Severimed is a well organized and flexible Clinical Research Organization
and holder of various patents operating mainly in the following countries: Germany, The Netherlands, Belgium, South Africa and the USA

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.

  • SERVICES

    Project management for phase II-IV studies
    Biostatistics
    Regulatory affairs
    Temporary secondment of our research personal
    Packing and labelling of study materials
     

  • MONITORING

    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.

  • INVESTIGATORS

    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

  • LABORATORIES

    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.

  • DATA MANAGEMENT

    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.

  • MEDICAL WRITING

    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

  • RESEARCH STAFF

    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