Providing Global Audit Service

Our independent department with extensive domestic and overseas quality assurance (QA) experience provides audit and QA services.

In 1999, the CMIC Group established an independent specialized department for the contracted audit business within the company. We provide the audit and QA services required in clinical trial implementation and regulatory approval application process with systems and resources that can efficiently and effectively perform according to the customer request. Above-mentioned services are for the audit and the QA operation up to the regulatory approval related to the development of all drugs, medical devices, regenerative medicine products, etc. Furthermore, we meet customer requests by utilizing domestic and overseas resources not only in audits in Japan but also in overseas bases mainly in Asia.

Our Edge in Audit & Quality Assurance

Broad Experience in Multiple Trial Types

  • Conducting audits in academia based on our extensive experience in conducting investigator-initiated clinical trials. Cost suppressed operations are also available upon consultation.
  • Providing a wealth of experience in auditing company-initiated clinical trials, investigator-initiated clinical trials, and clinical research, QA in the regulatory approval process, and self-inspection of post-marketing surveillance.
  • Through internal collaboration and sharing of information among global auditors in Japan and auditors at overseas bases, we can respond to audits complying with regulations in each country overseas.
  • With a wealth of resources, we can flexibly respond to various situations and schedules.

Services

  • Audit of company-initiated clinical trial and investigator-initiated clinical trial for drugs, medical devices, regenerative medicine products, etc.
  • Audit of clinical research for drugs, medical devices, regenerative medicine products, etc.
  • Audit of investigator site
  • Internal audit of sponsor
  • System audit of investigator site and sponsor
  • Audit and evaluation of CRO/Vendor
  • Dispatch of personnel responsible for audit
  • Preparation of SOP for audit and checklist
  • Consultation of QA system and support for creating SOP in companies and academia
  • QA (regulatory approval application support) and mock inspection

Related Service – Quality Management System

We support the construction of an efficient and functional Quality Management System (QMS) by promoting the experience of QMS operations at CMIC. CMIC has been highly praised by many customers for our QMS. We continuously strive to improve it by our experience in making a large number of operational proposals, and provide a service to construct QMS using this expertise.

  • Proposal of QMS
  • Support for creating quality policy, quality manual, and various SOPs related to QMS
  • Support for creating training materials

Project Management

Clinical Operations

Pharmacovigilance

Data Management

Statistical Analysis

Medical Writing

Consulting Services

Bioanalysis and GLP Analytical Services

Self-Inspection

Asia Clinical Trials