Let's introduce myself
My name is Sanne Derks and I founded Common Sense Clinical in 2019. In the past 13 years I have worked from various perspectives with a lot of different clinical trial procedures and clinical quality systems.
Unfortunately, the general consensus is that standard operating procedures are boring, useless and terrible to read. What struck me is that the procedures seem to be written for compliance purposes only, while one can get so much more advantages out of their quality system. This inspired me to create a clinical QMS that is readable, practical and flexible, while still being compliant.
Another reason for founding Common Sense Clinical is that I have seen many companies struggling with setting up a straightforward post-marketing study, but get stuck on the QMS part. Device manufacturers have a ISO13485 compliant QMS, but never got the clinical procedures developed for varying reasons (e.g. outsourced pre-market studies). When setting up studies for Post-Marketing Surveillance (PMS) or Post-Marketing Clinical Follow-up (PMCF), under MDR the only option seems to be outsourcing (again) to a CRO, with all financial consequences. With the Common Sense Clinical QMS PMCF studies can be kept inhouse and only the required expertise needs to be resourced, keeping budget under control.
