GKM Gesellschaft für Therapieforschung mbH

Your full-service CRO in Germany for clinical research with drugs and medical devices

Clinical Research Services for international and national clinical trials and non-interventional studies

Monitoring2025-04-08T12:52:01+02:00
Monitoring

Monitoring

Regulatory2025-04-08T12:52:35+02:00
Regulatory

Regulatory

Project management2025-04-08T12:53:03+02:00
Project management

Project management

Medical Advising and Medical Writing2025-04-08T12:53:37+02:00
Medical Advising and Medical Writing

Medical Advising and Medical Writing

Concept Development2025-04-08T12:54:07+02:00
Concept Development

Concept Development

Quality Assurance2025-04-08T12:54:40+02:00
Quality Assurance

Quality Assurance

Data Management2025-04-08T12:55:28+02:00
Data Management

Data Management

Biostatistics2025-04-08T12:55:59+02:00
Biostatistics

Biostatistics

Vigilance2025-04-08T12:57:58+02:00
Vigilance

Vigilance

Medical Devices2025-04-08T13:01:31+02:00
Medical Devices

Medical Devices

Benefit Assessment according to § 35 a SGB V2025-04-10T14:31:09+02:00
Benefit Assessment according to § 35 a SGB V

Benefit Assessment according to § 35 a SGB V

CLINICAL RESEARCH ORGANIZATION (CRO)

As a Contract Research Organization since 1981, GKM stands for flexibility, continuity and quality while planning, managing and realizing your clinical trial or non-interventional study. >> More about us

MEDICAL ADVANCEMENT THROUGH EFFECTIVE RESEARCH

36 years of experience in clinical research with clinical trials and non-interventional studies involving over 800 national and international projects with drugs and medical devices. >> More about our projects

Newsletter Clinical Research

For smart decision makers in the pharma and medical device industry Receive up-to-date information and insights on truly relevant topics in clinical research!

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Are you planning a study? Feel free to request our study planner for Clinical Trials (CS) and Non-Interventional Studies (NIS)!

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Planer NIS

Latest Articles, Publications & Events

Newest articles

Please note that for our specialist articles you will be redirected to knowledge base for clinical research “CliNFo.EU”.

IMPs vs. AxMPs: What’s the Difference and Why Does It Matter?

IMPs vs. AxMPs: What’s the Difference and Why Does It Matter?

In clinical trials, distinguishing between Investigational Medicinal Products (IMPs) and Auxiliary Medicinal Products (AxMPs or AMPs) is essential for regulatory compliance, robust trial design, and patient safety.
Das Forschungsdaten­zentrum Gesundheit – eine neue Datengrundlage fürs AMNOG Verfahren?

Das Forschungsdaten­zentrum Gesundheit – eine neue Datengrundlage fürs AMNOG Verfahren?

Mit dem neuen Forschungsdatenzentrum Gesundheit (FDZ Gesundheit) werden die Abrechnungsdaten der gesetzlichen Krankenversicherungen erstmals zentral für datengestützte Gesundheitsforschung nutzbar gemacht.
Real-World Evidence

Real-World Evidence

Real-World Evidence (RWE) is clinical evidence regarding the use, potential benefits, and/or risks of a medical therapy. It is derived from the analysis of real-world data (RWD).
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Recent publications

→ Denis Poddubnyy, Joachim Sieper, Servet Akar, Santiago Muñoz-Fernández, Hildrun Haibel, Mikhail Protopopov, Elisabeth Altmaier, Fabiana Ganz, Robert D Inman
Achieving inactive disease state in men and women with axial spondyloarthritis: results from a multi-country prospective observational study 
https://doi.org/10.1093/rheumatology/keaf447

→ Kai‑Michael Beeh, Karl Scheithe, Heike Schmutzler, Saskia Krüger
Clinically Important Improvements and Disease Stability with Fluticasone Furoate/Umeclidinium/Vilanterol Once‑Daily Single‑Inhaler Triple Therapy in the ELLITHE Trial: A Post Hoc Responder Analysis
https://doi.org/10.1007/s41030-025-00306-1

→ Wolfgang A Schmidt, Marco Alibone, Paul Ludwig, Dominik Obermüller, Franziska Karl, Stephanie Terner, Nils Venhoff  
Frequency, diagnosis, and management of polymyalgia rheumatica in Germany—database analysis of medical insurance data
https://doi.org/10.1093/rheumatology/keaf367

→ Stephan Weidinger, Tobias Schadeck, Felix Jacobs, Ansgar Weyergraf, Dariusch Mortazawi, Tobias Hagemann, Fatima Abousamra, Thomas Mosch, Bjoern Fritz & Felix Lauffer 
Early Achievement of High Treatment Targets in Moderate-to-Severe Atopic Dermatitis with Upadacitinib: Real-World Evidence from the Observational UP-TAINED Study
https://doi.org/10.1007/s13555-025-01373-7

→ Südmeyer M, Pedrosa DJ, Siebecker F, Arlt C, Kopra JJ, Jost WH  
Utilization of MANAGE-PD Tool in a Real-World Setting in Germany: A Cross-Sectional Study Brain Sci. 2024 Jun 24;14(7):630. doi: 10.3390/brainsci14070630
PMID: 39061371
https://doi.org/10.3390/brainsci14070630

→ Daniel Weiss, Georg Ebersbach, Jens Carsten Möller, Johannes Schwarz, Carolin Arlt, Björn Fritz, Sven-Christian Sensken, Karla Eggert

Do we start too late? Insights from the real-world non-interventional BALANCE study on the present use of levodopa/carbidopa intestinal gel in advanced Parkinson's disease in Germany and Switzerland
DOI: 10.1016/j.parkreldis.2022.08.018

→ Matthias Augustin, Dominik Beier, Jennifer Branner, Dennis Häckl, Regina Hampel, Thomas Kramps, Hjalmar Kurzen, Hannah Lintener, Nima Melzer, Malina Müller, Petra Staubach, Uwe Schwichtenberg, Christian Termeer, Alexander Zink, Petra Nathan, Marcus Maurer

The socio-economic burden of H1-antihistamine-refractory chronic spontaneous urticaria in Germany,
First published: 11 May 2024 https://doi.org/10.1111/jdv.20071

→ Poddubnyy, Denis; Sieper, Joachim; Akar, Servet; Muñoz-Fernández, Santiago; Haibel, Hildrun; Diekhoff, Torsten; Protopopov, Mikhail; Altmaier, Elisabeth; Ganz, Fabiana; Inman, Robert D

Radiographic Progression in Sacroiliac Joints in Patients With Axial Spondyloarthritis: Results From a Five-Year International Observational Study.
ACR Open Rheumatol 6(2):p 103–10, Feb 2024. doi: 10.1002/acr2.11642
http://doi.org/10.1002/acr2.11642

→ Kai-Michael Beeh, Karl Scheithe, Heike Schmutzler & Saskia Krüger

Real-World Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily
Single-Inhaler Triple Therapy for Symptomatic COPD: The ELLITHE Non-Interventional Trial,
International Journal of Chronic Obstructive Pulmonary Disease, , 205-216, DOI: 10.2147/
COPD.S427770
https://doi.org/10.2147/COPD.S427770
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Current events

There are no upcoming events.
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White Paper
EU Clinical Trials
Regulation

GKM is a reliable partner of pharmaceutical, biotech and medical device companies for planning and conducting clinical trials phase II-IV as well as for non-interventional studies.

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valid through September 2026

GKM has earned a Bronze Medal, a recognition awarded to the Top 35% of companies assessed by EcoVadis in the 12 months prior to the medal issue date. It reflects the quality of the company’s sustainability management system and demonstrates a commitment to promoting transparency throughout the value chain.
Learn more about EcoVadis Medals & Badges.

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