Quality Management System

QMS in Clinical Trials and SaMD Development　

In clinical trials, it is essential that the Quality Management System (QMS) functions effectively in practice.

Our company has established and operates an integrated QMS that meets the requirements of GCP, the QMS Ordinance, and ISO 13485 as a clinical trial organization.

One of our key strengths is our ability to build and maintain a transparent and well-documented quality management system, supported by mechanisms that manage quality at both the project and organizational levels.

Audit system that underpins reliability in clinical development

Audit framework for clinical development

In the clinical development of pharmaceuticals and medical devices, protecting study participants and ensuring the reliability of trial data are of paramount importance. To secure the quality of clinical trials and ensure compliance with regulatory requirements, it is essential to conduct audits from an independent standpoint.

Audit services that support various clinical development phases

To ensure reliability throughout the clinical development process of pharmaceuticals and medical devices, we conduct evaluations from a position independent of operational units and promote initiatives aimed at continuous improvement.

The Audit Department’s fundamental policy is to conduct timely and appropriate risk-based audits, thereby helping to prevent problems before they occur and to prevent their recurrence.

Audit support for advanced and highly specialized domains

We also conduct audits in highly advanced and specialized areas, such as project audits for SaMD (Software as a Medical Device) initiatives and system audits related to image analysis operations.

Audit support for a wide range of clinical trials

We provide audit services for a wide range of clinical trials, regardless of whether they are industry-sponsored or investigator-initiated, including pharmaceutical and medical device trials, clinical studies conducted under the Clinical Trials Act, and studies governed by ethical guidelines.

TMF/Trial Master File management

Effective TMF management is one of the most critical elements for ensuring the reliability of clinical trials.

We leverage a clinical trial platform to provide an environment where clinical trial data and documents can be managed in an integrated manner.

We also operate within a TMF management environment designed for international joint clinical trials and collaborations with overseas sponsors, ensuring full compliance with regulatory requirements.