Quality Assurance Services
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AUDITS
Our Quality Assurance and Training Department provides our clients with QA services as part of a full-service or a standalone project. We can assist companies that do not have the resources to perform the following tasks:
AUDITS
- Clinical investigational site audits - we provide routine, directed, specialized and pre-inspection audits to help sites to prepare for corporative audits and regulatory inspections
- System audits - we can support companies that would like to increase quality and need guidance
- Co-monitoring visits - we can accompany Site Monitors on monitoring visits and provide extensive reports on Monitor performance. We can also provide individual training as a co-monitoring follow-up
- Trial Master File audits - we can review TMF in office
- Post audit support - we can implement Corrective and Preventive Action plans and process improvement implementations
TRAININGS
We organize training sessions on GCP, FDA & ICH regulations, preparation to audit and to inspections:
We organize training sessions on GCP, FDA & ICH regulations, preparation to audit and to inspections:
- Staff training
- Investigator training (can be organized in any country of CEE)
STANDARD OPERATING PROCEDURES
- SOP review: we can review Client's SOPs, update them, adapt them to Client specifics needs and format them according to specific requirements
- SOP writing: we can write SOPs in the areas related to clinical operations
Other quality related activities which can be tailored on our customer’s specific needs.