We have established a Quality Control Department as a specialized division responsible for our quality control. The Quality Control Department maintains and operates the Standard Operating Procedures for clinical trial site support operations, as well as manuals and operational tools for each type of work. In addition, it is responsible for specialized education (education related to the commissioning and implementation of site support services) and work to improve and homogenize the quality of site support services throughout the company through mutual collaboration with each branch and relevant departments.
01The Role of the Quality Control Department
Preparation and management of Standard Operating Procedures for clinical trial site support services
Creation of procedure manuals (templates) for medical institutions
Review and implementation of measures to ensure quality throughout the company
Handling of inquiries about questions (concerning GCP ministerial ordinances, etc.) in support of clinical trial sites
QC inspections (visits to sites to evaluate the appropriateness of CRC work procedures and clinical trial data)
Planning, drafting, and operation of professional education and training programs
02Process Management in Clinical Trials
We support and promote risk-based process management at medical institutions to ensure the quality of clinical trial data.
Our CRCs, Site Management Associates (clinical trial secretariat staff) and business development staff for sites support the establishment of a clinical trial implementation system and processes, in consultation with the investigator and site staff. In addition, quality control staff and a quality promotion manager visit the site and inspect from a third party's perspective to ensure that clinical trial operations are being conducted in accordance with the process.
Clinical Trial Process Management
STEP 01
Establishment of Clinical Trial Implementation System
Approach to medical institutions/ investigators
STEP 02
Building Processes
Risk extraction
Establishment of processes according to risk
Process clarification through documentation
STEP 03
Conducting clinical Trials
Clinical trial operations in accordance with the process
STEP 04
Confirmation of clinical trial operations
Checks by quality control/quality promotion manager (site visit)
STEP 05
Process Review
Process optimization
Root cause analysis of deviations that occurred
Establishment of recurrence prevention measures
Key Points for Quality Control/ Quality Promotion Manager to Inspect Operations
Start of Clinical Trial
Establishment of processes according to risk
Identification of source documents
Sharing of the process among the parties involved in the clinical trial
During Clinical Trial
Compliance with processes
Process validity
Source document creation following ALCOA
Storage of source documents
Follow-up
Status of improvement of concerned issues
Status of implementation of measures to prevent recurrence of deviations/accidents
Status of source documents in storage toward the end of the study
03Risk Management
The Quality Control Department centrally manages company-wide incident information through a reporting system. When an accident occurs, the department responds promptly and appropriately in cooperation with related parties and relevant departments. After an accident occurs, the Quality Control Department investigates and analyzes the incident/accident and the factors behind the case, and a specialized committee (Incident/Accident Subcommittee) investigates the cause of the case, examines measures to prevent recurrence, and promptly implements these measures in order to prevent recurrence.
We are committed to compliance and ensuring the reliability of clinical trial data.
