Independent Third-Party Audit

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The Quality Assurance team of Gobroad Research Center (GRC) consists of members with backgrounds in medicine and pharmacy, each possessing 5 to 15 years of relevant experience in clinical trial audit. The team has extensive experience in the clinical trial audits of BE (Bioequivalence) studies, Phase I-III clinical trials, and expertise in Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), and Good Pharmacovigilance Practice (GVP) domains. Utilizing individually tailored audit plans for each project, the audit team delves into profound quality risks and issues, aiming to mitigate clinical trial risks. They provide optimal solutions and consultations for resolving quality issues, ensuring the high-quality execution of clinical trials.

Advantageous services that GRC can provide in third-party audits:
  • Clinical Trial Site Audits

  • Bioanalytical Laboratory Audits

  • TMF/eTMF Audits

  • PV Audits

  • Vendor Qualification Assessments