Sponsor Oversight is a legal requirement according to GCP.
Here Gunnar Danielsson, former GCP inspector, talkes about Sponsor oversight and its requirements and common inspection findings
LINK Medical has worked with Gunnar Danielsson for 10+ years and he has been a true asset to the company with his knowledge and experience from inspections all over the world.
Medical Director Rikard Reneland here has a conversation with Gunnar Danielsson about inspection findings and the requirements in terms of sponsor oversight.
When a clinical study is outsourced to a CRO, the sponsor still has the responsibility for the study.