Quality is, and has always been, an essential element of how we work. We do it ethically, with a strong regulatory foundation, and always with an eye to human subject protection above all else.
Our Quality Assurance Department assures compliance with quality standards required by local, national and international laws, as well as with the ICH GCP and regulatory guidelines. Routine activities cover regular investigational site auditing, and internal system auditing, together with organization and supervision of training implemented internally.
We have a comprehensive library of Standard Operating Procedures (SOPs) and Guidelines, which guarantees that client requirements are met and that our employees conform to regulations. Additionally ensuring that all company activities are controlled and documented and that we are able to operate also with our client's SOPs when requested.
SOPs and Guidelines are reviewed and updated regularly to ensure that they accurately reflect current practice as well as GCP and regulatory requirements.
- Trial master file audit
- Investigator site audit
All audits are performed to review adherence and compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, regulatory requirements, the trial protocol, client instructions and contractual obligations.