Quality Assurance and Standards at SAM GmbH

All processes in the course of clinical trials and non-interventional studies are carried out according to highest quality standards and according to the actual GCP/GMP and ICH guidelines.

Standard operation procedures (SOPs) are continuously re-checked and improved and form the foundation for all activities of staff of SAM GmbH.

Upon your request projects will be completely carried out according to your own SOPs

As well as the Remote Data Entry system ars®, SAM GmbH is regularly audited by external companies in the course of carrying out clinical trials.

Only the highest quality is accepted as a standard inside SAM GmbH.

Including the integrated Remote Data Entry System ars®, all quality assurance standards and processes are permanently simplified and improved.

The integrated Remote Data Entry System ars® was and is still developed according to ICH/GCP standards, to the requirements of the authorities (EMA, FDA) and with respect to ICH E2B standards for SAEs and DRAEs.