Quality Assurance
Our Quality Assurance Unit places much emphasis on supporting project teams in their effort to conduct high quality clinical research work. For us, constructive co-operation is just as important as control. The key elements of this approach are:
International SOPs in compliance with ICH-GCP requirements, which, in spite of detail and structure, are still flexible enough to facilitate the conducting of a study
- Continued training and qualification of team members in GCP issues and SOPs
- Internal and external audits
Audits in the Baltic States, Russia and the Ukraine are conducted by native speakers. In order to assure that auditors and operational project team members »speak the same language«, profound experience in clinical research is mandatory before becoming a Scope International auditor.
The services we offer
- Audit of clinical trials; including the audit of study documents, investigational sites, database, final report
- Audit of systems and procedures
- Advice on GCP and regulatory requirements
- Support in the preparation and review of SOPs
- Training in ICH-GCP requirements
- Assistance in the implementation of regulatory and ICH-GCP requirements