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  • Clinical Operations

The MDR has tightened the requirements for clinical data, particularly for class III devices, implantable medical devices and those whose conformity is based on equivalence data. If the available clinical data is insufficient, the medical device manufacturer must collect it through clinical investigations or PMCF measures. Planning, executing, and approving such studies can be time-consuming and require significant resources, but they also provide an opportunity to gather valuable clinical data and meet regulatory requirements efficiently.

We offer support in closing data gaps, developing effective market entry strategies, and successfully conducting feasibility analyses and study launches. Our customisable clinical data management and an efficiently designed process ensure reliable data collection that optimally supports your medical devices' smooth market entry. Our comprehensive clinical project management supports you in all phases of the clinical investigation – from the initial phase through the submission and execution of the study to the management and analysis of the data.

Our Expertise

We manage all aspects of clinical investigations from clinical strategy consulting to the publication of the study results. Our services can also be ordered as a complete package or individually when support is only needed for specific activities of a clinical investigation.

Strategy and Consulting for Clinical Investigation

Tailored strategies designed to meet your specific requirements

Clinical Project Management

Guidance through clinical studies from the pilot phase to the post-market phase

Document Management

Comprehensive document handling to keep your clinical files complete, accurate, and compliant with regulations

Clinical Data Management

Collection, processing, validation and storage of clinical investigation data

Statistics

Support ranges from sample size calculation and custom study designs to creating and validating analytical tools

Site Management

Qualification and selection of appropriate sites, comprehensive monitoring, contract negotiation and budget oversight

Why choose us

Expertise

Benefit from our extensive experience and knowledge in clinical research and market access strategies.

Efficiency and cost savings

We help you save time and costs through strategic planning and optimisation.

Comprehensive support

We provide comprehensive support throughout all phases of the clinical investigation process, from feasibility to publication.

Customer Feedback

«ISS AG successfully acts as a CRO for the demanding clinical studies of our class IIb products, prepares clinical evaluations and supports the transition to MDR. Thanks to this "one-stop shop", we have exploited many synergies and are very satisfied with the collaboration.»

«ISS AG supported us in our first major international (four countries), multicentre (14 sites) study of our medical device "abioSCOPE". Through this project, ISS AG has played a significant role in helping us achieve one of our most important development milestones, the CE marking of our sepsis rapid test on our point-of-care IVD platform.»

«Dear ISS Team: We would like to thank you once again for your help and support during the clinical study and for your very helpful advice regarding the classification of the substance-based medical device (spray).»

Contact

Take advantage of our expertise and work with us to make your clinical study successful. Contact us today to find out more about how we can help you.

Bernhard Bichsel

Bernhard Bichsel

Co-CEO
Julie Tantau

Julie Tantau

Head of Clinical Operations

Contact us

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