{"id":5443,"date":"2015-04-10T09:16:28","date_gmt":"2015-04-10T09:16:28","guid":{"rendered":"https:\/\/www.gkm-therapieforschung.de\/home\/"},"modified":"2026-03-09T08:50:29","modified_gmt":"2026-03-09T07:50:29","slug":"home","status":"publish","type":"page","link":"https:\/\/www.gkm-therapieforschung.de\/en\/","title":{"rendered":"Home"},"content":{"rendered":"

GKM Gesellschaft f\u00fcr Therapieforschung mb<\/span>H<\/span><\/p><\/h1><\/div>

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Your full-service CRO in Germany for clinical research with drugs and medical devices<\/span><\/p>\n

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Clinical Research Services for international and national clinical trials and non-interventional studies<\/span><\/p><\/h2><\/div>

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Monitoring<\/span>MuenicusGeneralis<\/a><\/span><\/span>2025-04-08T12:52:01+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tMonitoring<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Monitoring<\/a><\/h4><\/div><\/div>
Regulatory<\/span>MuenicusGeneralis<\/a><\/span><\/span>2025-04-08T12:52:35+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tRegulatory<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Regulatory<\/a><\/h4><\/div><\/div>
Project management<\/span>MuenicusGeneralis<\/a><\/span><\/span>2025-04-08T12:53:03+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tProject management<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Project management<\/a><\/h4><\/div><\/div>
Medical Advising and Medical Writing<\/span>MuenicusGeneralis<\/a><\/span><\/span>2025-04-08T12:53:37+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tMedical Advising and Medical Writing<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Medical Advising and Medical Writing<\/a><\/h4><\/div><\/div>
Concept Development<\/span>hyad<\/a><\/span><\/span>2025-04-08T12:54:07+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tConcept Development<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Concept Development<\/a><\/h4><\/div><\/div>
Quality Assurance<\/span>hyad<\/a><\/span><\/span>2025-04-08T12:54:40+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tQuality Assurance<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Quality Assurance<\/a><\/h4><\/div><\/div>
Data Management<\/span>hyad<\/a><\/span><\/span>2025-04-08T12:55:28+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tData Management<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Data Management<\/a><\/h4><\/div><\/div>
Biostatistics<\/span>hyad<\/a><\/span><\/span>2025-04-08T12:55:59+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tBiostatistics<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Biostatistics<\/a><\/h4><\/div><\/div>
Vigilance<\/span>hyad<\/a><\/span><\/span>2025-04-08T12:57:58+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tVigilance<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Vigilance<\/a><\/h4><\/div><\/div>
Medical Devices<\/span>hyad<\/a><\/span><\/span>2025-04-08T13:01:31+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tMedical Devices<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Medical Devices<\/a><\/h4><\/div><\/div>
Benefit Assessment according to \u00a7 35 a SGB V<\/span>hyad<\/a><\/span><\/span>2025-04-10T14:31:09+02:00<\/span>
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\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\tBenefit Assessment according to \u00a7 35 a SGB V<\/a>\n\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\t\t<\/a>\n\t<\/div>\n<\/div>\n<\/div>\n

Benefit Assessment according to \u00a7 35 a SGB V<\/a><\/h4><\/div><\/div><\/div>
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CLINICAL RESEARCH ORGANIZATION (CRO)<\/h2><\/a><\/div>
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As a\u00a0Contract Research Organization<\/strong>\u00a0since 1981, GKM stands for flexibility, continuity and quality while planning, managing and realizing your clinical trial or non-interventional study. >> More about us<\/a>
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MEDICAL ADVANCEMENT THROUGH EFFECTIVE RESEARCH<\/h2><\/a><\/div>
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36 years of experience in\u00a0clinical research<\/strong>\u00a0with clinical trials and non-interventional studies involving over 800 national and international projects with drugs and medical devices. >> More about our projects<\/a> <\/div><\/div><\/div>

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For\u00a0smart decision makers\u00a0<\/strong>in the pharma and medical device industry Receive up-to-date information and insights on truly relevant topics in clinical research!<\/p>\n

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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)!<\/span><\/h2>\n<\/div>
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Latest Articles, Publications & Events<\/h2><\/h2><\/div>
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Newest articles<\/h2><\/div>
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Please note that for our specialist articles you will be redirected to\u00a0knowledge base for clinical research \u201cCliNFo.EU\u201d.<\/a> \n\t\t\n\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"IMPs\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t

\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tIMPs vs. AxMPs: What\u2019s the Difference and Why Does It Matter?\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tIn 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.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDas Forschungsdaten­zentrum Gesundheit \u2013 eine neue Datengrundlage f\u00fcrs AMNOG Verfahren?\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tMit dem neuen Forschungsdatenzentrum Gesundheit (FDZ Gesundheit) werden die Abrechnungsdaten der gesetzlichen Krankenversicherungen erstmals zentral f\u00fcr datengest\u00fctzte Gesundheitsforschung nutzbar gemacht.\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Real-World\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t

\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tReal-World Evidence\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h2>\n\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tReal-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). \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t<\/div>\n\n\t\t
FIND OUT MORE!<\/span><\/a><\/div> <\/div><\/div><\/div>

Recent publications<\/h2><\/div>
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\u2192 Denis Poddubnyy, Joachim Sieper, Servet Akar, Santiago Mu\u00f1oz-Fern\u00e1ndez, Hildrun Haibel, Mikhail Protopopov, Elisabeth Altmaier, Fabiana Ganz, Robert D Inman<\/span>
\nAchieving inactive disease state in men and women with axial spondyloarthritis: results from a multi-country prospective observational study\u00a0<\/span>
\nhttps:\/\/doi.org\/10.1093\/rheumatology\/keaf447<\/a><\/p>\n

\u2192 Kai\u2011Michael\u00a0Beeh, Karl\u00a0Scheithe, Heike\u00a0Schmutzler, Saskia\u00a0Kr\u00fcger<\/span>
\nClinically Important Improvements and Disease Stability with Fluticasone Furoate\/Umeclidinium\/Vilanterol Once\u2011Daily Single\u2011Inhaler Triple Therapy in the ELLITHE Trial: A Post Hoc Responder Analysis<\/span>
\nhttps:\/\/doi.org\/10.1007\/s41030-025-00306-1<\/a><\/p>\n

\u2192 Wolfgang A Schmidt, Marco Alibone, Paul Ludwig, Dominik Oberm\u00fcller, Franziska Karl, Stephanie Terner, Nils Venhoff\u00a0\u00a0<\/span>
\nFrequency, diagnosis, and management of polymyalgia rheumatica in Germany\u2014database analysis of medical insurance data<\/span>
\nhttps:\/\/doi.org\/10.1093\/rheumatology\/keaf367<\/a><\/p>\n

\u2192 Stephan Weidinger, Tobias Schadeck, Felix Jacobs, Ansgar Weyergraf, Dariusch Mortazawi, Tobias Hagemann, Fatima Abousamra, Thomas Mosch, Bjoern Fritz & Felix Lauffer\u00a0<\/span>
\nEarly Achievement of High Treatment Targets in Moderate-to-Severe Atopic Dermatitis with Upadacitinib: Real-World Evidence from the Observational UP-TAINED Study
\n<\/span>https:\/\/doi.org\/10.1007\/s13555-025-01373-7<\/a><\/span><\/p>\n

\u2192 S\u00fcdmeyer M, Pedrosa DJ, Siebecker F, Arlt C, Kopra JJ, Jost WH \u00a0<\/span>
\nUtilization 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
\nPMID: 39061371
\nhttps:\/\/doi.org\/10.3390\/brainsci14070630<\/a><\/p>\n

→ Daniel Weiss, Georg Ebersbach, Jens Carsten M\u00f6ller, Johannes Schwarz, Carolin Arlt, Bj\u00f6rn Fritz, Sven-Christian Sensken, Karla Eggert<\/p>

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
\r\nDOI:\u00a0<\/span>10.1016\/j.parkreldis.2022.08.018<\/a><\/span><\/p><\/span>

→ Matthias Augustin, Dominik Beier, Jennifer Branner, Dennis H\u00e4ckl, Regina Hampel, Thomas Kramps, Hjalmar Kurzen, Hannah Lintener, Nima Melzer, Malina M\u00fcller, Petra Staubach, Uwe Schwichtenberg, Christian Termeer, Alexander Zink, Petra Nathan, Marcus Maurer<\/p>

The socio-economic burden of H1-antihistamine-refractory chronic spontaneous urticaria in Germany,
\r\nFirst published: 11 May 2024 https:\/\/doi.org\/10.1111\/jdv.20071<\/a><\/p><\/span>

→ Poddubnyy, Denis; Sieper, Joachim; Akar, Servet; Mu\u00f1oz-Fern\u00e1ndez, Santiago; Haibel, Hildrun; Diekhoff, Torsten; Protopopov, Mikhail; Altmaier, Elisabeth; Ganz, Fabiana; Inman, Robert D<\/p>

Radiographic Progression in Sacroiliac Joints in Patients With Axial Spondyloarthritis: Results From a Five-Year International Observational Study.
\r\nACR Open Rheumatol 6(2):p 103\u201310, Feb 2024. doi: 10.1002\/acr2.11642
\r\nhttp:\/\/doi.org\/10.1002\/acr2.11642<\/a><\/p><\/span>

→ Kai-Michael Beeh, Karl Scheithe, Heike Schmutzler & Saskia Kr\u00fcger<\/p>

Real-World Effectiveness of Fluticasone Furoate\/Umeclidinium\/Vilanterol Once-Daily
\r\nSingle-Inhaler Triple Therapy for Symptomatic COPD: The ELLITHE Non-Interventional Trial,
\r\nInternational Journal of Chronic Obstructive Pulmonary Disease, , 205-216, DOI: 10.2147\/
\r\nCOPD.S427770
\r\nhttps:\/\/doi.org\/10.2147\/COPD.S427770<\/a><\/p><\/span>

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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.<\/p>\n

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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\u2019s sustainability management system and demonstrates a commitment to promoting transparency throughout the value chain.
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