{ Quality Assurance }
Quality is the cornerstone of the DaVita philosophy, and DaVita Clinical Research (DCR) is committed to quality and accuracy throughout the clinical development process. DCR’s quality assurance auditors are knowledgeable concerning national and international regulations, standards, and guidelines, and play an active role in each study to ensure regulatory and sponsor requirements are met.
A function separate from other clinical operations, our quality control staff provides an independent, objective review of all clinical documentation and data. All source data generated from a clinical trial is checked for completeness, as well as protocol and Standards Operating Procedures (SOP) compliance.
Audits are conducted at various stages of the project according to a prepared quality plan. These include:
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Pre-trial audits
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In-process documentation audits
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Statistical audits
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Trial close-out audits
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Clinical study report audits
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Vendor audits
In addition, documented SOPs are implemented across all clinical sites, ensuring systems and processes are uniform and controlled. DCR employees are rigorously trained on good clinical practices (GCP) and good documentation practices (GDP), as well as applicable SOPs and protocol-specific training prior to conducting clinical activities. DCR staff members also participate in industry conferences and stay current with appropriate professional journals to keep abreast of regulatory and quality requirements.
