Clinical Data Management

Quality assurance

We have developed a quality management manual, which defines the SOPs of our lab and has been developed and validated in official audits from our sponsors.

This SOPs reflect the workflows which appear in our daily lab routine. Working according to this SOPs is an important enabler for GCP-compliance and high quality results.

Reporting

We provide periodic reports to our customers to inform about the current analysis status

Our reports can be customized according to the wishes of our customers and to fulfill the specific requirements of each clinical trial

The following list is only a subset of informations which can be included in our reports:
  • Image data transfer status
  • Image quality
  • Reading status
  • Other problems (technical issues, common mistakes of sonographers, ...)

Image archiving

All images submitted to the Core Lab are duplicated and archived. This serves as the source documentation for our analysis. All studies are copied onto a secure server that has nightly backup. All images and measurements used for analysis will be stored in duplicate; One copy is saved on the Core Lab server which is backed up nightly and the other copy is burned onto an external hard drive which is stored in a fire proof file cabinet.