Services
Clinical Research Organization (CRO)
As a Clinical Research Organization (CRO), we exclusively support you in all clinical investigations with medical devices. We explain our service to you on the following pages. Let's start with the strategy first.
The pre-study phase
At the beginning of every project there is the creation of a strategy. We call this phase the “Pre-Study Phase”. In 3 steps we determine the right and cost-effective strategy for clinical data collection. We proceed as follows:Step 1:
Determine strategy
First, we work with you to determine the framework parameters for your project. Using checklists, we collect the necessary information in interviews, discussions and/or workshops and/or via documents provided.
Step 2:
Set up a strategy
We use the information gained to create a strategy tailored to you. We pursue the following goals:
- determine the steps necessary from an MDR and regulatory perspective
- establish a cost-effective way to ensure the appropriateness of the measures
Step 3:
Set strategy
We use the results from phase 2 to work with you to define a strategy for the necessary clinical trial. Together we will determine a route that will take you to the goal of your project.