Clinical Investigation

The term clinical study covers different types of studies and clinical investigations. A clinical investigation is a systematic review of one or more subjects to evaluate the safety and performance of a medical device and generate new clinical data. A clinical investigation prior to market entry of the medical device will become necessary if there is no sufficient clinical data for approval or if a new intended use is to be defined. There are different regulatory requirements defined by the MPG, the MPKPV, the ISO 14155 and also the Medical Devices Regulation 2017/745. Do you already know which aspects should be considered in your clinical investigation or other types of clinical studies? Please contact us and talk with our experts about your clinical data and possible clinical study planning. In addition, we offer a seminar on this topic, in which all relevant points are discussed extensively.

Our clinical study services include:

    • Project Management
      • Definition and coordination of work packages
      • Communication with involved stakeholders
    • Legal and regulatory framework
      • Insurance
      • Approval process via DIMDI / BfArM / PEI and Ethics Committee
      • Submission and communication to relevant authorities and the Ethics Committee
      • Implementation of procedural instructions and creation of forms
    • Preparation of clinical investigations / studies
      • Development of the study design, including consideration of biometric aspects
      • Development (electronic) Case Report Forms
      • Preparation and Review of Required Documents (e.g., clinical investigation plan, investigator brochure, patient information and consent)
      • Selection of study sites
    • Execution and completion of the clinical study / investigation
      • Continuous data management
      • Continuous monitoring
      • Statistical data evaluation
      • Final report

For further details regarding “Clinical Study” or for a quotation just contact us.