The terms “clinical study”, “clinical trial” and “clinical investigation” are often used synonymously, without differentiating explicitly which type of “systematic investigation in human subjects” is concerned. However, different regulatory requirements are to be fulfilled, depending, for instance, on the fact whether

  • the medical device is already legally marketed, or
  • additional invasive and burdensome examinations are necessary within the scope of the “systematic investigation in human subjects”, or
  • the purpose of the “systematic investigation in human subjects” is to assess the safety or performance of a medical device.

It is crucial that these are identified at an early stage during the preparation, as they have a considerable impact on the resources, project cost and time line.
Which aspects you need to consider, you will learn in a dialogue with our experts. From the preparation of your clinical study/investigation through the conduct up to the data evaluation we offer individual services or the “all-round carefree package” to our customers. Thereby, our team undertakes tasks, including but not limited to the following areas:

Project Management
  • Definition and coordination of work packages
  • Communication with all involved stake holders
Legal and regulatory framework
  • Insurances
  • Approval process competent authority and ethics committee
  • Implementation of standard operating procedures and creation of templates
Preparation of the clinical study/investigation
  • Development of study design, including statistical considerations
  • Development of (electronic) Case Report Forms
  • Creation and Review of required documents (e.g. clinical investigation plan, investigator`s brochure, Patient information and patient consent)
  • Selection of sites
Conduct and close out of the clinical study/investigation
  • Continuous data management
  • Continuous monitoring
  • Statistical data evaluation
  • Final report

Our quality management system is certified according to ISO 9001. Our procedures warrant that, when conducting a clinical study/investigation, the requirements of the ISO 14155 as well as the Medical Devices Act (German: MPG) and the MPKPV are fulfilled.
You would like to learn more about clinical studies/investigations or you seek specific support? It would be our pleasure to schedule a non-binding phone call with you.
Take the opportunity to visit one of our seminars, for instance “Clinical Evaluation and Clinical Investigation”, or to customize an in-house training to your specific needs.