base.

GKM generates revenue through project-based contract research engagements priced per study scope, complexity, duration, and therapeutic area — a professional services model with no publicly disclosed pricing. The go-to-market motion is consultative enterprise field sales supplemented by thought-leadership content marketing (CliNFo.EU, a regular clinical research newsletter distributed via CleverReach), industry event participation, joint webinars with technology partners (e.g., Clincase on EDC systems and EU CTR), and professional network presence on LinkedIn and Xing. The project mix as of April 2026 stood at approximately 28% clinical trials, 32% non-interventional studies, 35% other projects, and 5% AMNOG-related work. Ownership remains with the Hippe family following a 2017–2018 generational succession in which founders stepped into an advisory role and professional managers — Dr. Karin Dürrstein (Managing Director from January 2018) and Rupert Lang (COO from April 2019) — assumed operational leadership alongside co-owner Sonja M. Graß.

Name

GKM GmbH

Legal name

GKM Gesellschaft für Therapieforschung mbH

Website

https://gkm-therapieforschung.de

Company type

Private

Founded year

1981

Operating status

Operating

Headcount range

101–250 employees

Short description

GKM GmbH is a Munich-based, family-owned full-service Contract Research Organization (CRO) founded in 1981, delivering clinical trial, non-interventional study, regulatory, biostatistics, and AMNOG benefit assessment services to pharmaceutical, medical device, and academic clients in Germany and Europe.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

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

SIC

Services-Commercial Physical & Biological Research (8731), Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

akta.pro secondary industries

Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA), Training & Competency Programs for GxP Compliance (HLAGAKAM), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF)

Keywords

• Contract research services
• Clinical trial management
• Pharmacovigilance services
• Biostatistics analysis
• Medical device studies

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, Infrastructure

Revenue model

1. Contract Research Services: GKM generates revenue through project-based contract research services for pharmaceutical companies, medical device manufacturers, and academic institutions. Services include clinical trials, non-interventional studies, regulatory consulting, and specialized therapeutic area expertise.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

GKM GmbH is a full-service Contract Research Organization that conducts and supports clinical trials, non-interventional studies, and regulatory submissions for the pharmaceutical industry, medical device manufacturers, and academic institutions. Its integrated service portfolio spans concept development, medical advising and writing, project management, regulatory affairs, quality assurance, monitoring, data management, biostatistics, pharmacovigilance, medical device studies, AMNOG benefit assessment, and online GCP training for investigators. Services are delivered on a project-based contract basis across Germany and internationally.

Product overview

GKM GmbH is a full-service Contract Research Organization (CRO) offering comprehensive clinical research services throughout the entire drug and medical device development lifecycle. The company provides an integrated service portfolio comprising 12 interconnected modules: Concept Development, Medical Advising and Medical Writing, Project Management, Regulatory Affairs, Quality Assurance, Monitoring, Data Management, Biostatistics, Vigilance, Medical Devices, AMNOG Benefit Assessment, and Online GCP Training for Investigators. These services support clinical trials, non-interventional studies, and regulatory submissions for the pharmaceutical industry, medical device manufacturers, and academic institutions.

Differentiator

Problem solved

Functional benefit

Products and services

• Concept Development (Konzeption und Designentwicklung) Study design and protocol development services for clinical research projects, supporting sponsors and academic investigators from initial concept through executable protocols.
• Medical Advising and Medical Writing Medical consultation and scientific documentation services for pharmaceutical, medical device, and academic sponsors, covering clinical study reports, regulatory submissions, and scientific communications.
• Project Management (Projektmanagement) Comprehensive project coordination and management services for clinical trials and non-interventional studies delivered by GKM.
• Regulatory Services Regulatory affairs support including trial submissions, approvals, and compliance with EU Clinical Trial Regulation 536/2014 (CTR) for pharmaceutical and academic sponsors.
• Quality Assurance (Qualitätssicherung) Quality assurance services ensuring compliance with Good Clinical Practice (GCP) standards and regulatory requirements across clinical trials and non-interventional studies.
• Monitoring Clinical monitoring services including on-site monitoring, source data verification, and risk-based quality management for clinical trials and non-interventional studies.
• Data Management (Datenmanagement) Custom electronic Case Report Form (eCRF) and database solutions for clinical trial data collection and management, supporting both clinical trials and non-interventional studies.
• Biostatistics (Biostatistik) Study objective-oriented statistical planning and analysis services for clinical research, covering design, sample size, analysis plans, and reporting.
• Pharmacovigilance (Vigilanz) Pharmacovigilance services including adverse event (AE) and serious adverse event (SAE) management delivered to client specifications across clinical trials and post-marketing studies.
• Medical Device Clinical Investigations (Medizinprodukte) Specialized clinical investigation services for medical devices, including PMCF (Post-Market Clinical Follow-up) studies and EU Medical Device Regulation (MDR) compliance work, conducted under DIN EN ISO 14155:2021-05.
• AMNOG Benefit Assessment (Nutzenbewertung gemäß § 35a SGB V) Early benefit assessment services for the German AMNOG process under § 35a SGB V, including dossier preparation and endpoint selection to support market access for pharmaceutical products.
• Online GCP Training for Investigators (Online GCP-Schulung für Prüfer) Online Good Clinical Practice (GCP) training course designed for clinical investigators participating in trials supported by GKM.

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature2 records

Partnerships

Two partnerships are on record, tiered core and minor.

• BVMA (Bundesverband Medizinischer Auftragsinstitute e.V.)coreOthers · 1 October 2017GKM is a member of BVMA, the German industry association for Contract Research Organisations. Membership provides access to regulatory updates, industry representation, networking opportunities, and collective advocacy with regulatory authorities. GKM joined the association in 2017.
• Ärzte der Welt e.V. (Doctors of the World Germany)minorStrategic or Co-development PartnerCharitable organization providing free medical care to uninsured people. GKM supports the open.med project with software development expertise for patient documentation systems (secuTrial), enabling better medical and social documentation for patients lacking health insurance access.

Scale indicators3 records

Recent moves4 records

Expansion highlights4 records

Broad incumbents

• ICON plc: Global full-service CRO offering clinical trial, biostatistics, data management, and laboratory services. Directly comparable offering to GKM across the clinical development lifecycle, but with global reach and substantially larger scale.
• Syneos Health: Global biopharma solutions organization offering clinical development and commercial services. Directly comparable clinical research service portfolio to GKM, but with global infrastructure and a broader commercial services overlay.
• IQVIA: Global mega-CRO and life sciences technology company. Comparable as a full-service clinical research services provider serving pharmaceutical and medical device sponsors across all major geographies; competes with GKM on large multi-region programs but operates at vastly larger scale.
• Parexel International: Global full-service CRO with deep expertise in regulatory affairs, clinical trials, and market access (including AMNOG support in Germany). Directly comparable to GKM on full-service delivery and particularly on regulatory/AMNOG capabilities, but at global scale.
• Charles River Laboratories: Global CRO spanning preclinical, clinical, and manufacturing services. Comparable to GKM in clinical research service offering and biopharma sponsor relationships, but with materially broader portfolio and earlier-stage focus.
• SGS Health Sciences (SGS Clinical Research): Diversified life sciences services provider offering clinical research, bioanalytical, and pharmaceutical services. Comparable to GKM on clinical trial and bioanalytical capabilities, with broader parent group scale and global reach.

Direct peers

• Medpace: Mid-to-large full-service CRO focused on small and mid-sized biopharma sponsors. Comparable to GKM in full-service clinical trial execution, biostatistics, and regulatory support — competing most directly for the same segment of European and global mid-size pharma trials.
• KCR CRO Group: European-headquartered mid-sized full-service CRO with operations across Eastern and Western Europe. Comparable to GKM in full-service portfolio, therapeutic breadth, and focus on European mid-sized biopharma and device sponsors.
• Worldwide Clinical Trials: Mid-sized global CRO offering full-service clinical trial, biostatistics, and pharmacovigilance services. Closely comparable to GKM in size segment, service portfolio scope, and target customer base of mid-sized biopharma sponsors.
• FGK Clinical Research GmbH: Munich-headquartered mid-sized European CRO offering full-service clinical trial services. Highly comparable to GKM in geography (Germany), service portfolio, customer base (European pharma and medical device), and company size segment.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/gkm-gesellschaft-fuer-therapieforschung-mbh

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 GKM GmbH