Service

     1.  Auditing

　　・Based on the latest international / regional regulatory requirements and trends in regulatory authority

　　　inspections, etc., TQAN provides contract based quality assurance services for clinical trials and clinical research.

　　・Primary areas: GCP, GPSP, GLM*), GMP*) and clinical research (Clinical Trial ACT and others) 

　　・Price List: Save (1day) USD 2,000+, Regular (2days) USD 6,000+ and Premier (3days) USD 8,000+    

　  2．Consulting on planning and implementation of clinical trials and Clinical Researches

　　・For companies, academia, and clinical investigator sites, TQAN provides consulting service for each process of clinical

         trial / clinical research such as planning, preparation, implementation, and submission for approval.

　　・Task areas: Study Concept Preparation, Establishment of Clinical Trial Organization, Monitoring, Data Management *),

         Statistical Analysis*), Clinical Research Report, Quality Control, Quality Assurance, Quality Management System (QMS)

　　　　*Supported by business cooperation with SME (Subject Matter Expert).

     3．Regulatory Inspection Readiness

      ・Provide advice and support regulatory inspection readiness and preparation (PMDA, FDA, EMA, etc.).

     4．Educational Training for Clinical Research Professionals

　　・Provides training programs for clinical research coordinators (CRCs), monitoring staff (CRAs), auditors, etc., as well as the 

         instructors dispatching.

　　[Examples of training programs]
  　　　QMS, RCA / CAPA, SDR and SDV, Monitorin / Auditing in Multinational Clinical Trials, Trend and readinass for 

           regulatory Inspection (PMDA/FDA/EMA/MHRA), Central IRB, Patient and Public Involvement (PPI).

　　　・Intensive exam taker training for international certification (ACRP: CCRC®, CCRA®, CPI® and CP®)