General advice on conducting clinical trials with medical devices
Competent Over 20 years of experience with medical device studies in ophthalmology.
- Solution-oriented You have a goal and we’ll show you how to get there.
- Versatile We know the variety of regulatory options for medical device studies
MDR, MDCG, ISO, GCP, EUDAMED, 21 CFR Part 11 - lost in the jungle of paragraphs?
We know them all and know what needs to be implemented and how. We will be happy to help you plan your studies in a targeted manner and show you different ways of achieving the desired study results and in what time frame.
The proper conduct of a clinical trial is one part of the challenge - the other part concerns data management with checking data consistency, the sensible and correct selection of statistical methods and the meaningful summary of the data in a report. And it would be a shame if the valuable clinical data were used solely to meet the requirements of the authorities - interesting publications and conference papers can certainly be compiled from them.
Contact us for further information!
Consulting for Post Market Clinical Follow-Up Strategies
Experienced Our focus is on post-market studies within and outside of the MDR.
- Knowledgeable Post-market studies and concepts are our specialty - we know our way around them.
- Creative Collecting data and using it for one purpose only? We show you ways to use the data once collected in a variety of ways.
The Post-Market Clinical Follow-Up (PMCF) is part of Post-Market Surveillance (PMS); both serve to demonstrate the performance and safety of medical devices after CE certification and launch. Does PMCF always have to be an expensive study or are there other ways to meet the requirements of the MDR? How do you set up a study so that the data is not only collected to meet the MDR requirements, but can also be used for presentations and publications? Which countries can be integrated and how well? What budget is required and what cost-effective options are available?
EDC / Data acquisition system targoDoc
User-friendly Simple and targeted color-code-controlled operation.
- Modular Use and pay for only the functions you need for your project.
- Powerhouse Comprehensive real-time statistics of all relevant parameters with graphical and tabular display of results at the touch of a button.
With targoDoc® we offer you a very user-friendly documentation system for studies (eCRF), surveys and other data collection. The focus of targoDoc® lies in the simple, clear operation, the modular structure and the unique evaluation tool, which analyzes the desired data at the touch of a button at any time in seconds and provides the finished graphics via copy & paste in your presentation.
Here you can find more information about targoDoc