Services
QC
Our Quality Control (QC) program ensures the quality of the Clinical Trial by verifying that the pharmaceutical, medical device or post-marketing trial (including any investigator initiated clinical trial) is performed in compliance with the applicable law and/or regulation at the time, such as Japan’s Pharmaceutical Affairs Law (PAL), GCP, Trial Protocol, and Standard Operating Procedures (SOP).
(Contents of activities)
・Preparation of Standard Operating Procedure on Quality Control Activities.
・Verification of Monitoring Report. (Procedure and Case Monitoring)
・Verification of activities and documents for requesting investigation at sites, contracts and completion of a clinical study.
・Verification of activities and documents for control of the investigational pharmaceutical.
・Verification of the activities related to collection, assessment, communication on the safety information.
・Verification of activities and documents for managing clinical data such as Case Report Forms.
・Verification of Protocol.
・Verification of Clinical Study Report.
・Storage and management of all records of activities as state above.
(Strengths)
・There are two types of Monitoring Activities, Procedure Monitoring and Case Monitoring. Each QC personnel, specialized in the Procedure, and specialized in the Case, are combined as a team and assigned to each Clinical Trial to ensure the Quality Control of each monitoring activity in an efficient manner.
・Considering the importance of Case Monitoring, mainly specific QC personnel with extensive experience in Monitoring are assigned to the verification of the Case Monitoring.
・The Monitoring Report prepared by CRA shall be verified immediately upon completion, and shall be reflected in further activities in an appropriate manner.
・The consistency between the Monitoring Report and the documents for requesting investigation at sites, contracts, and completion of the clinical trial are verified on a real-time basis.
・Process Control (the control of the date and the content of the performance) of the Monitoring Report is conducted to verify that the monitoring report is prepared properly.
・The Quality Control (QC) Activity is able to accept a request for a single QC project separated from the QC associated with the contracted Monitoring.
・The Quality Control Activity is able to accept QC requests to verify not only the activity associated with the Monitoring but also the content of the protocol, clinical trial report, etc.
