Conducting clinical performance studies with IVDs
ISO 20916 & EU 2017/746

Good reasons for our cooperation

• In a collaboration, you benefit from our competent network, through which we can conduct studies worldwide.
• With a large number of performance studies already carried out, we can start new studies with a similar design very quickly.
• We offer you a one-stop shop for conducting performance studies. We offer all the necessary steps from planning, qualification of the study sites, collection of data, statistical evaluation and preparation of the complete study documentation as a complete package.
• By carefully selecting suitable study locations, we save you large sums of money on the project budget!

The clinical performance study on human test material according to ISO 20916 on good study practice is the basis for our joint project.

Do you have an IVD for the detection of SARS-CoV-2? Then we also use the MDCG 2021-21 guidance on the performance evaluation of SARS-CoV-2 in vitro diagnostic devices.

Project start

Starting with the first project enquiry, we use standardised processes until the project is completed. This not only ensures optimal communication, but also enables us to provide the most precise cost estimates. Before the start of each project, all cost items are disclosed in detail and discussed with you. This way you know exactly which fixed and variable costs to expect at the start of the project.

The following points show the usual process from the request to the start of a project.

• Receipt of a request
• Internal review: We discuss with our team and partners the possibilities for realising the requested project.
• Feedback to the client: Depending on how much information was already available for the enquiry, either further information is requested or we can confirm the feasibility and arrange a first meeting.
• First meeting: Together with you, we discuss your ideas for the project, relevant legal and regulatory requirements and thus create an overview of the best study design.
• Selection of potential study sites: Based on the discussed study design, we request cooperation from potential study sites.
• We discuss the study design in detail with the respective experts of the study sites in order to identify possible optimisation potential by involving all experts.
• If there is potential for optimising the study design, this will be discussed with you and taken into account for the calculation.
• Obtaining cost estimates from the study sites: Through close communication with potential study sites, we obtain accurate cost estimates.
• Selection of the most suitable study sites for further calculation: We select the most suitable sites based on factors such as expected throughput of subjects per study site, costs, expertise and others.
• Preparation and provision of the total cost estimate for the project: In order to provide you with an overview of the expected total costs of the project, we calculate all expected cost blocks for our services, performances of laboratories and other third parties (e.g. transport costs and customs).
• Second meeting: In a second meeting, we discuss the cost estimate and the further course of action with you, such as further adjustments or the start of the project.