Overview
Essential Quality Assurance Services
Quality assurance is an essential expectation in the research industry. It ensures that studies adhere to relevant domestic and international regulations, while improving functionality and streamlining workflows.
Regulatory Consultation
Whether your study would benefit from a third-party audit to identify compliance gaps, or requires assistance in validating a commercial product, our Quality Assurance department can provide regulatory consultation to help determine which solutions best fit your needs.
All Phases of the Study Lifecycle
Our quality team is familiar with the regulatory aspects of all phases of the study lifecycle including:
Conduct Gap Analyses
Draft Standard Operating Procedures
Set Up Quality Assurance Workflows
Track Latest Protocols & Regulations
Our Quality Team
To develop quality assurance workflows, the Quality Assurance department works closely with other organizational departments, including Software Engineering, Data Management, IT, Biostatistics, Randomization, Database Operations, CDISC, and User Support.
We also partner with our highly-talented Technical Writing department to provide tailored documentation, training materials, and full validation suites.
Quality Assurance Process
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Consultation
A regulatory consultation is conducted to discuss the unique aspects of the study and determine the overall goals of the collaborator
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Analysis
A detailed gap analysis identifies potential compliance gaps and establishes approaches best suited for project needs
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Development
A strategic plan is created based on project requirements, including flexible workflows, tailored documentation and training, and full software validation suites where required
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Implementation
Our expert team provides direct assistance to ensure the successful implementation of customized workflows
