According to GCP and ISO 13485 guidelines
All processes within ProLifeSciences happen according the guidelines of GCP and ISO 13485.
ProLifeSciences sends clinical products to the clinical centers and makes sure clinical products are tracked until the product has been received by the clinical center specific person.
We supply full documentation to the CRO company, sponsor and center to complete the center specific device accountability log (DAL).
Our warehouse facilities have an electronic access management system.
The warehouse compartements are temperature/humidity logged and calibrated.
All processess within ProLifeSciences happen according to the guidelines of GCP and ISO 13485.