Universität Leipzig, Zentrum für Klinische Studien (ZKS) Leipzig

What Universität Leipzig, Zentrum für Klinische Studien (ZKS) Leipzig does

Zentrum für Klinische Studien (ZKS) Leipzig is a non-profit academic clinical trial coordination center operating as a central institution of the Medical Faculty at Leipzig University. Founded in 1999 with Federal Ministry of Education and Research (BMBF) funding, ZKS provides full-cycle support ("from A to Z") for both investigator-initiated trials (IITs) and commercial clinical trials conducted at Leipzig University Medical Centre (UML). It serves academic physicians and scientists at UML (for whom services are free when pursuing third-party funding), industrial sponsors seeking site management for trials at UML, and public institutions, professional societies, and self-help groups initiating studies. Over 50 staff across biometrics, project management, data management, quality management, pharmacovigilance, and monitoring staff the center under Managing Director Dr. Oana Brosteanu.

Name

Universität Leipzig, Zentrum für Klinische Studien (ZKS) Leipzig

Legal name

Zentrum für Klinische Studien Leipzig (ZKS Leipzig)

Website

https://zks.uni-leipzig.de

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

1–10 employees

Short description

ZKS Leipzig is the academic clinical trial coordination center at Leipzig University Medical Centre, providing biometrics, data management, monitoring, pharmacovigilance, and regulatory support for investigator-initiated and commercial trials, plus the ZKS Academy training portfolio.

Ownership category

akta.pro rank

Product category

Clinical Research Services

NAICS

Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Trial Site Operations & Study Coordination (HLAGACAE)

akta.pro secondary industries

Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG), Investigator & Site Training / GCP Support (HLAGACAF), Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA)

Keywords

• Clinical trial coordination
• Investigator-initiated trials
• Clinical research training
• GCP qualification courses
• Biostatistics consulting

Headquarters

HQ city

Leipzig

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure, Others

Revenue model

1. Third-Party Funded Research (DFG, BMBF, Deutsche Krebshilfe): ZKS Leipzig supports scientists and physicians of the University Medical Centre Leipzig in applying for and managing third-party funded clinical trials. Funding is obtained from DFG (German Research Foundation), BMBF (Federal Ministry of Education and Research), Deutsche Krebshilfe (German Cancer Aid), and EU Horizon Europe/Horizon 2020 programmes. Services for UML researchers seeking public funding are free of charge.
2. Fee-for-Service Training (Academy): The ZKS Academy generates revenue through continuing education courses and the part-time Master's programme MSc Clinical Research & Translational Medicine. Course fees range from 150 EUR (discounted) to 2,500 EUR (full), with the Master programme having separate tuition fees. This represents a direct revenue stream from participants and their employers.
3. Site Management Services for Industrial Partners: ZKS provides site management services to commercial/industrial sponsors conducting clinical trials at Leipzig University Medical Centre, including quality management, staff training, feasibility management, visit planning, and patient recruitment support. Revenue is generated through service contracts with pharmaceutical and medical device companies.

Pricing tiers

Go-to-market motion1 record

Distribution channels6 records

Marketing channels7 records

Core offering

ZKS Leipzig provides full-cycle clinical trial coordination services for investigator-initiated trials (IITs) and commercial trials conducted at Leipzig University Medical Centre, covering study planning, biostatistics, data management, monitoring, pharmacovigilance, quality management, regulatory affairs, and project management. It also operates the ZKS Academy, which delivers GCP-compliant certificate courses for investigators and study personnel as well as a part-time M.Sc. programme in Clinical Research & Translational Medicine, with the overarching value proposition of A-to-Z clinical trial support.

Product overview

ZKS Leipzig operates as a central institution of the Medical Faculty of Leipzig University, providing comprehensive clinical trial coordination services. Its core offering consists of end-to-end study support services (covering study planning, biostatistics, data management, monitoring, pharmacovigilance, and project management) for both academic-initiated and commercial trials. The ZKS Akademie serves as the educational umbrella brand encompassing certificate training courses (basic, advanced, refresher, and update courses for investigators, study assistants, and study leaders) and the M.Sc. Clinical Research & Translational Medicine postgraduate programme. An additional programmatic offering is the 'Clinical Trialists of Tomorrow' workshop format, which provides intensive, multidisciplinary mentorship for clinicians developing study proposals. Together, these offerings span the full lifecycle of clinical research — from study concept development through regulatory submission, execution, and the formal qualification of the personnel who conduct trials.

Differentiator

Problem solved

Functional benefit

Brands

• ZKS-Akademie: Academy offering continuing education courses for clinical research personnel including basic, advanced, and refresher courses for investigators, as well as study nurse training and the part-time Master's programme Clinical Research & Translational Medicine
• Clinical Trialists of Tomorrow
• Grundlagenkurs (CTR/MDR/IVDR)
• Aufbaukurs (CTR/MDR/IVDR)
• Auffrischungskurs (CTR/MDR/IVDR)
• M.Sc. Clinical Research & Translational Medicine

Quantifiable outcome

• 92% publication rate of clinical trial results in the EU database (EUCTR) by University of Leipzig
• +4 more outcomes

Named customers6 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature3 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• KKS-Netzwerk e.V. (Koordinierungszentren für Klinische Studien)coreStrategic or Co-development PartnerZKS Leipzig is a founding member of the KKS-Netzwerk, an association uniting Clinical Trial Coordination Centres (KKS) and Clinical Trial Centres (ZKS) across Germany. The network's goal is to strengthen patient-oriented clinical research in Germany. ZKS participates in network-wide training programmes and shares best practices across member centres.
• ECRIN (European Clinical Research Infrastructure Network)coreStrategic or Co-development PartnerECRIN is a European public non-profit organisation linking scientific partners and networks across Europe to facilitate multinational clinical research. ZKS Leipzig holds ECRIN Datacenter Certification (2019), confirming compliance with 115 IT and data management standards. ZKS provides data management and clinical trial support services through the ECRIN network for multinational trials.
• IMISE (Institut für Medizinische Informatik, Statistik und Epidemiologie)coreTechnology or IntegrationIMISE is an institute within the Medical Faculty of Leipzig University. ZKS emerged from IMISE (which celebrated its 30th anniversary in 2024), and both institutions share the same building and close collaborative ties. IMISE provides research expertise in medical informatics, clinical studies and biometric modelling, bioinformatics and systems biology. The ZKS website is technically maintained in collaboration with IMISE.
• TMF e.V. (Technologie- und Methodenplattform für die vernetzte medizinische Forschung)minorStrategic or Co-development PartnerTMF is a technology and methods platform for networked medical research. ZKS Leipzig is an active member and important cooperation partner in TMF's national joint research projects.
• PAPAartis International Research ConsortiumcoreStrategic or Co-development PartnerPAPAartis is an international research project on risk reduction before aortic aneurysm surgery, coordinated by Leipzig University. The project involves 33 research partners from 11 European countries including 10 leading European aortic centres and 2 top US centres. ZKS Leipzig provides project management, data management, and biometric support for the associated randomised clinical trial on MISACE spinal cord protection.
• Beta3_LVH International Research ConsortiumcoreStrategic or Co-development PartnerBeta3_LVH is an EU Horizon 2020-funded international research project (12 partners in 8 European countries) investigating whether the drug Betmiga can prevent progression of heart failure in patients with left ventricular dysfunction. Led by KU Leuven, Belgium. ZKS Leipzig (as KKS) provides project and data management and biometric support for the clinical trial.
• ADAMON Project (Risk-Adapted Monitoring Strategies)minorStrategic or Co-development PartnerADAMON was a BMBF-funded prospective study investigating whether risk-adapted monitoring is as effective as intensive monitoring in clinical trials. 11 non-commercial clinical trials were included from 2008. The project demonstrated that risk-based monitoring requires less than 50% of resources compared to intensive monitoring while achieving equivalent results. ZKS Leipzig project leadership: Dr. Oana Brosteanu.
• EuroNet Paediatric Hodgkin's Lymphoma Group (EuroNet-PHL)minorStrategic or Co-development PartnerEuroNet-PHL is a European network for paediatric Hodgkin's lymphoma clinical trials. ZKS Leipzig is an active cooperation partner in this international research collaboration.
• SepNet Study GroupminorStrategic or Co-development PartnerSepNet is a study group focused on sepsis research, funded by the Sepsis Foundation. ZKS Leipzig is listed as a cooperation partner on the ZKS website's cooperation page.
• Saxocell (Universitäres Krebszentrum Leipzig / Leipzig University Cancer Centre)minorStrategic or Co-development PartnerSaxocell is the University Cancer Centre Leipzig. ZKS and Saxocell jointly organised information events to explain how ZKS supports clinicians in conducting clinical trials. The collaboration aims to encourage and support cancer researchers at UML to develop and submit clinical trial proposals.
• IFB Adiposity (Integrated Research and Treatment Centre for Obesity Diseases)minorStrategic or Co-development PartnerIFB Adiposity is an integrated research and treatment centre for obesity diseases at Leipzig University. ZKS Leipzig is listed as an active cooperation partner in IFB's research projects, providing clinical trial expertise.
• FIND-AF2 Consortium (51 Study Sites Nationwide)coreStrategic or Co-development PartnerFIND-AF2 is a major German multicentre clinical trial (51 sites, 5,200 patients, 13.8 million EUR DFG funding, led by Prof. Dr. Rolf Wachter, UKL Cardiology) investigating intensive cardiac rhythm monitoring to detect atrial fibrillation in stroke patients. ZKS Leipzig provides comprehensive study management including data management, biometrics, monitoring, and regulatory support.

Scale indicators12 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• ZKS Dresden (KKS Dresden, University Hospital Carl Gustav Carus): Dresden's academic Clinical Trial Centre with parallel offering across biometrics, data management, monitoring, and IIT support. Regional peer in Saxony with overlapping services.
• IKF Mainz (Interdisziplinäres Zentrum Klinische Studien, University Medical Center Mainz): Mainz's academic clinical trial centre offering comparable study coordination, biometrics, and monitoring services to university researchers and industry sponsors.
• KKS Charité Berlin (Charité – Universitätsmedizin Berlin): Berlin's equivalent academic Clinical Trial Coordination Centre within Charité, providing data management, biometrics, monitoring, and IIT support. Directly comparable in scope, scale, and academic-CRO model.
• KKS Heidelberg (Heidelberg University Hospital): Academic KKS serving Heidelberg University Hospital with comparable services (study coordination, biometrics, monitoring, training). Direct peer in the German KKS-Netzwerk.

Broad incumbents

• Parexel International: Global commercial CRO offering full-service clinical trial management. Comparable in functional capabilities (monitoring, data management, biometrics) but competing in the commercial sponsor segment ZKS serves.
• KKS-Netzwerk e.V. National association of all German KKS/ZKS centres. ZKS is a founding member; the network itself is the umbrella for academic clinical-trial coordination in Germany and shapes competitive context.
• ECRIN (European Clinical Research Infrastructure Network): European non-profit coordinating multinational clinical trial infrastructure. ZKS is ECRIN-certified and provides data management services through this network — a comparable supra-institutional body.
• CTSU Oxford (Clinical Trial Service Unit, University of Oxford): Internationally renowned academic clinical-trial coordination and epidemiology unit. Comparable in delivering large-scale investigator-initiated trials and methodological leadership across multiple therapeutic areas.
• TMF e.V. (Technologie- und Methodenplattform für die vernetzte medizinische Forschung): German technology/methods platform for networked medical research; ZKS lists TMF as a cooperation partner. Adjacent governance/standards body shaping academic clinical-research practice.

Regional players

• Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM): German contract research organization with preclinical/clinical trial capabilities. Comparable in offering applied clinical research services to sponsors, though with a different ownership structure and broader translational scope.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/zentrum-f%C3%BCr-klinische-studien-zks-leipzig---akademie

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Universität Leipzig, Zentrum für Klinische Studien (ZKS) Leipzig