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Quality Assurance

At R&G we understand that the ultimate goal for any of our clients is to receive a high quality design and execution of clinical trials that can withstand scrutiny from any inspectors and/or authorities. To this end, R&G’s quality management processes are integral to all aspects of our business. Our independent Quality Assurance (QA) department performs regular quality assessments of our services to ensure compliance with local Chinese medicinal and medical device regulations and international GCP regulations such as ICH and ISO. We also assess compliance with our SOPs and our commitment to customers.

Our experienced auditors conduct GxP (GCP, GCLP, GMP and GSP) audits on a rolling basis, ensuring GxP, clinical trial procedures and documentation processes as well as providing peace of mind for customers. In addition, QA operates a robust vendor qualification process and regularly administers vendor audits through a variety of mechanisms to ensure all R&G’s vendors meet or exceed our stringent standards.

At R&G we believe in quality by design. Our comprehensive SOPs and robust training programs as well as leadership’s commitment to quality facilitate each team member to work to the high standards our clients have come to expect. Today each R&G location (including subsidiaries) operates under our centralized quality management system.

Our Quality Assurance Services include:

  • Investigator Site Audits
  • Trial Master File (TMF) Audits
  • Clinical document Audits (protocol, ICF, CRF, study plans and CSR)
  • Database and Statistical Analysis Audits
  • System/Process Audits
  • Third Party Audits (central lab, central reading facility, IMP depot, EDC/CTMS/IXRS vendor, phase I unit, CRO/SMO)
  • Pre-inspection on-site preparation visit
  • On-site facilitation of health authority inspections
  • GxP training program

Please contact us for additional information on how our Quality Assurance team can help improve the quality of your clinical studies.

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