Clinical Investigation

A clinical investigation means any systematic investigation involving one or more human subjects undertaken to assess the safety or performance of a medical device and to generate new clinical data.

Clinical investigations include different types of studies. A well-known example is the clinical investigation, which is necessary before a medical device can be placed on the market if there is insufficient clinical data for approval or if a new purpose must be defined. However, clinical studies can also be planned after the market launch (PMCF studies), for example to gain important insights into the long-term effects of the treatment or to discover new risks. Depending on the type of study, there are different regulatory requirements defined by the MDA (Medical Devices Act), MPKPV, ISO 14155 or Regulation (EU) 2017/745.

Do you need support in generating clinical data? Do you know which aspects you need to consider in your clinical investigation or other type of study? Contact us and talk with our experts about your clinical data and a possible curriculum. Have you already performed a clinical investigation? As part of medical writing, we summarize the results in a final report or a scientific publication. We also offer a seminar that covers all relevant points extensively.

Clinical study services include:

  • Project management
    • Defining and coordinating work packages
    • Communicating with involved stakeholders
  • Legal and regulatory framework
    • Insurances
    • Approval process via DIMDI/BfArM/PEI and ethics committee
    • Submission and communication with the relevant authorities and ethics committee
    • Implementing work instructions and creating form sheets
  • Preparing a clinical investigation/study
    • Developing the study design, including consideration of biometric aspects
    • Developing (electronic) case report forms
    • Creating and reviewing required documents (e.g. clinical investigation plan, investigator brochure, patient information and consent)
    • Selecting test centers
  • Conducting and completing the clinical investigations/study
    • Continuous data management
    • Continuous monitoring
    • Statistical data evaluation
    • Final report
  • Creating a scientific publication manuscript (after CONSORT, STROBE etc.)
  • Training with training certificate

For more details on clinical investigation or for a non-binding offer contact us.