Global Quality related services
- Quality oversight: quality visits, mentoring/supervisory visits, assessments visits – focused on research site, monitoring quality, performance. These activities, implemented from the very beginning of the study, allow early detection of systemic issues and eliminate potential losses by implementing corrective and preventive actions
- Pre-inspection evaluation: his service is designed to support client’s preparation for regulatory inspection. It is focused on trial documentation and key processes review, enabling to identify gaps at the study level. Based on gap analysis and risk assessment Clinmark consultants provide recommendations and, if necessary, support for Corrective and Preventive Action plan development and implementation
- Audits: GCP research site audits, GCP TMF audits, GMP and GDP audits and consulting, GLP audits in laboratories, GVP audits, Mock inspections, Vendor Qualifications, CAPA management
- Adaptive risk-based audit program: high level service providing Clients with clear view and quality information on Sponsors clinical program or single project in terms of its quality status, real and potential risks together with risk identification, analysis including – RCA (Root Cause Analysis) and statistical methods, prioritization, assessment, and mitigation strategy with relation to risk impact on the whole program. Step by step adaptive approach enables to adjust the scope of service and its budget to real need of the program
We work based on internal quality management system, which consists of the following elements:
- Standard Operating Procedures (SOPs)
- Staff Trainings
- In line with regulations
The quality management system is based on our international audit and advisory experience and continuously improved.