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)!

Planer KS
     
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”.

Anwendungsbegleitende Datenerhebungen (AbD)

Anwendungsbegleitende Datenerhebungen (AbD)

Eine Anwendungsbegleitende Datenerhebung (AbD) ist eine nicht-randomisierte, vergleichende Evidenzgenerierung, die in der Regelversorgung durchgeführt wird. Der Gemeinsamen Bundesausschuss (G-BA) kann eine AbD anordnen, wenn die vorliegende Evidenz für ein Arzneimittel nicht zur Quantifizierung eines Zusatznutzens als ausreichend erachtet wird. Betroffen sind Arzneimittel für seltene Leiden (Orphan Drugs) sowie Arzneimittel mit speziellen Zulassungstypen (bedingte Marktzulassung oder Zulassung unter besonderen Umständen).
Electronic Signatures in Clinical Research

Electronic Signatures in Clinical Research

Digitalisation is profoundly reshaping professional landscapes, and clinical research—a field historically reliant on manually recorded paper documents—is no exception. Paper documents are rapidly being replaced by electronic alternatives, simplifying many aspects of our work. However, ensuring the validity and security of these digital records is paramount, especially when it comes to electronically signed documents in clinical research.
Pitfalls in the clinical trial submission process according to CTR

Pitfalls in the clinical trial submission process according to CTR

On January 31, 2022, the long-awaited Clinical Trials Information System (CTIS) portal for submissions under the Clinical Trial Regulation (EU) No. 536/2014 (CTR) went online. Since then, many of us have already gained first experiences with the portal – especially since all new clinical trials now have to be submitted via this portal and the deadline for the transition to CTR of ongoing clinical trials is clearly approaching.
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Recent publications

→ 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

→ Harbi, Othman Al; Owayed, Salem; Qari, Yousif; Mosli, Mahmoud; Anwar, Ali; Masri, Alaa; Gouda, Mohamed; Alfadhli, Ahmed

Correlation between physician- and patient-directed disease assessments in ulcerative colitis patients from Saudi Arabia and Kuwait: Data from ICONIC
Saudi Journal of Gastroenterology 29(6):p 381-387, Nov – Dec 2023  DOI: 10.4103/sjg.sjg_92_23
https://doi.org/DOI:%2010.4103/sjg.sjg_92_23

→ Dr. Ramona Schütz, Sabine Ditz

Lay Summaries of Clinical Trial Results
Pharm. Ind. 85, Nr. 9, 835–841 (2023):
https://tinyurl.com/ar8kk4vv or our blog article on this topic.

→ Seemüller F, Schennach R, Musil R, Obermeier M, Adli M, Bauer M, Brieger P, Laux G, Gaebel W, Falkai P, Riedel M, Möller HJ

A factor analytic comparison of three commonly used depression scales (HAMD, MADRS, BDI) in a large sample of depressed inpatients.
BMC Psychiatry. 2023 Jul 28;23(1):548. doi: 10.1186/s12888-023-05038-7. PMID: 37507656; PMCID: PMC10386606.
https://doi.org/10.1186/s12888-023-05038-7

→ Sylke Schneider-Burrus, Stefanie Kalus, Björn Fritz, Kerstin Wolk, Susana Gomis-Kleindienst, Robert Sabat

The impact of hidradenitis suppurativa on professional life.
Br J Dermatol. 2023 Jan 23;188(1):122-130. doi: 10.1093/bjd/ljac027. PMID: 36689513.
https://doi.org/10.1093/bjd/ljac027

→ A. Heratizadeh, M. Mempel, R. von Kiedrowski, S. Hagl, T. Mosch, B. Fritz, T. Werfel

Checklist identification of candidates for systemic therapy in adult patients with atopic dermatitis in Germany: A multicentre study (2023)
https://doi.org/10.1111/jdv.19465
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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.

Download White paper: