Project management for phase II-IV studies
Biostatistics
Regulatory affairs
Temporary secondment of our research personal
Packing and labelling of study materials
We have specialized expertise in infectious diseases (e.g. urinary tract infections, respiratory tract infections), metabolic and nutritional disorders, mental disorders, and cellular aging processes.
We use a network of trained clinical investigators and basic scientists and work with large laboratories with nationwide courier services.
By using remote data entry we manage large trials meeting the quality standards imposed by ICH, FDA and the EEC Good Clinical Practice Guidelines.
Project management for phase II-IV studies
Biostatistics
Regulatory affairs
Temporary secondment of our research personal
Packing and labelling of study materials
Our CRAs and CRMs have at least 3 years’ experience in clinical research. They are geographically well located to visit study sites as often as needed. They are fluent in German, Dutch and English. They include MDs, PhDs, or well-trained laboratory technicians who can, for example, assist with blood sampling. We can also work with other CRAs on a project basis.
We have a network of general practitioners, internists, cardiologists, nephrologists, urologists, pulmonary specialists, geriatricians, microbiologists, and others at our disposal. They are experienced investigators familiar with GCP, ICH, and related guidelines. Their experience includes antibiotic trials, metabolic and nutritional disorders, mental disorders, and disorders of aging. Some of our work is patented
The benefits of using centralized laboratory procedures are indisputable. Therefore we have access to a network of qualified laboratories with well-organized courier services in each of the countries we operate in. For example, samples can be sent from any site in Germany, Belgium and The Netherlands to the central laboratory in less than 24 hours, and results are returned quickly. Specialized testing for parameters such as methylmalonic acid, homocysteine, cystathionine, and 2-methyl-citric acid is also available.
We use automated centralized data processing measures to obtain timely and efficient results, reduce errors, and minimize protocol violations. We will synchronize our procedures and our data formats to make them compatible with those of our clients.
Study protocol
Case report form design
Patient information
Patient informed consent
Medical data review
Medical coding
Adverse event reporting
Case narratives
Safety reports
Clinical study report
Our company was founded in 1990, the research staff consists of people with an average of 6 years or more experience in clinical research: They have worked on more than 30 different projects, some of these are listed here and results are published in top international medical journals