Clinical Investigations and Studies
Ensure the quality of your clinical investigation and its results with our support
Regulatory safety
No more sweating when audits or reviews are due: We help you to prepare your data collection in line with requirements and document it in accordance with regulations.
Cost savings
Through optimal planning and preparation, we manage to minimize the expenses for studies and inspections, case number planning, and submission so that the costs for data collection do not deprive you of your approval.
Top expertise for various countries and product types
Our team covers a wide range of product types and country-specific requirements, whether substance-based medical devices or active implants. That way, you can be sure that authorities will accept your applications and results.
Sometimes a clinical investigation cannot be avoided
Manufacturers must systematically collect and evaluate clinical data to fully demonstrate a medical device's safety and performance.
Unfortunately, there is not always enough clinical data available, which means that manufacturers have to collect it themselves as part of a usually costly investigation.
We help you to successfully master clinical data collection
Study design
Our team of experts will help you determine an adequate study design for your clinical investigation and coordinate it with the relevant authorities.
Statistical case number planning
We help you carry out solid case number planning and calculations and show you the effects of various statistical variables. We will provide you with a case number report that clearly shows all the variables.
Selection of suitable CROs
We have an extensive global network of partners and can help you select the proper Contract Research Organization (CRO).
Submission to authorities
If required, we can help you prepare the study documentation so that all your documents are regulatory compliant.
Further support for the clinical evaluation of your medical device
Clinical Strategy
We help you develop an optimal clinical strategy, so you know what to expect during the clinical evaluation.
Clinical Studies and Investigations
With our support, you can ensure the quality of your clinical study or investigation and its results.
Guided Clinical Evaluator
Discover the Guided Clinical Evaluator - your solution for the autonomous creation of clinical evaluations.
Post-Market Surveillance and Post-Market Clinical Follow-up
Our support does not end with approval. We are also at your side in the areas of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF).
Post-Market Radar
Automate your Post-Market Surveillance: We take over the continuous monitoring of the relevant notifications for your devices.
Seminars, and Workshops
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops allow you to talk to experts at eye level.
Back To Top
Privacy settings
We use cookies on our website. Some of them are essential, while others help us improve this website and your experience.