What we do
Common Sense Clinical is founded around the post-marketing, ISO14155 compliant clinical QMS, which is license based and plug-and-play. The QMS is highly flexible, designed to meet the needs of every study. With a license, full use of the QMS is obtained, which contains 18 procedures and over 80 forms. With the QMS, the study can be conducted from the planning to closure phase. When our clients are working with a license, they don’t need to worry about revising procedures and keeping the system up-to-date and compliant, this is fully managed by us. This option is ideal for smaller companies and investigators setting up an Investigator Initiated Study (IIS).
Another possibility is to purchase (parts of) the full QMS, which might be the right choice in some cases. However, with this option the responsibility for revision and maintenance of the procedures fully lies with the client.
Pre-market studies
For pre-market studies, we offer customized solutions for medical device companies looking to set-up or expand their clinical quality management system to ensure high quality data and maximum subject protection in a fully ISO14155:2020 complaint manner.
Consulting
We can support your study with every step of the way, from protocol writing to data management. We only work with highly experienced contractors, ensuring high quality services.
Whatever we do, we always start with taking time to get to know you and your company or institution to ensure you get the solution that will fit best.