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Quality

EP-SOGO has a comprehensive quality control function to manage incidents or accidents. EP-SOGO’s Quality Control shares the information about incidents and accidents cross-organizationally to enable us take immediate corrective actions and preventive actions.

Quality Control System of EP-SOGO

EP-SOGO promotes cross-organizational quality control to provide high-quality support operations for clinical sites.

EP綜合における品質管理体制

Role of Quality Control

The Quality Control Department promotes and manages company-level quality control of clinical trial supports, including but not limited to the services provided by clinical research coordinators. The Quality Control staff have extensive knowledge and experience on clinical trials, including related laws and regulations (GCP, etc.), and develop effective strategies for improvement and consistency of service quality, and thorough compliance to regulations.

Role of Person in Charge of Quality Control

At each branch, EP-SOGO deploys persons (belonging to the Quality Control Department) in charge of quality control and familiar with the clinical trial services to prevent deviation and improve the quality of clinical trial data. The persons in charge of quality control visit clinical sites and check their operations from a third person’s point of view to evaluate if the site support services are conducted in accordance with specified procedures.

品質管理担当者

Risk Management

Subcommittee for Incidents and Accidents

Centrally controls incident or accident cases including near-misses, shares the information in the company, works out what the critical cause is, considering not only human and material factors but also background management factors in the expert committee, and implements fundamental countermeasures based on it to prevent recurrence.

Compliance

EP-SOGO focuses on compliance and endeavors to ensure reliability of clinical trial data.

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