Quality Control

Top Page > Services > Quality Control

Quality control from documentation to assure the quality of clinical trials

Quality control work is the work that confirms from documentation whether or not a clinical trial is being carried out in accordance with GCP, the Pharmaceutical Affairs Law and the protocol and also whether monitoring is being carried out appropriately. Quality control work thus occupies an important position to assure the quality of clinical trials.
At ACRONET, we conduct inspections, including the content of documents,to see whether or not the documents that monitors create, the data that monitors submit to medical institutions, and the data that monitors obtain from the medical institutions in the conduct of clinical trials (these are called "essential documents") are created and submitted in accordance with GCP, the Pharmaceutical Affairs Law and the protocol. In addition, we confirms whether or not the necessary procedures are being conducted at the appropriate time with monitoring reports, etc., and manage quality control based on documentation so that appropriate monitoring work shall be implemented.

Work Flow

Work Flow

Page Top

List of Main Services

  • Creation of standard operating procedures related to quality control
  • Inspection of work related to clinical trial procedures
  • Inspection of work related to collection, evaluation and communication of safety information, etc.
  • Inspection of work related to investigational product management
  • Inspection of monitoring reports
  • Storage and management of records related to quality control work

Page Top