Realizing High Quality and Speedy Monitoring
Our monitoring specialists, trained by our company’s special education for monitors and possessed of a high level of expertise knowledge, perform monitoring in compliance with GCP, SOPs, protocol and requests of the client. Various documents generated and collected in the study will be undergone strict quality checks by the quality control department and are filed and retained properly.
- Review of Medical Institutions and Investigators on GCP Compliance
- Explanation of Protocol to Investigators on GCP compliance
- Support Clinical Trial Plan Notification, Change Notification and Premature Termination/Completion Notification
- Request Clinical Trials to Medical Institutions and Process Site Contracts
- Response to IRB Review Results
- Contracts Finalization
- Arranging Startup Meetings
- Supply and Collection of Investigational Products
- Visit to Medical Institutions and Dissemination of Information
Improving Monitoring Quality through Meticulous and Appropriate Checks
To check whether a clinical trial is being conducted in compliance with related laws and regulations. Using quality control approaches as part of quality assurance. By performing timely, meticulous and appropriate checks from an objective viewpoint, we strive to maintain and improve the quality of monitoring.
Cultivate Monitors with Professional Skills
We have ‘Educational Training Committee’ to cultivate professional monitors to improve expertise knowledge and working ability. We provide initiation training of monitor, role-playing and OJT (office/field work). After monitors finish attending all lectures and pass the examination, the chairman of Educational Training Committee issues certificates of initiation training. After these trainings, monitors will take more practical and advanced trainings to immediate contribute to monitoring.
- Our experience in supporting studies in various therapeutic areas and diseases enable us to provide not only monitoring but also appropriate developing clinical trial plan proposals.
- We have a great deal of accomplishments in studies in areas requiring a high degree of professionalism, such as cancer, central nerve system and metabolism.
- We have allocated QC specialized staff to check on quality at all times, for improvement.
- We support Data and Safety Monitoring Board (DSMB) to operate properly in a neutral position independent from sponsors or investigators.
[ Contact ] Sales Department TEL +81-3-5804-7577 / FAX +81-3-5684-7872
[ Last Update ]