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Quality Assurance in Clinical Trials

Quality Assurance in clinical research defines quality at Rho

At Rho, Quality Assurance (QA) is an independent group that promotes excellence by ensuring adherence to our processes, applicable regulations, and Good Clinical Practices (GCP). Our auditors' focus on quality has been honed by years of multidisciplinary clinical research training, from extensive education on topics from software validation to GCP to FDA requirements.

Guided by principles and practices

Our QA team is guided by GCP, federal regulations, and client specifications. Each internal Rho team relies on the depth of industry experience and broad practical focus of the QA team. Because each client and situation is different, services are tailored to each project in the following areas:

  • GCP quality system development
  • GCP compliance and due diligence auditing including overall and study-specific compliance. Examples of types of audits include:
    • Clinical investigator site audits
    • Vendor and subcontractor qualification audits
    • Internal operations compliance including process audits, process QC reviews, and departmental system audits
    • Audits of key deliverables or study components, including study process documents, trial master files, reports, tables, and listings
    • Software and computer system validation documentation reviews
    • Independent database audits
    • Client systems audits
  • Development of Corrective and Preventive Actions (CAPA)
  • Creation and review of standard operating procedures (SOPs), standard forms and templates, and study-specific procedural documents

Quality Assurance drives continuous improvement

Quality Assurance facilitates continuous improvement in clinical research through internal audits, policy and procedure creation, and support of corrective and preventive actions from external audit findings.

Click here to learn about the electronic submission process in addition to Rho's clinical quality assurance services.