OUR SERVICE
GKM – CRO services, tailored to your needs
GKM’s more than 30 years of clinical research on behalf of prestigious sponsors has resulted in a track record of more than 700 successful national and international projects involving more than 1.5 million patients. The high quality of our CRO services has been endorsed by the positive outcome of numerous audits having been carried out at GKM by our sponsors and independent auditors. GKM sets high standards regarding the continuous updating of our scientific knowledge and technical skills. In order to meet these requirements, we assign major importance to GKM’s intensive training and educational programs and invest heavily in our technical systems, safety and security.
The CRO services we offer for national and international clinical trials or non-interventional studies are geared towards your specific needs. Quality, flexibility and sustainability are our main imperatives. We can either adopt your standard operating procedures or can offer you our own. We will always keep you informed about the progress of your project – just the way you need it. We aspire to gain your complete trust and to ease your workload in every possible way.
Monitoring
We provide clinical monitoring services that ensure your study complies with all regulatory requirements – and adheres to Good Clinical Practice at every stage. We interpret monitoring [...]
Regulatory
Submitting trials to the regulatory bodies such as ethics committees and authorities can be challenging. Despite ongoing harmonisation within the regulatory environment, you are faced with a [...]
Project management
GKM provides a truly professional project management and end-to-end project coordination with high quality and cost efficiency. Reap the benefits from our extensive practical expertise and process [...]
Medical Advising and Medical Writing
Do you require selected medical writing services, rather than an end-to-end package? No problem. The GKM team of medical advisors, statistical and medical writers offers you the [...]
Concept Development
You like to think outside the box? So do we! Do you have interesting ideas in your desk drawer, just waiting for you to have the time [...]
Quality Assurance
The GKM Quality Assurance department aims to create knowledge and foster a culture of excellence at all levels of our company. GKM Quality Assurance staff plays a [...]
Data Management
The path from raw data entries to valid and sound results is long and needs to be carefully maintained in order to minimise risks for your project. [...]
Biostatistics
Our biostatistics staff accompanies your project every step of the way, offering biostatistic advice on designing your study and selecting the appropriate endpoints. A team of two [...]
Medical Devices
Steadily increasing demands for high quality clinical data and a drastically changing regulatory framework represent major challenges for the medical devices industry in the European Union. You [...]
Benefit Assessment according to § 35 a SGB V
Involved from the beginning: Since the introduction of the Act on the Reform of the Market for Medicinal Products (AMNOG) in 2010, GKM has been offering services [...]